3476 lines
181 KiB
Python
3476 lines
181 KiB
Python
#!/usr/bin/env python3
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"""
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Přidá pole 'excel' ke každému investigátorovi v feasibility.investigators
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na základě dat z CHARGE a IBD LIST OF SITES záložek.
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Spustit: python update_excel_fields.py
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"""
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from pymongo import MongoClient
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import json
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MONGO_URI = "mongodb://192.168.1.76:27017/"
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client = MongoClient(MONGO_URI)
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col = client["feasibility"]["investigators"]
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updates = [
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{
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"filter": {
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"prijmeni": "Lukas"
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},
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"excel": {
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"Fire Site Id": "30047063",
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"Site Segmentation": "Key",
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"Site Name": "ISCARE a.s.",
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"Site Address": "Českomoravská 2510/19 Prague Prague",
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"Site City": "Prague",
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"PI Segmentation": "Key",
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"Pi First Name": "Milan",
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"Pi Last Name": "Lukas",
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"PI Phone": "420234770299",
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"Pi Email": "studie.lukas@email.cz",
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"Global Tier": "1",
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"Country Tier": "1",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano rejected. Chceme do Charge.",
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"SIPIQ": "odmítl",
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"SIPIQ info (pacienti a další)": "N/A"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Bortlik"
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},
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"excel": {
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"Fire Site Id": "30044460",
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"Site Segmentation": "Core",
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"Site Name": "Nemocnice Ceske Budejovice, a.s.",
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"Site Address": "Boženy Němcové 585/54 České Budějovice Jihočeský kraj",
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"Site City": "České Budějovice",
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"PI Segmentation": "Key",
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"Pi First Name": "Martin",
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"Pi Last Name": "Bortlik",
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"PI Phone": "420234770231",
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"Pi Email": "mbortlik@seznam.cz",
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"Global Tier": "1",
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"Country Tier": "1",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected UC only. Chceme do Charge.",
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"LP comment": "PI nekontaktován z důvodu problémů s nedostupností SD a přetíženosti SC",
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"OMS": "ORG-100046277\nLOC-100076350",
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"SM": "máme varování, že nebrat, nebudeme uhánět"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Siroky"
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},
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"excel": {
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"Fire Site Id": "30140800",
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"Site Segmentation": "Core",
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"podpis před EU CTR schvalenim": "ano",
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"Site Name": "Gastroenterologie, s.r.o., Hradec Kralove",
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"Site Address": "Mánesova 646 Hradec Králové Královéhradecký kraj",
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"Site City": "Hradec Králové",
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"PI Segmentation": "Core",
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"Pi First Name": "Milan",
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"Pi Last Name": "Siroky",
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"PI Phone": "420721405317",
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"Pi Email": "m.sirokydr@gmail.com",
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"Global Tier": "1",
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"Country Tier": "1",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, nechtěl, Ivetka. Máme ho v Anthemu, chtěli bychom ho do Charge.",
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"LP comment": "18.7.- má zájem, jen mu nepřišel SipIQ- prosím zaslat na m.sirokydr@gmail.com",
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"zájem o DUET": "ANO",
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"SIPIQ": "ANO",
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"SIPIQ info (pacienti a další)": "8 pacientů, IUS nechce. ujasnit Q81- specifické požadavky na handheldy",
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"CDA": "ANO 24Jul25\nVTMF-23897260",
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"OMS": "ORG-100048229\nLOC-100079801",
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"SM": "Agi (případně Ivetka)",
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"SQV termín": "onsite 20.8. v rámci předávání Anthemu",
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"SQV info (poslední věta v reportu) a jestli centrum vybíráme": "ANO. Příprava Skyrizi na centru (jsou tak zvyklí, nechce v lékárně). Mají SOP? Dr bude psát do zdrojovky.",
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"SQV pacienti": "8 pacien+W4:W16tů",
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"SQV konkurenční studie": "Žádné, Anthem skončí koncem roku",
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"SQV vybavení": "CHladnička v lékárně",
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"SQV smlouva": "Trojstranná včetně lokální laborky a lékárny",
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"Kompenzace": "Hotovost nebo stravenky. Tedy hotovost.",
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"IUS podstudie": "Ne"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Vanasek"
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},
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"excel": {
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"Fire Site Id": "30045763",
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"Site Segmentation": "Core",
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"podpis před EU CTR schvalenim": "ano",
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"Site Name": "Hepato-gastroenterologie HK, s.r.o.",
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"Site Address": "třída Edvarda Beneše 1549/34 Hradec Králové Královéhradecký kraj",
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"Site City": "Hradec Králové",
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"PI Segmentation": "Base",
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"Pi First Name": "Tomas",
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"Pi Last Name": "Vanasek",
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"PI Phone": "420495218475",
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"Pi Email": "tomas.vanasek@hepato-gastro.com",
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"Global Tier": "1",
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"Country Tier": "1",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano rejected. Chceme do Charge.",
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"zájem o DUET": "ANO",
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"SIPIQ": "ANO",
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"SIPIQ info (pacienti a další)": "5 pacientů, IUS nechce, ujasnit Q81- specifické požadavky na handheldy",
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"CDA": "ANO 07Aug25\nVTMF-23920652",
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"OMS": "ORG-100042224\nLOC-100069704",
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"SM": "Ivetka",
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"SQV termín": "onsite 14.8. 14:30",
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"SQV info (poslední věta v reportu) a jestli centrum vybíráme": "ANO. Fakturace léku po aplikaci. Lék objednávají z Iscare, kde je sledována teplota při transportu. Příprava Skyrizi v lékárně.",
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"SQV pacienti": "5 pacientů (3 pacienti na rok)",
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"SQV konkurenční studie": "14 studií, aktivní nábor u CD 1 studie v roce 2026",
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"SQV vybavení": "Vše mají. Mají mrazák mínus 70. Nemají kalibraci na teploměr. Jsou tam jenom vzorky. Zkusit teploměr s kalibrací.",
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"SQV smlouva": "Trojstranná včetně lokální laborky a lékárny (lékárnu mají zasmluvněnou sami)",
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"Kompenzace": "Preference hotovosti a kvartálně zálohové faktury",
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"IUS podstudie": "Ne"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Stepek"
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},
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"excel": {
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"Fire Site Id": "30152540",
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"Site Segmentation": "Base",
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"podpis před EU CTR schvalenim": "nutno overit",
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"Site Name": "Vojenska nemocnice Brno",
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"Site Address": "Zábrdovická 3",
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"Site City": "Brno",
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"PI Segmentation": "Core",
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"Pi First Name": "David",
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"Pi Last Name": "Stepek",
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"PI Phone": "420973445401",
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"Pi Email": "dstepek@vnbrno.cz",
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"Global Tier": "0",
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"Country Tier": "0",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected",
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"LP comment": "17Jul- má zájem, ale nenašel email (měli v nemocnici výpadek sítě).",
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"zájem o DUET": "ANO",
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"SIPIQ": "ANO",
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"SIPIQ info (pacienti a další)": "7 pacientů, IUS nechce, Vyplnil sipIQ- že kupovat Skyrizi nelze,- ale poté potvrdil telefonicky, že lze, prosím upřesnit v reportu z SQV",
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"CDA": "ANO 18Jul25\nVTMF-23820467",
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"OMS": "ORG-100043479\nLOC-100071918",
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"SM": "Oxana",
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"SQV termín": "onsite, 7.8. ct, behem dne, ma sluzbu a bude mit cas. lekarna na 13:00",
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"SQV pacienti": "5 pacientů",
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"SQV konkurenční studie": "Iconic CD",
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"SQV vybavení": "Mají vše",
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"SQV smlouva": "Trojstranná",
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"Kompenzace": "Hotovost",
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"IUS podstudie": "?? (čeká na lékaře z dovolené)"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Voska"
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},
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"excel": {
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"Fire Site Id": "30047018",
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"Site Segmentation": "Base",
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"Site Name": "Nemocnice Horovice, a.s.",
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"Site Address": "K Nemocnici 14 Hořovice Středočeský kraj",
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"Site City": "Hořovice",
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"PI Segmentation": "Base",
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"Pi First Name": "Michal",
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"Pi Last Name": "Voska",
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"PI Phone": "420773200360",
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"Pi Email": "voska@nemocnice-horovice.cz",
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"Global Tier": "1",
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"Country Tier": "1",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, vedená Serclova, která ve FNKV",
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"LP comment": "17Jul- nemá zájem, je příliš vytížený. Nové studie nyní nechce dělat.Možná za 2 - 3 roky přehodnotí.",
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"SIPIQ": "odmítl",
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"SIPIQ info (pacienti a další)": "N/A",
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"CDA": "N/A",
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"SM": "Ivetka"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Hrdlicka"
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},
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"excel": {
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"Fire Site Id": "30045952",
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"Site Segmentation": "Base",
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"Site Name": "ResTrial GastroEndo, s.r.o",
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"Site Address": "Sofijské náměstí 3404/3 Prague Prague",
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"Site City": "Prague",
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"PI Segmentation": "Base",
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"Pi First Name": "Ludek",
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"Pi Last Name": "Hrdlicka",
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"PI Phone": "42736772445",
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"Pi Email": "ludek.hrdlicka@restrial.com",
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"Global Tier": "3",
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"Country Tier": "3",
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"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, nechtěl",
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"LP comment": "17Jul- je na dovolené a tak neodpověděl na email, \n21Jul- momentálně rozjíždí 2 nové studie a na víc nemá kapacitu. Nové nabídky případně můžeme zaslat, ale teď nemá zájem.",
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"SIPIQ": "odmítl",
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||
"SIPIQ info (pacienti a další)": "N/A",
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"CDA": "N/A"
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},
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"zdroj_sheet": "CHARGE"
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},
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{
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"filter": {
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"prijmeni": "Serclova"
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},
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"excel": {
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"Fire Site Id": "30045108",
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"Site Segmentation": "Base",
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||
"podpis před EU CTR schvalenim": "ano",
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||
"Site Name": "Fakultni nemocnice Kralovske Vinohrady",
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"Site Address": "Šrobárova 50",
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"Site City": "Prague",
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"Pi First Name": "Zuzana",
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"Pi Last Name": "Serclova",
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"PI Phone": "420266082165/ 602 158 805",
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"Pi Email": "sercl@seznam.cz",
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"Global Tier": "0",
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||
"Country Tier": "0",
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||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected CD only, Ivetka. Má zájem o Charge.",
|
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"LP comment": "17Jul- Dr.Šerclová slíbila, že se koukne na email a SipIQ a dá vědět (rozjíždí teď 3 studie a neví jak to bude stíhat)\n21.7.- odesláno upozornění na vyplnění\n23.7.- ve 12:45 je na sále, volat kolem 15h. 15:00 Slíbila se, že se na sipIQ teď podívá.",
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"zájem o DUET": "ANO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "3 pacienty, IUS nechce, ujasnit Q81- specifické požadavky na handheldy, Vyplnila sipIQ- že kupovat Skyrizi nelze poté\" telefonicky upřesnila, že lze, prosím upřesnit v reportu z SQV",
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||
"CDA": "master 09Mar23\nVTMF-23383494",
|
||
"OMS": "ORG-100029480\nLOC-100046792",
|
||
"SM": "Ivetka",
|
||
"SQV termín": "26.8. ve 14:30 onsite",
|
||
"SQV info (poslední věta v reportu) a jestli centrum vybíráme": "ANO. Biol lecbu pacienty posílají do Iscare. Z lékárny objednání Skyrizi neměl by být problém. Jenom jeden gastroenterlog Martin Lukáš.",
|
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"SQV pacienti": "3",
|
||
"SQV konkurenční studie": "2 studie na CD s náborem v roce 2026.",
|
||
"SQV vybavení": "Vše kromě inkubátoru a ten zapůjčený v Iconicu. 3 endoskopy - pak dokumentace ke všem.",
|
||
"SQV smlouva": "Dvojstranná (instituce a sponzor), přes mgr Brožová, včetně lékárny a lok, laborky",
|
||
"Kompenzace": "Hotovost. Stravenky nechtějí pacienti.",
|
||
"IUS podstudie": "Ne"
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||
},
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||
"zdroj_sheet": "CHARGE"
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||
},
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{
|
||
"filter": {
|
||
"prijmeni": "Kozeluhova"
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||
},
|
||
"excel": {
|
||
"Fire Site Id": "30047682",
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||
"Site Segmentation": "Dormant",
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||
"Site Name": "Fakultni nemocnice Plzen",
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||
"Site Address": "Alej Svobody 80 Pilsen Plzeňský kraj",
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||
"Site City": "Pilsen",
|
||
"PI Segmentation": "Dormant",
|
||
"Pi First Name": "Jana",
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||
"Pi Last Name": "Kozeluhova",
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||
"PI Phone": "420377103322, 377103331- lékařák",
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||
"Pi Email": "kozeluhova@fnplzen.cz",
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||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, nemají personál, ale Medical chtěl",
|
||
"LP comment": "18.7.- má dovolenou, volat ve čtvrtek 24.7.\n25.7.- mají podstav- oočekávají nástup dvou nových kolegů někdy příští rok, pak by byli schopni provést studii.",
|
||
"SIPIQ": "odmítla",
|
||
"SIPIQ info (pacienti a další)": "N/A",
|
||
"CDA": "master 30May25\nvTMF ???",
|
||
"SM": "Oxana"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Ulbrych"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30044708",
|
||
"Site Name": "SurGal Clinic",
|
||
"Site Address": "307 Drobného Černá Pole",
|
||
"Site City": "Brno",
|
||
"Pi First Name": "Jan",
|
||
"Pi Last Name": "Ulbrych",
|
||
"PI Phone": "420543182418",
|
||
"Pi Email": "ulbrych.jan@surgalclinic.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano, rejected sám, i když byl vybrán. Chceme do Charge kdyby chtěl.",
|
||
"LP comment": "SipIQ- nesedí počet pacientů ADT treated vs ADT treatment failure za rok (Q41 vs Q421)",
|
||
"zájem o DUET": "ANO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "3 pacienty, IUS chce, nemá mrazák na -70stC",
|
||
"CDA": "ANO 14Jul25\nVTMF-23781754",
|
||
"OMS": "ORG-100046124\nLOC-100076087",
|
||
"SM": "Oxana",
|
||
"SQV termín": "onsite, 8.8 ct, 11:30, odpoved za lekarnu cekam",
|
||
"SQV pacienti": "3 pacienti",
|
||
"SQV konkurenční studie": "Nemají",
|
||
"SQV vybavení": "Mrazák jenom mínus 20, jinak vše mají",
|
||
"SQV smlouva": "Trojstranná",
|
||
"Kompenzace": "Hotovost",
|
||
"IUS podstudie": "Ano"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Pipek"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30044693",
|
||
"Site Name": "Vitkovicka nemocnice a.s.",
|
||
"Site Address": "Zalužanského 1192/15",
|
||
"Site City": "Ostrava",
|
||
"Pi First Name": "Barbora",
|
||
"Pi Last Name": "Pipek",
|
||
"PI Phone": "420595633205",
|
||
"Pi Email": "barbora.pipek@seznam.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Neoslovena",
|
||
"LP comment": "Momentálně nemají zájem .",
|
||
"SIPIQ": "odmítla",
|
||
"SIPIQ info (pacienti a další)": "N/A"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Svoboda"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30045883",
|
||
"podpis před EU CTR schvalenim": "nemocnice podepisuje az po schveni, ale JnJ a PI muzou mit podepsane",
|
||
"Site Name": "Fakultni nemocnice Ostrava",
|
||
"Site Address": "17. listopadu 1790",
|
||
"Site City": "Ostrava",
|
||
"Pi First Name": "Pavel",
|
||
"Pi Last Name": "Svoboda",
|
||
"PI Phone": "420597374191",
|
||
"Pi Email": "pavel.svoboda@fno.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano rejected, váhali v tu dobu",
|
||
"zájem o DUET": "ANO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "5 pacientů, IUS chce, nemá inkubátor",
|
||
"CDA": "ANO",
|
||
"OMS": "ORG-100030731\nLOC-100048362",
|
||
"SM": "Oxana",
|
||
"SQV termín": "onsite, 14.8, od 12 hod. lekarna v jednani",
|
||
"SQV pacienti": "5 pacientů",
|
||
"SQV konkurenční studie": "Nemají",
|
||
"SQV vybavení": "Vše",
|
||
"SQV smlouva": "Trojstranná včetně lékárny a lok. laborky",
|
||
"Kompenzace": "Hotovost",
|
||
"IUS podstudie": "Ano"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Mudr"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30046814",
|
||
"Site Name": "Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze",
|
||
"Site Address": "36 Vlasska Mala Strana",
|
||
"Site City": "Praha 1- Mala Strana",
|
||
"Pi First Name": "Robert",
|
||
"Pi Last Name": "Mudr",
|
||
"PI Phone": "4203257197111 | 420257197305",
|
||
"Pi Email": "robert.mudr@nmskb.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected. Chceme do Charge. Ivetka nebo i Oxana, která ho zná.",
|
||
"LP comment": "komunikaci s centrem řeší Oxana",
|
||
"SIPIQ": "odmítl, chce nabrat Iconic",
|
||
"CDA": "NA",
|
||
"SM": "Oxana"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Minarikova"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30127373",
|
||
"Site Name": "Ústrední vojenské nemocnice Praha",
|
||
"Site Address": "U Vojenské nemocnice 1",
|
||
"Site City": "Prague",
|
||
"Pi First Name": "Petra",
|
||
"Pi Last Name": "Minarikova",
|
||
"PI Phone": "603 482 476 od Ivet, \n(špatné číslo 420608965907",
|
||
"Pi Email": "petra.minarikova@uvn.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano rejected, nemá zástup v ambulanci, ivetka",
|
||
"LP comment": "603 482 476, na dovolené do 24.7., \n25.7.- nelze se dovolat, hlasová schránka na email přišla odpověď, že je mimo kancelář v době 24.7.-11.8.2025",
|
||
"SIPIQ": "nezastižena",
|
||
"CDA": "ANO 10Jul25\nVTMF-23781784",
|
||
"SM": "Ivetka"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Konecny"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30132711",
|
||
"podpis před EU CTR schvalenim": "ne, nesmi se ani nic delat predem, mozne pouze online treninky",
|
||
"Site Name": "Fakultni nemocnice Brno",
|
||
"Site Address": "Jihlavská 20",
|
||
"Site City": "Brno",
|
||
"Pi First Name": "Stefan",
|
||
"Pi Last Name": "Konecny",
|
||
"PI Phone": "420775161464",
|
||
"Pi Email": "konecny.stefan@fnbrno.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected",
|
||
"zájem o DUET": "ANO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "5 pacientů, IUS chce, ověřit zkušenosti s KH, dle sipIQ 1/2 pacientu na ADT má selhání???",
|
||
"CDA": "master 19Dec22\n VTMF-23185021",
|
||
"OMS": "ORG-100022981\nLOC-100031711",
|
||
"SM": "Oxana",
|
||
"SQV termín": "onsite, 7.8, ct od 8:00, lekarnu pokusim se domluvit sama",
|
||
"SQV pacienti": "5 pacientů",
|
||
"SQV konkurenční studie": "Nemají",
|
||
"SQV vybavení": "Mají vše",
|
||
"SQV smlouva": "Trojstranná plu s hlavním zkoušejícím",
|
||
"Kompenzace": "Hotovost",
|
||
"IUS podstudie": "Ano"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Konecny"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30047960",
|
||
"Site Name": "Fakultní nemocnice Olomouc",
|
||
"Site Address": "I.P. Pavlova 6",
|
||
"Site City": "Olomouc",
|
||
"Pi First Name": "Michal",
|
||
"Pi Last Name": "Konecny",
|
||
"PI Phone": "+420 581 201 691",
|
||
"Pi Email": "michal.konecny@fnol.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected",
|
||
"LP comment": "18.7.- v Pá nebývá , volat v Po kolem 12 nebo pak před 13 h, mají otevřeno až do 14\n21.7.- email viděl, ale myslel, že je to k ICONIC. Přeposlala jsem email znova a slíbil že zítra (Út 22.7) zkoukne a vyplní.",
|
||
"zájem o DUET": "NO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "4 pacienty, IUS nechce, ověřit site staff, ověřit zkušenosti s KH, nemá inkubátor a centrifigu, ujasnit Q81- specifické požadavky na handheldy",
|
||
"CDA": "master 05Apr23\nVTMF-21240029",
|
||
"OMS": "ORG-100032988\nLOC-100076870",
|
||
"SM": "Oxana",
|
||
"SQV termín": "onsite, 14.8 ct, jeste potvrdi na zacatku srpna. schuzka jen s nim, s lekarniky az bude mit poredstavu o rozpoctu...",
|
||
"SQV pacienti": "3 pacienti",
|
||
"SQV konkurenční studie": "Jen Iconic CD",
|
||
"SQV vybavení": "Není inkubátor a centrifuga (přes Iocnic)",
|
||
"SQV smlouva": "Dvojstranná (instituce a sponzor), včetně lékárny a lok, laborky",
|
||
"Kompenzace": "SPíše stravenky",
|
||
"IUS podstudie": "Ne"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vyhnalek"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30046344",
|
||
"Site Name": "Pardubicka krajska nemocnice a.s.",
|
||
"Site Address": "Kyjevská 44",
|
||
"Site City": "Pardubice",
|
||
"Pi First Name": "Petr",
|
||
"Pi Last Name": "Vyhnalek",
|
||
"PI Phone": "420466014209, 4229 (endoskopie), nebo přes recepci\n4201- kancelář PI",
|
||
"Pi Email": "petr.vyhnalek@nempk.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ano selected jako Leksa, ale nemá zájem o dalsi studie",
|
||
"LP comment": "18.7.- pan primář je na dovolené, volat v pondělí 21.7. na endoskopii\n21.7.- dnes se vrátil z dovolené a nestíhá. Dle dohody email s dotazníkem přeposlán znova. Podívá se na to zítra (Út 22.7.)\n23.7.- dnes končil okolo 11h a bude až v pátek 25.7., volat cca v 8h do PI kanceláře\n25.7.- nestíhají, studii teď nechtějí",
|
||
"SIPIQ": "odmítl",
|
||
"SIPIQ info (pacienti a další)": "N/A",
|
||
"CDA": "zasláno k podpisu"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Kohout"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30133665",
|
||
"podpis před EU CTR schvalenim": "podepisou, ale nechaji si smlouvu u sebe, ale dovoluji iniciace, registr az po schvaleni, smlouvu daji hned po schvaleni",
|
||
"Site Name": "Thomayerova nemocnice",
|
||
"Site Address": "Vídeňská 800",
|
||
"Site City": "Prague",
|
||
"Pi First Name": "Pavel",
|
||
"Pi Last Name": "Kohout",
|
||
"PI Phone": "420261083134- fax| 420261082295",
|
||
"Pi Email": "pavel.kohout@ftn.cz;",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Neosloven",
|
||
"LP comment": "18.7.- uvedené tel,č je na sekretariát. sekretářka předá informaci. Pan docent má dovolenou 22.-24.7. (= bude v pondělí 21.7. a v pátek 25.7.)\n21.7.- sekretářka potvrdila, že informace předalal, ale po dohodě přeposílám email i na ni- michaela.grundova@ftn.cz\n23.7.- sekretářka potvrdila, že vyplňoval, ale nevidím v Qualtrics- již OK",
|
||
"zájem o DUET": "ANO",
|
||
"SIPIQ": "ANO",
|
||
"SIPIQ info (pacienti a další)": "15 pacientů, IUS chce (nemá zkušenosti s nahráváním kolonoskopie a IUS), při SQV - ujasnit nahrávání záznamu kolonoskopie (Q35)",
|
||
"CDA": "master 30Oct23\nVTMF-21240047",
|
||
"OMS": "ORG-100030941",
|
||
"SM": "Agi a Ivetka - performance",
|
||
"SQV termín": "31.7. ve 14:30 on site",
|
||
"SQV info (poslední věta v reportu) a jestli centrum vybíráme": "ANO. S dr Škopkem jako podpora.",
|
||
"SQV pacienti": "5 pacientů",
|
||
"SQV konkurenční studie": "Nemají",
|
||
"SQV vybavení": "Vše mají",
|
||
"SQV smlouva": "Trojstranná smlouva včetně lokální laborky a lékárny",
|
||
"Kompenzace": "Hotovost",
|
||
"IUS podstudie": "Ano"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Douda"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30047879",
|
||
"Site Name": "Fakultni nemocnice Hradec Kralove",
|
||
"Site Address": "Sokolská 581",
|
||
"Site City": "Hradec Králové",
|
||
"Pi First Name": "Tomas",
|
||
"Pi Last Name": "Douda",
|
||
"PI Phone": "49583 linka 3818, 3437",
|
||
"Pi Email": "tomas.douda@fnhk.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, nemají kapacitu",
|
||
"LP comment": "They can't keep up, they don't want to study now",
|
||
"SIPIQ": "odmítl",
|
||
"SIPIQ info (pacienti a další)": "N/A",
|
||
"CDA": "N/A"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Novotny"
|
||
},
|
||
"excel": {
|
||
"Fire Site Id": "30133663",
|
||
"Site Name": "Vseobecna fakultni nemocnice v Praze",
|
||
"Site Address": "U Nemocnice 2",
|
||
"Site City": "Prague",
|
||
"Pi First Name": "Ales",
|
||
"Pi Last Name": "Novotny",
|
||
"PI Phone": "4200224962486| 4200224962506| 4200224962427",
|
||
"Pi Email": "Ales.Novotny@vfn.cz",
|
||
"Global Tier": "0",
|
||
"Country Tier": "0",
|
||
"Iconic Legenda: Ano je, že se účastnili Iconic IBD feasky, pak bud vybráni (sele": "Ne, osloven a vybrán Hrabak z VFN ve své ambulanci",
|
||
"LP comment": "18.7. má dovolenou, volat v pondělí 21.7. ( lůžkové oddělení B- linka 9337), \n21.7. dopoledne je na endoskopiích, ve 13h zrovna nezastižen- doběhl, volat cca v 14h\n23.7.- 15:00 nikdo nezvedá\n25.7.- dopoledne opakovaně obsazeno na lince 9337, doporučena linka 2476, (sestry), sestry doporučili ultrazvuk 2467- má školení neberou- volat na lůžkové cca 13:15, 14:00- neví zda to bude stíhat přeposlán znova email se sipIQ",
|
||
"SIPIQ": "odmítla",
|
||
"SIPIQ info (pacienti a další)": "N/A",
|
||
"CDA": "master 18Jan23\nVTMF-21240055"
|
||
},
|
||
"zdroj_sheet": "CHARGE"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Zimen"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"SM": "NA",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "není ani v Iluminatoru, žádná akce tam",
|
||
"Comment": "10APR2025 Dotaz na možnost účasti v adolescentní větvi UC, ale nemá zájem z kapacitních důvodů",
|
||
"Společnost na CDA": "Nemocnice Jihlava",
|
||
"PI Last Name": "Zimen",
|
||
"PI First Name": "Martin",
|
||
"Plné jméno": "MUDr. Martin Zimen",
|
||
"PI Email Address": "zimenm@nemji.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Melek"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"SM": "NA",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "NA",
|
||
"Comment": "11APR2025 Už tam nepracuje, přeposlal kolegovi, ale nenapsal kterému\n17APR2025 pracuje Dr. Melek, ale nechtějí",
|
||
"Společnost na CDA": "Fakultní nemocnice Hradec Králové",
|
||
"PI Last Name": "Melek",
|
||
"PI First Name": "Jan",
|
||
"Plné jméno": "MUDr. Jan Melek",
|
||
"PI Email Address": "jan.melek1@gmail.com"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Zahradníček"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"SM": "NA",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "NA",
|
||
"Comment": "17APR2025 neodpověděl, nemá tedy zájem\n11APR2025 reminder 2\n09APR2025 žádost o účast v adolescentní větvi UC",
|
||
"Společnost na CDA": "Krajská nemocnice Ústí nad Labem",
|
||
"PI Last Name": "Zahradníček",
|
||
"PI First Name": "Lubomír",
|
||
"Plné jméno": "MUDr. Lubomír Zahradníček",
|
||
"PI Email Address": "lubomir.zahradnicek@kzcr.eu"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Ženišková"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_Lag2MX1qfv0nPid_b11cOvqU1TI0p3U_CGC_LPPXiClRvObQuBO&_g_=g",
|
||
"SM": "NA",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "25APR2025 začala vyplňovat a pak napsala, že je zavalena prací\n22APR2025 SIPIQ odeslán",
|
||
"Comment": "17APR2025 má zájem, doplnil jsem centrum do Iluminatoru, potřebuji nastavit zemi\n11APR2025 reminder 2\n09APR2025 žádost o účast v adolescentní větvi UC",
|
||
"Společnost na CDA": "Nemocnice České Budějovice",
|
||
"PI Last Name": "Ženišková",
|
||
"PI First Name": "Ivana",
|
||
"Plné jméno": "MUDr. Ivana Ženíšková",
|
||
"PI Email Address": "i.zeniskova@volny.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Kopet"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s dr Ženíšková děti",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_Lag2MX1qfv0nPid_b11cOvqU1TI0p3U_CGC_LPPXiClRvObQuBO&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- Dr.Kopet je v nemocnici ČB (Dětské oddělení- gastroenterolog) ve St, Čt, Pa. Dnes není k dispozici. Budu volat ve St 7.5.- dělá od 8:30 bude na l. 38787 6326 (okolo 9h), biologické léčby 6354 nebo 53\n7.5.- slíbíl že SipIQ vyplní, má zájem. Domluven termín SQV.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "20.5. v 10h remote\nrozmyslel si to nestíhá, nechce se účastnit",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "30APR2025 SIPIQ odeslán",
|
||
"Comment": "30APR2025 bude 8 dní pryč\n30apr2025 napsal, že chce vidět, posílám SIPIQ\n29APR2025 připomínka emailem\n25APR2025 Dr. Ženíšková mi dala tip na oslovení Dr. Kopeta",
|
||
"Společnost na CDA": "Nemocnice České Budějovice",
|
||
"PI Last Name": "Kopet",
|
||
"PI First Name": "Antonín",
|
||
"Plné jméno": "MUDr. Antonín Kopeta",
|
||
"PI Email Address": "kopet.antonin@nemcb.cz",
|
||
"PI Phone Number": "38787 6326 nebo ambulance 38787 6311\n607 227 487"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Ťoukálková"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "NA",
|
||
"Comment": "17APR2025 neodpověděla, nemá zájem\n11APR2025 reminder 2\n09APR2025 žádost o účast v adolescentní větvi UC",
|
||
"Společnost na CDA": "Krajská nemocnice Tomáše Bati",
|
||
"PI Last Name": "Ťoukálková",
|
||
"PI First Name": "Lenka",
|
||
"Plné jméno": "MUDr. Lenka Ťoukálková",
|
||
"PI Email Address": "toukalkova@bnzlin.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Šuláková"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_15BdYXMEJFdf7W9_b11cOvqU1TI0p3U_CGC_2wRKnkQCn6FAGjj&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "dle ww stránek v ambulanci - Dr.Šuláková po,pá: 08,00-14,30 a út: 08,00-11,30,\n 2.5. v 10:00 ani po 14h- nikdo nezvedá. Zavolám v pondělí 5.5.\n5.5. má toho moc, slíbila, že vyplní SipIQ dnes nebo zítra. Jinak bude k dispozici v pátek 9.5. v ambulanci.\n9.5.- SipIQ paní doktorka vyplnila a odeslala při našem hovoru. Domluven termín SQV.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "21.5. v 13:30 \nremote",
|
||
"SIPIQ zajímavosti": "Nemá zkušenost s Mayo, ePRO, CSSRS, nemá SC (nemuselo by vadit - 1-2 pacienti), IATA, nemá inkubátor, IGRA a rtg hrudníku",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Adolescenti 2 (1:1)",
|
||
"Počet pacientů SQV": "2-3 screening/ 1-2 randomizovaní\nměli jen jednu studii a to byla 4 (neměli nikdy 2 ani 3 fázi)",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "SM does not recommend this site:\n - PI is inexperience (only one study phase IV.)\n - Insufficient study team - only one study nurse, PI is very busy and want to perform the role of SC Additonal comment: PI confirmed that site want to participate in the IUS sub-study.\nSub-Investigator will perform the IUS examination",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Adolescenti",
|
||
"FINAL DECISION PRO ICONIC IBD": "Not recommended",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "17APR2025 SIPIQ odeslán",
|
||
"Comment": "30APR2025 reminder k vyplnění feasibility dotazníku\n29APR2025 reminder, aby vyplnila feasibility dotazník\n11APR2025 má zájem o feasibility\n11APR2025 reminder 2\n09APR2025 žádost o účast v adolescentní větvi UC",
|
||
"Společnost na CDA": "Fakultní nemocnice Ostrava",
|
||
"PI Last Name": "Šuláková",
|
||
"PI First Name": "Astrida",
|
||
"Plné jméno": "MUDr. Astrida Šuláková, PhD.",
|
||
"PI Email Address": "astrida.sulakova@osu.cz\nastrida.sulakova@fno.cz",
|
||
"PI Phone Number": "597 373 524"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Karásková"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "není ani v Iluminatoru, žádná akce tam",
|
||
"Comment": "10APR2025 nebude se účastnit\n09APR2025 žádost o účast v adolescentní větvi UC",
|
||
"Společnost na CDA": "Fakultní nemocnice Ostrava",
|
||
"PI Last Name": "Karásková",
|
||
"PI First Name": "Eva",
|
||
"Plné jméno": "doc. MUDr. Eva Karásková, PhD.",
|
||
"PI Email Address": "Eva.Karaskova@fnol.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vyhnánek"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_1nYMXUpJeUbk168_b11cOvqU1TI0p3U_CGC_ElYHCLBaVrdnqy3&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- číslo 261 082 328- 14h sestřička slíbila, že předá Dr.Vyhnánkovi vzkaz až se vrátí a ozve se sám zpět , neozval se, dodán nový tel.kontakt- 261 082 377- nikdo nezvedá. Budu volat v pondělí 5.5.. 261 083 798 \n5.5. - 12:30- Šel na oběd, volat cca v 13:30, na čísle 261 082 328 není a na lince 3798 je stále obsazeno, kdýž jsem se dovolalal tak nešel k telefonu (komunikace přes sestřičku) \nmá teď akutní případ, volat zítra 6.5. linka 261 082 328 okolo 9h \n6.5.- 9h prý je na ambulanci linka 3798,na ambulanci tvrdili, že je na lůžkovém a tam, že odešel na ambulanci (není k sehnání), možná bude na lůžkovém v 13:30. Ponechán vzkaz na ambulanci i na lůžkovém.\nVladovi na email odpověděl, že nestíhá a předal kontakt na Dr.. Lucií Gonsorčíkovou Ph.D. (261 083 180)\n9.5. Dr.Gonsorčíková má jednání- zanechán vzkaz- volala zpět a potvrdila, že SipIQ vyplnila a má zájem. SQV domuvena.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "28.5. v 13:30 \non-site",
|
||
"SIPIQ zajímavosti": "Nemá zkušenost s Mayo, ePRO, CSSRS,IATA",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Adolescenti 5 (3:2)",
|
||
"Počet pacientů SQV": "2 pacienti",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ano",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "NA",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "30APR2025 reminder, aby vyplnil feasibility dotazník\n29APR2025 reminder, aby vyplnil feasibility dotazník\n11APR2025 opakování\n09APR2025 opakování\n05APR2025 žádost o účast v adolescentní větvi UC\n15APR2025 chce do feasibility",
|
||
"Společnost na CDA": "Fakultní Thomayerova nemocnice",
|
||
"PI Last Name": "Vyhnánek\n Gonsorčíková",
|
||
"PI First Name": "Radim\nLucie",
|
||
"Plné jméno": "MUDr. Radim Vyhnánek\nMUDr. Lucie Gonsorčíková, PhD.",
|
||
"PI Email Address": "radim.vyhnanek@ftn.cz\nlucie.gonsorcikova@ftn.cz",
|
||
"PI Phone Number": "261 083 798 (ambulance), 2328 (lůžkové), 2377 (pokoj)\n739 089 650"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Falc"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_NlpwWPMSKtrY7Xe_b11cOvqU1TI0p3U_CGC_JHxt6JWa9lHqrx3&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- PI dopoledne nedostupný, ozval se, že je na dovolené. Zavoláme si příští týden (Po nebo Út 5.nebo 6.5.) a domluvíme termín SQV.\n5.5. domluven termín telefonické selekce",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "16.5. v 16h \nremote",
|
||
"SIPIQ zajímavosti": "Zadáno strašně málo pacientů ročně 3xCD a 5xUC. Chyba? \nLP- po SQV- Myšleno nový pacientů.\nNemá inkubátor a EKG a mrazák -70.\nNevychází počty.",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "2 (2:0) / 4 (2:0)",
|
||
"Počet pacientů SQV": "UC- 4 screenovaní- 2 randomizovaní\nCD- 3 screenovaní- 2 randomizovaní\nmá pouze biol. naivní pacienty",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "The PI has been involved in clinical trials since 2020 and has experience as a principal investigator in two clinical\ntrials at Slany Hospital. PI is communicative, well- cooperate and responsible.\nThis is small that would like to participate in clinical trials, but the unavailable devices (centrifuge and altimeter)\nneed to be resolved.\nThe PI would appreciate if these devices could be borrowed from Janssen for the study. Additional comments: PI will clarify whether the site will participate in the IUS sub-study - check with the radiologist for availability.\nPI confirmed that most patients will be able to use BYOD. He would like to receive a few handhelds on the site,\nfor those who don't have suitable phones. Falc v Anthemu U dr Peterky. Ostatní přístroje si koupí až mu potvrdíme. Potřeboval by centrifugu a vyskomer - ujistit se o zapujceni pres novy provider Vladku, ci jestli by slo koupit lokálně z penez studie. Bude potřebovat inkubator od centrály.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Zajímá se o další dvě studie, ale není centrum biolog lecby. Do SIPIQ dal jednotky léčených pacientů na UC a CD (error?). Spíše ne do dalších studiích, abychom viděli, jak to bude fungovat.",
|
||
"FINAL DECISION PRO ICONIC IBD": "Recommended",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "Fully executed",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "25APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "25APR2025 SIPIQ odeslán",
|
||
"Comment": "Chce se účasnit, není v Illuminatoru",
|
||
"Společnost na CDA": "Centrum gastroenterologie a hepatologie s.r.o.",
|
||
"PI Last Name": "Falc",
|
||
"PI First Name": "Matěj",
|
||
"Plné jméno": "MUDr. Matěj Falc",
|
||
"PI Email Address": "matesfalc@seznam.cz",
|
||
"PI Phone Number": "731 168 856"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hucl/Drastich"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Svetlana asi tedy namisto Drasticha a Benese??",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s doc Drastichem",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_I6JruiYAaeo76r6_b11cOvqU1TI0p3U_CGC_RlMoEDeeIYBPf7M&_g_=g",
|
||
"SM": "Dan",
|
||
"SM poznámky": "SIPIQ znovu odeslán po tel.domluvě přes sekretářku 5.5.25, přislíbila pana profesora upomenout. 7.5 prof. informuje , že orientačně vyplnil SIPIQ. Odkaz na Doc. Drasticha-zaslan e-mail ohledně stanoveni terminu selekce 11.5 a 12.5. upomínka přes paní sekretářku, 14.5. email upomenuti PI, sekretarka telefonicky",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "on-site 23.5 - PI 15:00\non-site 29.5. - SC 14:00",
|
||
"SIPIQ zajímavosti": "Nemají zkušenost s CDAI, Mayo, ePRO, CSSRS",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 5 (2:3) / 5 (2:3)",
|
||
"Počet pacientů SQV": "3 rand. UC a 3 rand. CD",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "2 a 2 studie bezi. Nejprve vsechno vi vsechno zna (doc drastich), az ke konci se ptal (pistele a dren). 4 xSI, 1xSC, 2-3x SN. Skladovani IMP v lekarne a vyzvedavat postupne, smlouva dvojstranna. Domluva komplikovanejsi jak s PI tak s SC. Jeste cekame na detaily endoskopu. Budou zařazovat spíše těžší pacienty co selhali 3 a více biol. lecby.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o obě studie. Uvedli, že léčí ročně 20 pacientů UC a 20 pacientů CD (error?) s poměrem 5:15 v obou",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO ale 7/10",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "09APR2025 vyžádáno Zuzka",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "máme SIPIQ",
|
||
"Illumninator status UC": "máme SIPIQ",
|
||
"Comment": "30APR2025 reminder, aby vyplnil feasibility dotazník\n29APR2025 reminder, aby vyplnil feasibility dotazník\n08APR2025 poslední pokus\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem 9APR2025 Svetlana ma meeting 15May, zeptá se",
|
||
"Společnost na CDA": "IKEM",
|
||
"PI Last Name": "Hucl/Drastich",
|
||
"PI First Name": "Tomáš/Pavel",
|
||
"Plné jméno": "prof. MUDr. Tomáš Hucl, Ph.D.\ndoc. MUDr. Pavel Drastich, Ph.D.",
|
||
"PI Email Address": "tomas.hucl@ikem.cz",
|
||
"PI Phone Number": "+420 236 052 600",
|
||
"PI Full Address": "IKEM",
|
||
"Primary Institution Name": "Ikem",
|
||
"Site Address": "Praha",
|
||
"Site City": "Praha"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Leksa"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "tip od svetlany https://www.gastromedic.cz/o-nas-a5",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_UdaEYElwWeMzunZ_b11cOvqU1TI0p3U_CGC_dBGlrGnvr8UPn0I&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Žaneta",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "26.5.2025 remotely",
|
||
"SIPIQ zajímavosti": "Nemá inkubátor, IGRA, EKG, mrazák -70",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 3 (3:0) / 2 (2:0)",
|
||
"Počet pacientů SQV": "CD 2 / UC 3 (naivní primárně)",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Recommended, ma jen naivni pacienty. CD 2, UC 3, vybaceni ma, chybi inkubator a centrifuga. Lekarna pobliz.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Nemá zájem",
|
||
"FINAL DECISION PRO ICONIC IBD": "Ano (10 z 10) - ale chybi centrifuga",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "Fully executed",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "SIPIQ hotov",
|
||
"Illumninator status UC": "SIPIQ hotov",
|
||
"Comment": "09APR2025 ozval se Dr. Leksa, mají zájem\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem + jestli ano, tak identifikovat PI 9APR2025 Svetlana zavolá a zeptá se",
|
||
"Společnost na CDA": "Gastromedic s.r.o.",
|
||
"PI Last Name": "Leksa",
|
||
"PI First Name": "Václav",
|
||
"Plné jméno": "MUDr. Václav Leksa",
|
||
"PI Email Address": "vaclav.leksa@seznam.cz",
|
||
"Site Address": "Pardubice"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Pešta"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Svetlana",
|
||
"EMA": "UC 1x po náboru a také 1x nábor pending u Bartoše",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"Comment": "26MAR2025 nemají pro studii prostor\n26MAR2025 email jestli zájem 9APR2025 Svetlana po Velikonocích meeting tak se jeste zeptá",
|
||
"Společnost na CDA": "Nemocnice Bulovka",
|
||
"PI Last Name": "Pešta",
|
||
"PI First Name": "Martin",
|
||
"Plné jméno": "MUDr. Martin Pešta",
|
||
"PI Email Address": "pestam@seznam.cz\nmartin.pesta@bulovka.cz",
|
||
"PI Phone Number": "+420 266 082 560",
|
||
"PI Full Address": "Bulovka",
|
||
"Primary Institution Name": "Bulovka",
|
||
"Site Address": "Praha",
|
||
"Site City": "Praha"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vyhnálek"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Svetlana namísto Vyhnálka??",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s dr Leksou",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_eXfhXjSPVkGRmE6_b11cOvqU1TI0p3U_CGC_gsUajdzMVzOKfw5&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "NE",
|
||
"SM": "Žaneta",
|
||
"SM poznámky": "6.5.2025 nepodařilo se mi dovolat,zkoušela jsem x krát. Poslala jsem upomínku emailem. 12.5.2025 nelze se dr. dovolat, ani na sekretariát.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "Jen pro info: Tady pracuje asi i dr Leksa, ale asi ok. Vedeno jako centrum biologické léčby s dr Leksou.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "25APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "25APR2025 SIPIQ odeslán",
|
||
"Comment": "30APR2025 reminder, aby vyplnil feasibility dotazník\n29APR2025 reminder, aby vyplnil feasibility dotazník\n11APR2025 opakování\n09APR2025 napsal jsem prim. PETR VYHNÁLEK",
|
||
"Společnost na CDA": "Nemocnice Pardubice",
|
||
"PI Last Name": "Vyhnálek",
|
||
"PI First Name": "Petr",
|
||
"Plné jméno": "MUDr. Petr Vyhnálek",
|
||
"PI Email Address": "petr.vyhnalek@nempk.cz",
|
||
"PI Full Address": "Nemocnice Pardubice",
|
||
"Primary Institution Name": "FN Pardubice",
|
||
"Site Address": "Pardubice",
|
||
"Site City": "Pardubice"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vanasek"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3008",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "2",
|
||
"Cn # sites": "2",
|
||
"Pr-Cn # Sites Open": "2",
|
||
"Cn F Site Open Exp": "2021-06-18 00:00:00",
|
||
"HA Init Appr Act": "2021-05-12 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "8",
|
||
"Cn # enrolled": "5",
|
||
"Cn # completed": "5",
|
||
"Cn # screen fail": "3",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - good performance, Panorama CD a Panorama UC (2 z1)",
|
||
"J&J studie": "Anthem",
|
||
"EMA": "UC1x nábor a 7x po náboru, CD 2x v naboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_1BzoQlyfQD4G2Tu_b11cOvqU1TI0p3U_CGC_fkiXZiDdEU2BSYj&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- Dr.Vaňásek souhlasí s provedení SQV při MV An them 15.5.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "15.5. v 15:30 \non-site",
|
||
"SIPIQ zajímavosti": "Zkrácená verze SIPIQ bez druhé části.",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 4 (1:3) / 4 (1:3)",
|
||
"Počet pacientů SQV": "UC- 5 screenovaní- 3 randomizovaní\nCD- 5 screenovaní- 3 randomizovaní",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "(nemají certifikovaný výškoměr), The SM recommends the site for participation based on potential subject population, correct staffing, space for\nconducting the study, qualification and previous experience in clinical trials (including UC a CD) and interest in\nthe proposed trial. Comments:The PI would welcome an increase in the amount of compensation:\n- for patients for endoscopy (to take into account 2 days- preparation and second day examination)\n- for accompanying a patient to a colonoscopy (they must take one day off from work)\n- and, if possible, if the travel costs took into account the patient's time spent at the site during patient visits\n(mainly during screening period and induction phase)\nPI confirmed that:\n- the site does not want to participate in the IUS sub-study\n- most patients will be able to use BYOD. He would like to receive a few handhelds on the site, for those who\ndon't have suitable phones.\nquestion raised during SQV:\n • If the termination of biological treatment was based on the refusal of the health insurance company to cover\nthe treatment even if the patient health status later worsened, the insurance company did not approve the\ncontinuation of biological treatment. Are these patients also excluded from the study?\n • During corticosteroids tapering if the patient's condition worsens, the physician should reinstitute\ncorticosteroids and/or report flare, or both?\n • Can flare be reported before complete discontinuation of corticosteroids?\nHowever, it must be taken into account that the site has a large number of studies and this may lead to\noverloading of site staffs. ají hodně studií, jsou hodně vytížení, ale hodně zkušení. Bude záležet na kompenzaci.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Má zájem o obě studie. Zkrácený SIPIQ, nevíme kolik pacientů. Mají hodně studií, jsou hodně vytížení, ale hodně zkušení. Bude záležet na kompenzaci.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO, ale pak už nenabízet jiné studie. Dělal Anthem. Povinný ultrazvuk nechtějí.",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "08APR2025 vyžádáno Zuzka",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 mluvil jsem s ním a udělá večer\n07apr2025 opakování emailu, ale nastavil jsem Illuminator approved for feasibility\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "HEPATO-GASTROENTEROLOGIE HK, s.r.o",
|
||
"PI Last Name": "Vanasek",
|
||
"PI First Name": "Tomas",
|
||
"Plné jméno": "MUDr. Tomáš Vaňásek, PhD.",
|
||
"PI Email Address": "tomas.vanasek@hepato-gastro.com",
|
||
"PI Phone Number": "603 545 009",
|
||
"PI Full Address": "tr. Edvarda Benese 1549/34,Poliklinika III.,,Hradec Kralove,",
|
||
"Primary Institution Name": "Hepato-gastroenterologie HK, s.r.o.",
|
||
"Primary Institution Phone Number": "420495218475",
|
||
"Site Address": "tr. Edvarda Benese 1549/34 Poliklinika III.",
|
||
"Site Address Line 2": "Poliklinika III.",
|
||
"Site City": "Hradec Kralove",
|
||
"Site Zip/Postal Code": "500 12",
|
||
"St # required subj": "1",
|
||
"St # screened": "1",
|
||
"St # enrolled": "1",
|
||
"St # completed": "1",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2021-03-22 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Šerclová"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3008",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "2",
|
||
"Cn # sites": "2",
|
||
"Pr-Cn # Sites Open": "2",
|
||
"Cn F Site Open Exp": "2021-06-18 00:00:00",
|
||
"HA Init Appr Act": "2021-05-12 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "8",
|
||
"Cn # enrolled": "5",
|
||
"Cn # completed": "5",
|
||
"Cn # screen fail": "3",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop - PI left the hospital. Good eprformance, KOL, Panorama",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s dr Matoušem",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_JLu3G9ijWqSTIuU_b11cOvqU1TI0p3U_CGC_Q0OKy7FBEjH1jqq&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Iveta",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "27.5. ve 14:30 on-site",
|
||
"SIPIQ zajímavosti": "IUS zájem má, ale DICOM nemá.",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. NA / 4 (2:2)",
|
||
"Počet pacientů SQV": "CD3-4",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Bohate zkusenosti. Zamysli se nad designem + odpoved na dotazy, spis pacienti po x lecbach. SC zaroven sekretarka. 2 comp studies konec cerven 2026. 3-4 pacienti. Na chirurgicke klinice IBD centra. Zajem i ostatni studie v kombinaci. Site is interested to be selected for conducting of ICONIC CRD study.\nThe study team has experience with clinical trials, the site has sufficient equipment and space for conducting\nthe study. All team members are qualified by certificates and experience for this study. The SM recommends\nthe site for participation based on potential subject population, correct staffing and equipment, previous\nexperience in clinical trials and interest in the proposed trial. Addtional comments: The site is not interested in performing IUS sub-study.\nPI- Dr. Serclova probably has CV on EUCTR template.\nPI was also informed about importance sign the following Form before initial study submission in case of\nselection:\nConflict of Interest and Centre Suitability.\nPI and SC was informed that all validation/calibration certificates for study equipment needs to be available\nbefore SIV.\n The site prefers patient compensation via sending payment on patient bank account.\nThe following questions/topics raised by PI during SQV a needs to be clarified by local or central team:\nPI has a fundamental question about the exclusion criterion: Is ileocecal resection - which is the most common\nCRD operation - considered a “colonic resection”? (Excl crit: History of extensive colonic resection (ie, <30 cm of\ncolon remaining) or colonic resection that could impair the use of disease severity assessments (eg. CDAI) to\nassess response to study intervention) • She has also comment related to design of the Induction study (1:1:1-\n30% chance placebo) and then in the Maintenance Icotrokinra responders were re-randomized to the 2:1\nplacebo arm, meaning that 30% of patients would be dropped from active treatment).",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Zájem jenom CD. 350 UC a z toho naivní 50 a 220 CD a z too navní 150.",
|
||
"FINAL DECISION PRO ICONIC IBD": "Ano, jedina, kdo ma zajem explicitne o CD",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "08APR2025 vyžádáno Zuzka",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "SIPIQ hotov",
|
||
"Illumninator status UC": "SIPIQ hotov",
|
||
"Comment": "29APR2025 reminder k vyplnění feasibility dotazníku\n07APR2025 pracuje na Vinohradech\n01APR2025 opakování dotazu\n26MAR2025 dotaz kde vlastně pracuje\n26MAR2025 má zájem\n26MAR2025 email jestli zájem - pak zjistíme kde vlastně je, ale pamatuji si, že do Anthem nechtěl, viděl jsem, že pracuje na Vinohradech jeden den, jako když neví, na kterou židli se posadit",
|
||
"Společnost na CDA": "Fakultní nemocnice Královské Vinohrady",
|
||
"PI Last Name": "Šerclová",
|
||
"PI First Name": "Zuzana",
|
||
"Plné jméno": "MUDr. Zuzana Šerclová",
|
||
"PI Email Address": "sercl@seznam.cz",
|
||
"PI Phone Number": "+420 602 158 805",
|
||
"Site Address": "K Nemocnici 1106 Chirurgicke oddeleni-gastroenterologie",
|
||
"Site Address Line 2": "Chirurgicke oddeleni-gastroenterologie",
|
||
"Site City": "Horovice",
|
||
"Site Zip/Postal Code": "268 31",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Lukas"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3008",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "2",
|
||
"Cn # sites": "2",
|
||
"Pr-Cn # Sites Open": "2",
|
||
"Cn F Site Open Exp": "2021-06-18 00:00:00",
|
||
"HA Init Appr Act": "2021-05-12 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "8",
|
||
"Cn # enrolled": "5",
|
||
"Cn # completed": "5",
|
||
"Cn # screen fail": "3",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - KOL, high performance, Panorama CD a panorama UC",
|
||
"J&J studie": "Astro (0), Duet CD (4), Duet UC (3), Anthem, Fuzion, Reason, Galaxy, Quasar",
|
||
"EMA": "UC3x nábor a 5x po náboru, Cd3x nabor a 3x po naboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_ZVTrPZp2ZfQUFaj_b11cOvqU1TI0p3U_CGC_4CZFthWoLDi6oW2&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Dan",
|
||
"SM poznámky": "2.5. - nikdo nezvedá, zkoušela jsem i SC Kalitzovou na mobil a také nebere. SC volala zpět. Prof. Lukáš v SanDiegu vrací ve čtvrtek.\n12.5. Hovor s SC Kalitzovou - Potencialne problem s prostory a pacienty, 13.3. behem rano znovu probere s PI Lukasem, 13.3. v 11:00 novy hovor s SC pro dohodu terminu SQV",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "On-site 26.5. v 9:30",
|
||
"SIPIQ zajímavosti": "více než 2 studie??? Zkrácená verze SIPIQ bez durhé části.",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 6 (2:4) / 8 (2:6)",
|
||
"Počet pacientů SQV": "3 rand. CD a 2 rand. UC",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "jméno, vybavení mají, zkušenosti, podstudii ano. Jsou si vědomi, že do insterních nenabrali, že jen do externích, tak by snad mohli. Nevýhoda hlavně pacienti, co 3 a více nedostatecná odpoved na biol. lecbu. meli bychom jim nabidnou alespon jednu ze tri studii, dalsi dve studie guselkumab ano, ale nemusi golimumab - to maji v CRO studii Duetu, 8 zascreenovali, ale udržel se jenom jeden pacient. takže JNJ4804 asi pro ně tolik ne, když už tak MAF kde guselkumab versus risankizumab. 3x UC a 3x CD. Budou zařazovat těžší pacienty. Vybavení mají.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Když obě tak s MAF, nikoliv JNJ4804 alespoň náš odhad podle zkušeností v Duetu (8 pacientů nabrali, jenom 1 se udržel). 5000 poacientů a 2500 na biologické léčbě.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO 9/10 ale nenabrali ve dvou internich studiích",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "08APR2025 vyžádáno Zuzka",
|
||
"LTM": "",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "30apr2025 reminder, aby vyplnil feasibility dotazník\n29APR2025 reminder aby vyplnil feasibility dotazník\nNenabral nic do Anthemu, nechceme, ICONIC je stejná molekula, design stejný, není důvod čekat, že teď nabere",
|
||
"Společnost na CDA": "Iscare a.s.",
|
||
"PI Last Name": "Lukas",
|
||
"PI First Name": "Milan",
|
||
"PI Email Address": "studie.lukas@email.cz",
|
||
"PI Phone Number": "+420 23 477 0299",
|
||
"PI Full Address": "Ceskomoravska 2510/19,8. patro,IBD a gastroenterologie,Praha 9,",
|
||
"Primary Institution Name": "ISCARE a.s.",
|
||
"Site Address": "Ceskomoravska 2510/19 8. patro IBD a gastroenterologie",
|
||
"Site Address Line 2": "8. patro",
|
||
"Site Address Line 3": "IBD a gastroenterologie",
|
||
"Site City": "Praha 9",
|
||
"Site Zip/Postal Code": "190 00",
|
||
"St # required subj": "6",
|
||
"St # screened": "7",
|
||
"St # enrolled": "4",
|
||
"St # completed": "4",
|
||
"St # screen fail": "3",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2021-03-22 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Douda"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3008",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "2",
|
||
"Cn # sites": "2",
|
||
"Pr-Cn # Sites Open": "2",
|
||
"Cn F Site Open Exp": "2021-06-18 00:00:00",
|
||
"HA Init Appr Act": "2021-05-12 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "8",
|
||
"Cn # enrolled": "5",
|
||
"Cn # completed": "5",
|
||
"Cn # screen fail": "3",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop - no active study - consider to add the site back during the next review as finally the site was added to REASON study in Oct 2023, Panorama CD",
|
||
"J&J studie": "Reason",
|
||
"EMA": "UC 1xnabor, CD 1x v naboru pod dr Melekem jan.melek@fnhk.cz",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"Comment": "04APR2025 nemají kapacitu\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"PI Last Name": "Douda",
|
||
"PI First Name": "Tomas",
|
||
"Plné jméno": "MUDr. Tomáš Douda, PhD.",
|
||
"PI Email Address": "tomas.douda@fnhk.cz",
|
||
"PI Phone Number": "+ 42 49 583 3818",
|
||
"PI Full Address": "Sokolska 581,II. interni gastroenterologicka klinika,,Hradec Kralove,",
|
||
"Primary Institution Name": "Fakultni nemocnice Hradec Kralove",
|
||
"Site Address": "Sokolska 581 II. interni gastroenterologicka klinika",
|
||
"Site Address Line 2": "II. interni gastroenterologicka klinika",
|
||
"Site City": "Hradec Kralove",
|
||
"Site Zip/Postal Code": "500 05",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hlavova"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Execution",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - low performance, Panorama",
|
||
"EMA": "CD 1 po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_HdK1o5mdbXoVvh8_b11cOvqU1TI0p3U_CGC_BFgyRyOI736CzOt&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5. tel.kontakt v 14h, neměla čas- volat po 16h- Dr.Hlavova telefon nezvedá (zkoušela jsem 2x na mobil + 2x na pevnou linku) . Volala zpět v 16:45. Byla 3 týdny pryč. Koukne se na to v týdnu 5.5. a dá vědět.\n6.5.- 18:30 poslala sms, že vyplnila SipIQ, domluvíme SQV\n7.5. 8:15- mobil nezvedá,volala zpět sama, zavolá cca 14-15h a domluvíme termín SQV",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "22.5. v 14h \non-site \nDr.Hlavová chce u selekce celý tým = +4CDA",
|
||
"SIPIQ zajímavosti": "není centrum biologické léčby a uvádí IR což i uvádí v dotazníku, že léčí pacienty na biologickou léčbu víc než naivní\n26May25 LP- dle PI mají centrum biol.léčby",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 2 (1:1) / 2 (1:1)",
|
||
"Počet pacientů SQV": "UC- 2 randomizovaní\nCD- 2 randomizovaní\nbudou screenovat dokud nezařadí 2 pacienty, mají jak naivní, tak po selhání na ADT",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "The SM recommends the site for participation based on potential subject population, correct staffing, space for\nconducting the study, qualification and previous experience in clinical trials (including UC a CD) and interest in\nthe proposed trial.\nThe site does not have a study coordinator, this role will be done by the PI. The PI mentioned that she would\nneed help setting up access to Vendor's systems.\nAppropriate site staff should complete IATA training if a site is selected. Additional comments: The site has preliminary interest in the IUS sub-study, but would like to know more details - what are the\nrequirements, the procedure for ultrasound recording, and how and where to record. IUS will be done by PI or\nsub-investigator.\nPI confirmed that most patients will be able to use BYOD. She would like to receive a few handhelds on the site,\nfor those who don't have suitable phones. Jen tuto studii, nemá SC, dá jenom 2 randomizované pacienty.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Nemá zájem o JNJ4804. Jen tuto studii, nemá SC, dá jenom 2 randomizované pacienty.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO, jenom nezařadí více pacientů, ale mohl by zařadit Falc",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "08APR2025 vyžádáno Zuzka",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "30APR2025 reminder, aby vyplnila feasibility dotazník\n29APR2025 reminder by vyplnila feasibility dotazník\n04APR2025 má zájem\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "Oblastni nemocnice Kladno a.s.",
|
||
"PI Last Name": "Hlavova",
|
||
"PI First Name": "Helena",
|
||
"PI Email Address": "hhlavova@atlas.cz",
|
||
"PI Phone Number": "312 606 289 nebo linka 760, 602 204 273",
|
||
"PI Full Address": "Vancurova 1548,,,Kladno,",
|
||
"Primary Institution Name": "Oblastni nemocnice Kladno a.s.",
|
||
"Primary Institution Phone Number": "420602303112",
|
||
"Site Address": "Vancurova 1548",
|
||
"Site City": "Kladno",
|
||
"Site Zip/Postal Code": "27259",
|
||
"St # required subj": "2",
|
||
"St # screened": "1",
|
||
"St # enrolled": "1",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2021-12-09 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Stepek"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Execution",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - high performance, Panorama CD a Panorama UC 2 ze 4",
|
||
"J&J studie": "Due CD a UC (?), Graviti",
|
||
"EMA": "UC5x nábor a 6x po náboru, CD 1 v náboru a 1 v náboru u Hegyi",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_RYae4Pghd19RhPz_b11cOvqU1TI0p3U_CGC_UviLrNeD52rxvhz&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- 14h nikdo nebere, 15h- byl na cestě v autě- slíbil, že vyplní SipIQ zítra (v So 3.5.) a poté domluvíme termín SQV. 3.5. vyplnil SipIQ, čeká na CDA.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "13.5. v 18:30 \non-site",
|
||
"SIPIQ zajímavosti": "Nic, co by vybočovalo",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol???? 4 (2:2) / 5 (2:3)",
|
||
"Počet pacientů SQV": "CD- 5 screenovaní- 3 randomizovaní",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "The SM recommends the site for participation based on potential subject population, correct staffing, space for\nconducting the study, qualification and previous experience in clinical trials (including UC a CD) and interest in\nthe proposed trial. Additonal comments: PI confirmed:\n- that he is not interested in IUS sub-study.\n- patients receiving biologic treatment at this site were enrolled in clinical trials. Site is not biological treatment\ncenter.\n - most patients will be able to use BYOD. He would like to receive a few handhelds on the site, for those who\ndon't have suitable phones. Přístroje má. Měl jít do Anthemu, ale tím, že nebyl budget, tak to neklaplo. Teoreticky by mohl do další studie. Asi bude ve smlouvě cap na počet pacientu (5) a pak pisemné potvrzeni o dalsi pacienty. Snad i zvládne s Ulbrychem v Brně. Pacienti se selháním na biol lecbu jenom ve studiích.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Má zájem o obě studie.100 pacientů CD 50:50 a 150 pacientů UC 100:50 ročně.Měl jít do Anthemu, ale tím, že nebyl budget, tak to neklaplo. Teoreticky by mohl do další studie. Asi bude ve smlouvě cap na počet pacientu (5) a pak pisemné potvrzeni o dalsi pacienty. Snad i zvládne s Ulbrychem v Brně. Pacienti se selháním na biol lecbu jenom ve studiích.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "Fully executed",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "05MAY2025 SIPIQ vyplněný",
|
||
"Illumninator status UC": "05MAY2025 SIPIQ vyplněný",
|
||
"Comment": "29APR2025 omylem jsem mu SIPIq neposlal, zjistil jsem to dnes, posílám\n01APR2025 má zájem, poslat SIPIQ\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "Vojenská nemocnice Brno",
|
||
"PI Last Name": "Stepek",
|
||
"PI First Name": "David",
|
||
"PI Email Address": "dstepek@vnbrno.cz",
|
||
"PI Phone Number": "+420 973 445 401",
|
||
"PI Full Address": "Zabrdovicka 3,,,Brno,",
|
||
"Primary Institution Name": "Fakultni nemocnice Brno Vojenská nemocnice Brno",
|
||
"Primary Institution Phone Number": "+420532232265000 0 000 000 000",
|
||
"Site Address": "Zabrdovicka 3",
|
||
"Site City": "Brno",
|
||
"Site Zip/Postal Code": "636 00",
|
||
"St # required subj": "3",
|
||
"St # screened": "5",
|
||
"St # enrolled": "5",
|
||
"St # completed": "2",
|
||
"St # screen fail": "0",
|
||
"St # early term": "1",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2021-10-29 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Smid"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - good performance, Panorama CD, Panorama UC 0 z 1 pacienta",
|
||
"J&J studie": "Astro (0)",
|
||
"EMA": "UC 1x po náboru (kolegyně Mayerová a Veberová po 1 studii v náboru), CD 1x po náboru (a Veberová také 1x po náboru)",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_oikvDetURD8tHn6_b11cOvqU1TI0p3U_CGC_rg13MPWrUyFQt9M&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "NE",
|
||
"SM": "Žaneta",
|
||
"SM poznámky": "6.5.2025 dovolala jsem se, slíbil že co nejdříve vyplní. Příjemný pan doktor :)12.5.2025 opět jsem dr. volala, slíbil, že vyplní do termínu. 14.5.2025 s dr. jsem mluvila, říkal, že se na dotazník znovu podívá, ale stále nic. Nejspíš bez zájmu. Už ho nebudu kontaktovat, psala a volala jsem mu x krát.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "30apr2025 připomínka, aby dokončil feasibility dotazník\n29APR2025 začal vyplňovat, ale moc daleko ne, poslal jsem mu připomínku\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "Synexus",
|
||
"PI Last Name": "Smid",
|
||
"PI First Name": "Vaclav",
|
||
"PI Email Address": "venca.smid@gmail.com",
|
||
"PI Phone Number": "+42 721 944 429",
|
||
"PI Full Address": "Charles Square 2097/10,,,Prague 2,",
|
||
"Primary Institution Name": "Synexus Czech s.r.o.",
|
||
"Site Address": "Charles Square 2097/10",
|
||
"Site City": "Prague 2",
|
||
"Site Zip/Postal Code": "120 00",
|
||
"St # required subj": "0",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2021-11-03 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Jelinek"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama",
|
||
"EMA": "CD 1 po náboru.UC2x nábor a 2x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_L5prMyVze5GpH2o_b11cOvqU1TI0p3U_CGC_t4Ulhk5PFCocIDX&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- dotazník vyplňuje Kateřina Urbánková (katerina.urbankova@crc-cz.com), slíbila, že dnes dovyplní. Adresa centra potvrzena telefonicky.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "12.5. v 10:00 \non-site",
|
||
"SIPIQ zajímavosti": "Nevychází počty, asi myslel 4 do UC a 4 do CD?:-) Nemá zkušenost s dotazníky, C-SSRS, nemá mrazák -70",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol??? 2 (2:2) / 2 (2:2)",
|
||
"Počet pacientů SQV": "2-3 screening/ 1-2 randomizovaní (pouze naivní pacienti) na kazdou studii",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "SM partially recommends site.\nIt is small site- PI predicted 1-2 randomized patients for UC and 1-2 randomized patients for CD.\nThe Electronic source medical records and study electronic records needs to be unified at the site (detailed\ninformation- under B. CRF, EDC Review, Source Data, Section #2 Access to medical records verified?\nPI is interested in the study (including the IUS sub-study) and confirms that he has sufficient time to conduct the\nstudy.\nThere are currently 2 ongoing studies- one for UC and one for CD.\nThe study team has experience with clinical trials, the site has sufficient equipment and space for conducting\nthe study.\nPI has been conducting studies for 8 years. All team members are qualified by certificates and experience for\nthis study. Addtional comments: PI confirmed that some patients will be able to use BYOD. He would like to receive a few handhelds on the site,\nfor those who don't have suitable phones. Male mnozstvi pacientu, Spise 1 pacient, zajem o ultrazvuk",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Má zájem o JNJ4804 studii, ale ty počty nevychází. Zadáno 110 CD pacientů, 0 UC a navní 30 CD a naivní 80 UC. Není centrum biol lecby ne? Male mnozstvi pacientu, MAX 2",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO ale 1 pacient",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "Fully executed",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 začal vyplňovat a skončil na otázce ultrazvuku, tak mu píšu, že to je volitelná substudie\n08APR2025 má zájem\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "Gastro JeKa,s.r.o. (Klatovy)",
|
||
"PI Last Name": "Jelinek",
|
||
"PI First Name": "Ondrej",
|
||
"PI Email Address": "ondra.jelinek@cmail.cz",
|
||
"PI Phone Number": "+420 37 632 0831",
|
||
"PI Full Address": "Krejciho nabrezi 914/4,,,Klatovy,",
|
||
"Primary Institution Name": "GASTRO JeKa, s.r.o.",
|
||
"Site Address": "Krejciho nabrezi 914/4",
|
||
"Site City": "Klatovy",
|
||
"Site Zip/Postal Code": "339 01",
|
||
"St # required subj": "0",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Matous"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Completed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - good performance, Panorama CD a UC (tam v Axonu Ostrovského 3x)",
|
||
"J&J studie": "Astro (2), Graviti, Quasar",
|
||
"EMA": "UC 1x po náboru ale v rámci Axonu Sevce Matouse, CD 2x v níboru a 3 po náboru v Axonu Ostrovského",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_KOpXToAxvPBc3QA_b11cOvqU1TI0p3U_CGC_Jo6LndurqvWLf5W&_g_=g",
|
||
"SM": "Ivetka",
|
||
"SM poznámky": "Dr. Matous vyplnil 5.5. SIPIQ, zájem má, poté CDA a předběžně stanoven již termín SQV",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "21.5. ve 14:00 on-site",
|
||
"SIPIQ zajímavosti": "Nemá zkušenosti s fistula assessment? Jeden z mála, není omyl yrovna tady?",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol??? 5 (3:2) / 4 (2:2)",
|
||
"Počet pacientů SQV": "CD 4 a UC 5",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Potencial ma, vsechno vybaveni - urcite ano. Do CD 4, a UC 5. Selhane pacienty referuje z FNKV.Dalsi studii v kombinaci zajem o UC. Site is very interested to be selected for conducting of both ICONIC IBD studies (UC and CRD):\nThe study team has experience with clinical trials, the site has sufficient equipment and space for conducting\nthe study. All team members are qualified by certificates and experience for this study. The SM recommends\nthe site for participation based on potential subject population, correct staffing and equipment, previous\nexperience in clinical trials and interest in the proposed trial.Additonal comments: PI-Dr. Jan Matous and SI-Dr. Zdena Zadorova are performing endoscopy.\nThe site does not have adolescent patients for ulcerative colitis study; the site addresses only for adult patients\nwith gastrointestinal diseases..The site prefers patient travel reimbursement via direct payment on bank\naccount or cash payment rounded to the nearest hundred. Sute has also experience with payment system\nSCAUT or Clicard.\nPI- Dr. Matous probably has CV on EUCTR template.\nPI was also informed about importance sign the following Form before initial study submission incase of\nselection: Conflict of Interest and Centre Suitability.\nPI was informed that all validation/calibration certificates for study equipment needs to be available before SIV.\nDuring SQV was also present SI-Dr. Martin Vallisch-Head of Clinical Research Axon Clinical.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Zájem jen o JNJ4804 UC. počty nevychází 100 CD (40 naivní a 25) a 70 UC (30:25).",
|
||
"FINAL DECISION PRO ICONIC IBD": "Urcite Ano",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "Fully executed",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "05MAY2025 SIPIQ znovu přeposlán Wallisch, Matouš\n30APR2025 připomínka, aby vyplnil SIPIQ\n29APR2025 připomínka k vyplnění feasibility dotazníku\n04APR2025 mají zájem\n01APR2025 opakování emailu\n26MAR2025 email jestli zájem",
|
||
"Společnost na CDA": "Axon Clinical",
|
||
"PI Last Name": "Matous",
|
||
"PI First Name": "Jan",
|
||
"PI Email Address": "jmatous@gmail.com\ndo komunikácie pridávať aj SC/zuzana.zavorkova@axon-clinical.com",
|
||
"PI Phone Number": "+420 776 767 590",
|
||
"PI Full Address": "?",
|
||
"Primary Institution Name": "Fakultni nemocnice Kralovske Vinohrady",
|
||
"Primary Institution Phone Number": "+420267163531",
|
||
"Site Address": "Šrobárova 50",
|
||
"Site City": "Praha 10",
|
||
"Site Zip/Postal Code": "100 34",
|
||
"St # required subj": "3",
|
||
"St # screened": "4",
|
||
"St # enrolled": "3",
|
||
"St # completed": "2",
|
||
"St # screen fail": "1",
|
||
"St # early term": "1",
|
||
"St # disc treatm": "3",
|
||
"St Qualified Act": "2021-11-17 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Pumprla jr."
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Panorama",
|
||
"EMA": "UC5x nábor a 2x po náboru a CD 1x v náboru a 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "01APR2025 Vilu zdraví již má Helena\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Pumprla jr.",
|
||
"PI First Name": "Jiri",
|
||
"PI Email Address": "pumprlajr@vilazdravi.cz",
|
||
"PI Phone Number": "+420 72 433 9851",
|
||
"PI Full Address": "Domovina 2,,,Olomouc,",
|
||
"Primary Institution Name": "PreventaMed, s.r.o.",
|
||
"Primary Institution Phone Number": "+420585225504",
|
||
"Site Address": "Domovina 2",
|
||
"Site City": "Olomouc",
|
||
"Site Zip/Postal Code": "77900",
|
||
"St # required subj": "4",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Konecny"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_mylCjrFEKVPL9J5_b11cOvqU1TI0p3U_CGC_4fGH7Y7sbCgs7n9&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Vlaďka",
|
||
"SM poznámky": "14.05. jsem volala, nebere, zkusim znovu zitra",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "27.5. v 15:00 on-site",
|
||
"SIPIQ zajímavosti": "Nemá zkušenost s C-SSR a IGRA testováním, nevychází počty",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol??? 8 (6:2) / 10 (5:3)\ncentrum nebiol, ale doktor ma pacienty take z FNOL",
|
||
"Počet pacientů SQV": "UC (random 5; 2 naive vs. 3 ADT-IR)\nCD (random 6; 2 naive vs. 4 ADT-IR)",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Mozny problém pro pacienty placebo. Kolonoskopie na konci indukce, maintenance a screeningu je celkem dost. Pacineti na biol lecbe jsou z nemocnice v Olomouci, mel by k nim plnou dokumentaci. Je tam po, ut a ct a SI Baca st a pa, kazdy by mel sve pacienty. za poslednich 5 let studii nemeli. Dáme 4 pacienti do obou studií s ohledem na dalsi studie. Spíše pacienti biol lecby. Nemá inkubator (centrála dodá) a centrifugu (nechteji si koupit) a min/max teplomer. rtg v budove. denní vyplnovaní deniku jsme optimisti, pár otázek. Archiv ve sklepe doma. Lokální laborka není zasmluvněna (pak vyžádat na žádance a faktury). Léky v lékárně, je mozné zasmluvnit od nás. Mensi tym, SC zena PI.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Zájem obě studie, počty pacierntů zvláštní, ale asi myslel převážně 50-60 UC i CD (zadal advanced therapy a naivní jednotky) - to z nemocnice Olomouc tak to by slo.. Asi 15 naivni, ostantí biol a jen 10 procent 3 a více selhání.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO",
|
||
"Adolescenti": "ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 připomínka, aby vyplnil feasibility dotazník\nmá zájem\n09APR2024 email jestli zájem\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "MUDr. Michal Konečný, Ph.D., s.r.o.",
|
||
"PI Last Name": "Konecny",
|
||
"PI First Name": "Michal",
|
||
"PI Email Address": "konecnymi@seznam.cz",
|
||
"PI Phone Number": "+420 581 201 691",
|
||
"PI Full Address": "Budovatelu 197/6,,,Prerov,",
|
||
"Primary Institution Name": "MUDr. Michal Konecny, Ph.D. s.r.o.",
|
||
"Site Address": "Budovatelu 197/6",
|
||
"Site City": "Prerov",
|
||
"Site Zip/Postal Code": "750 02",
|
||
"St # required subj": "3",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Peterka"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Execution",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - high performance, Panorama CD a Panorama UC",
|
||
"J&J studie": "Anthem, Graviti",
|
||
"EMA": "CD 1 v náboru a 2 ukončený nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"Comment": "Toto centrum ne, to je stroj na major protocol deviations\nSice nabral, ale je strasne narocny",
|
||
"PI Last Name": "Peterka",
|
||
"PI First Name": "Martin",
|
||
"PI Email Address": "peterka.studie@seznam.cz",
|
||
"PI Phone Number": "+420 312 575 338",
|
||
"PI Full Address": "Politickych veznu 576,,,Slany,",
|
||
"Primary Institution Name": "Nemocnice Slany",
|
||
"Site Address": "Politickych veznu 576",
|
||
"Site City": "Slany",
|
||
"Site Zip/Postal Code": "274 01",
|
||
"St # required subj": "2",
|
||
"St # screened": "8",
|
||
"St # enrolled": "5",
|
||
"St # completed": "3",
|
||
"St # screen fail": "3",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "3",
|
||
"St Qualified Act": "2022-02-04 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Kojecky"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop - no active studies and no plan to involve in the future, PanoramaCD a Panorama UC not selected",
|
||
"EMA": "UC 1x nábor penbding, CD 1y po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"LTM": "Vlado",
|
||
"Comment": "02apr2025 obsazeno, nemají kapacitu\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Kojecky",
|
||
"PI First Name": "Vladimir",
|
||
"PI Email Address": "kojecky@bnzlin.cz",
|
||
"PI Phone Number": "+420 577 552 510",
|
||
"PI Full Address": "Havlickovo nabrezi 600,,,Zlin,",
|
||
"Primary Institution Name": "Krajska nemocnice T. Bati, a.s.",
|
||
"Primary Institution Phone Number": "+4205775531880000 000 000 000",
|
||
"Site Address": "Havlickovo nabrezi 600",
|
||
"Site City": "Zlin",
|
||
"Site Zip/Postal Code": "76275",
|
||
"St # required subj": "2",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2022-02-07 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Ulbrych"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop, Panorama CD - high performance, Panorama UC not selected",
|
||
"EMA": "UC5x nábor a 2x po náboru. CD 3 v naboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_Yd3C1WQBzbByL2Y_b11cOvqU1TI0p3U_CGC_i6ePl2ietFOcSy4&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Helena",
|
||
"SM poznámky": "16.5. , ale zřejmě virtuálně, je dost zaneprázdněný do konce května",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "16.5. v 9h remote",
|
||
"SIPIQ zajímavosti": "Nemá mrazák -70, jinak nic co by vybocovalo",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 2 (1:1) / 2 (1:1)",
|
||
"Počet pacientů SQV": "2 a 2. hodně studií.",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "SM recommends site.It is small site- PI predicted 2 randomized patients for UC and 2 randomized patients for\nCD.PI is interested in the study (including the IUS sub-study) and confirms that he has sufficient time to conduct\nthestudy.There are currently 2 ongoing studies- one for UC and one for CD.The study team has experience with\nclinical trials, the site has sufficient equipment and space for conducting the study.PI has vast experience in\nconducting studies within past years. All team members are qualified by certificates and experience for this\nstudy.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Zájem jen o JNJ4804 UC. asi 50 UC (20:30).",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO urcite",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "CDA fully signed PI varianta",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "approved for feasibility",
|
||
"Illumninator status UC": "approved for feasibility",
|
||
"Comment": "ano muzeme zaslat feasky na surgalclinic",
|
||
"Společnost na CDA": "Surgal Clinic (Brno)",
|
||
"PI Last Name": "Ulbrych",
|
||
"PI First Name": "Jan",
|
||
"PI Email Address": "jan.ulbrych@fnusa.cz - nefunguje, julbrych@vnbrno.cz - nereaguje; ulbrych.jan@surgalclinic.cz - sem mame poslat feasku",
|
||
"PI Phone Number": "+420 543 182 418",
|
||
"Primary Institution Name": "Surgal Clinic",
|
||
"Site Address Line 2": "II. interni klinika - ambul. odd-GEO",
|
||
"Site City": "Brno",
|
||
"St # required subj": "2",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Bortlik"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3004",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "5",
|
||
"Pr-Cn # Sites Open": "5",
|
||
"Cn F Site Open Exp": "2022-09-02 00:00:00",
|
||
"HA Init Appr Act": "2022-04-08 00:00:00",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "18",
|
||
"Cn # enrolled": "14",
|
||
"Cn # completed": "7",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "2",
|
||
"Cn # disc treatm": "6",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - KOL, high performance, PanoramaCD a Panorama UC",
|
||
"J&J studie": "Astro (3), Anthem, Fuzion, Reason, Galaxy, Quasar",
|
||
"EMA": "UC 2x nábor, 5x po náboru, CD 2x nábor a 3x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_sHHVj5wzqP6OdLt_b11cOvqU1TI0p3U_CGC_JwriqHMh3ZC92hz&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "2.5.- 14h- primář na vizitě volat po 14:30 na uvedené lince nebo na konci \"00\", stále je na vizitě, volat 14:50, poslat info na mbortlik@seznam.cz, volat v 6.5. úterý 14:45. \n6.5.- ještě se nestihl podívat, slíbil, že zkoukne do konce týdne, volat v Út 13.5. mezi 14-15h (od 15h má vizitu) a případně domluvit SQV",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "20.5. v 14h \nzměna termínu (PI zapomněl a nemá čas) na \n21.5. v 15:30\nremote",
|
||
"SIPIQ zajímavosti": "Simplified SIPIQ",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 6 (2:4) / 8 (2:6)",
|
||
"Počet pacientů SQV": "UC: 8-10 screenovaní- 5 randomizovaní\nCD: 8-10 screenovaní- 5 randomizovaní\n(pacienti naivní / ADT v poměru 1:1)\npočty bych brala s rezervou do ATHEMU skreenoval 3 a zařadil 1 pacienta",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "The SM recommends the site for participation based on potential subject population, correct staffing, space for\nconducting the study, qualification and previous experience in clinical trials (including UC a CD) and interest in\nthe proposed trial. Zkušenosti s Anthem, osvedceny, SC má, vybavení má.\nAdditional comments: Site would like to participate in IUS sub-study.\nPI confirmed that most patients will be able to use BYOD. He would like to receive a few handhelds on the site,\nfor those who don't have suitable phones.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Nemá zájem o JNJ4804",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "17APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "17APR2025 SIPIQ odeslán",
|
||
"Comment": "29AP2025 reminder k vyplěnní dotazníku\n07APR2025 ještě nemám odpověď, ale nastavil jsem Illuminator, že approved for feasibility\n04APR2025 email a tel, navíc je to IBD centrum pro děti, takže nabídnuto i UC adolescentů\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Nemocnice České Budějovice",
|
||
"PI Last Name": "Bortlik",
|
||
"PI First Name": "Martin",
|
||
"PI Email Address": "mbortlik@seznam.cz",
|
||
"PI Phone Number": "+42 023 477 0231",
|
||
"PI Full Address": "B. Nemcove 585/54,,Gastroenterologické odd.,Ceske Budejovice,",
|
||
"Primary Institution Name": "Nemocnice Ceske Budejovice a s",
|
||
"Site Address": "B. Nemcove 585/54 Gastroenterologické odd.",
|
||
"Site Address Line 3": "Gastroenterologické odd.",
|
||
"Site City": "Ceske Budejovice",
|
||
"Site Zip/Postal Code": "37001",
|
||
"St # required subj": "1",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2022-10-17 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Konecny"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "78934804CRD2001",
|
||
"Strategic Priority": "4 - Priority",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "4",
|
||
"Cn # sites": "3",
|
||
"Pr-Cn # Sites Open": "3",
|
||
"Cn F Site Open Exp": "2023-02-24 00:00:00",
|
||
"HA Init Appr Act": "2022-12-22 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "11",
|
||
"Cn # enrolled": "6",
|
||
"Cn # completed": "3",
|
||
"Cn # screen fail": "5",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "3",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - low performance,PanoramaCD, Panorama UC Cancelled",
|
||
"J&J studie": "Due CD a UC (?)",
|
||
"EMA": "UC 1x po náboru, CD 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano s doc Zbořilem",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_nrPn4Id1YNfdkow_b11cOvqU1TI0p3U_CGC_1w3BUAWixvkod2n&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Žaneta",
|
||
"SM poznámky": "Ozval se MUDr. Štefan Konečný, že mu doc.Dolina předal studii a dr. Konečný bude PI.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "22.5.2025 remotely",
|
||
"SIPIQ zajímavosti": "Nevychází počty, nemá zkušenost s dotazníky, s c-ssrs, nemá mrazák. Zájem o další dvě studie UC i CD",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 5 (5:5) / 10 (8:8)",
|
||
"Počet pacientů SQV": "CD 5 / UC 3",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Zkuseni, maji vybaveni. SC sikovna. Recommended 100%, he site is well experienced in clinical trial studies. They have adequate number of suitable patients. They have\nexperienced site staff and required eqipoment.\n PI is very interested in the proposed trials.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Pod Dolinou. Mají zájem oboje. Počty se mi zdají vysoké, když max 30 pacientů rocně podle SIPIQ (zadáno zvlaštně)",
|
||
"FINAL DECISION PRO ICONIC IBD": "Ano, 10 z 10",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "Fully executed (master agreement)",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "02MAR2025 SIPIQ vyplněný",
|
||
"Illumninator status UC": "02MAR2025 SIPIQ vyplněný",
|
||
"Comment": "29APR2025 reminder, aby vyplnil dotazník\n22APR2025 volal jsem mu a chce poslat feasibilitu\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Fakultní nemocnice Brno",
|
||
"PI Last Name": "Konecny",
|
||
"PI First Name": "Stefan",
|
||
"PI Email Address": "konecny.stefan@fnbrno.cz",
|
||
"PI Phone Number": "+420 53 223 3500",
|
||
"PI Full Address": "Jihlavska 20,,,BRNO,",
|
||
"Primary Institution Name": "Fakultni nemocnice Brno",
|
||
"Primary Institution Phone Number": "+420532232265000 0 000 000 000",
|
||
"Site Address": "Jihlavska 20",
|
||
"Site City": "BRNO",
|
||
"Site Zip/Postal Code": "625 00",
|
||
"St # required subj": "3",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2022-03-02 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Tichy"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "78934804CRD2001",
|
||
"Strategic Priority": "4 - Priority",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "4",
|
||
"Cn # sites": "3",
|
||
"Pr-Cn # Sites Open": "3",
|
||
"Cn F Site Open Exp": "2023-02-24 00:00:00",
|
||
"HA Init Appr Act": "2022-12-22 00:00:00",
|
||
"Cn # expected subj": "12",
|
||
"Cn # screened": "11",
|
||
"Cn # enrolled": "6",
|
||
"Cn # completed": "3",
|
||
"Cn # screen fail": "5",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "3",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop - no active study, no plan to include in the future, Panorama",
|
||
"J&J studie": "Due CD",
|
||
"EMA": "UC 1 po náboru, CD 1 po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano s dr Stehlíkem",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_2okJD2ie1iJwuSo_b11cOvqU1TI0p3U_CGC_HaqJssz4XfIqpOT&_g_=g",
|
||
"SM": "Ivetka",
|
||
"SM poznámky": "zastihla jsem ho v autě, přislíbil že se na dotazník podívá. Již při vyplňování dotazníku dosti negativistický, vše špatně. Potenciálně zájem o CD, ale ne 2b studii-PK nepokryje",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 začal vyplńovat, moc daleko se nedostal, poslal jsem mu reminder\n01APR2025 mají zájem, poslat SIPIQ\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Krajská nemocnice Ústí nad Labem",
|
||
"PI Last Name": "Tichy",
|
||
"PI First Name": "Michal",
|
||
"PI Email Address": "michal.tichy@kzcr.eu",
|
||
"PI Phone Number": "+42 047 711 2450",
|
||
"PI Full Address": "Secialni Pece 3316/12a,,,Usti nad Labem,",
|
||
"Primary Institution Name": "Detska klinika Masarykovy nemocnice v Usti nad Labem",
|
||
"Site Address": "Secialni Pece 3316/12a",
|
||
"Site City": "Usti nad Labem",
|
||
"Site Zip/Postal Code": "401 11",
|
||
"St # required subj": "4",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2022-01-19 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Volfova"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3005",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-07-03 00:00:00",
|
||
"HA Init Appr Act": "2018-05-03 00:00:00",
|
||
"Cn # expected subj": "20",
|
||
"Cn # screened": "28",
|
||
"Cn # enrolled": "24",
|
||
"Cn # completed": "19",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "5",
|
||
"Cn # disc treatm": "13",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Zuzka - good performance, Panorama CD a Panorama UC (9 z 5)",
|
||
"J&J studie": "Reason, Galaxy",
|
||
"EMA": "UC3x nábor a 1x po náboru, CD 2x v naboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano s dr Vaňáskem",
|
||
"LTM": "Helena",
|
||
"Comment": "toto centrum ne, je to Vaňásek",
|
||
"PI Last Name": "Volfova",
|
||
"PI First Name": "Miroslava",
|
||
"PI Email Address": "miroslava.volfova@hepato-gastro.com",
|
||
"PI Phone Number": "+42 49 521 8475",
|
||
"PI Full Address": "Edvarda Benese 1549/34,,,Hradec Kralove,Hradec Kralove",
|
||
"Primary Institution Name": "Hepato-gastroenterologie HK, s.r.o.",
|
||
"Primary Institution Phone Number": "420495218475",
|
||
"Site Address": "Edvarda Benese 1549/34",
|
||
"Site City": "Hradec Kralove",
|
||
"Site Zip/Postal Code": "500 12",
|
||
"St # required subj": "5",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2018-01-29 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Suchanek"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3005",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-07-03 00:00:00",
|
||
"HA Init Appr Act": "2018-05-03 00:00:00",
|
||
"Cn # expected subj": "20",
|
||
"Cn # screened": "28",
|
||
"Cn # enrolled": "24",
|
||
"Cn # completed": "19",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "5",
|
||
"Cn # disc treatm": "13",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Panorama - low performance 1x",
|
||
"EMA": "UC 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_KitXpnqi5tlpMJi_b11cOvqU1TI0p3U_CGC_qIp0SB3UZWwJ2Jk&_g_=g",
|
||
"SM": "Dan",
|
||
"SM poznámky": "PI nedostupny, \ntelefonicky s SC Hana Kubů,\npředá info PI, ale s velkou \npravděpodobností nebudou \nshopni z kapacitních důvodů",
|
||
"SIPIQ zajímavosti": "Podle Dana když 13 May nevyplněno, nemají zájem",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 připomínka, aby vyplnil SIPIQ\nNevím jestli má zájem, ale SIPIQ jsem mu poslal\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Mediendo",
|
||
"PI Last Name": "Suchanek",
|
||
"PI First Name": "Stepan",
|
||
"PI Email Address": "stepan.suchanek@mediendo.cz",
|
||
"PI Phone Number": "+420 273 139 861",
|
||
"PI Full Address": "Thámova 183/13,,,Prague,",
|
||
"Primary Institution Name": "MEDIENDO s.r.o.",
|
||
"Site Address": "Thámova 183/13",
|
||
"Site City": "Prague",
|
||
"Site Zip/Postal Code": "186 00",
|
||
"St # required subj": "8",
|
||
"St # screened": "1",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "1",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2018-01-29 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Jungwirthova"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1275CRD3005",
|
||
"Strategic Priority": "Not Applicable",
|
||
"Pr Status CTMS": "Closed",
|
||
"Pr-Cn Status": "Closed",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-07-03 00:00:00",
|
||
"HA Init Appr Act": "2018-05-03 00:00:00",
|
||
"Cn # expected subj": "20",
|
||
"Cn # screened": "28",
|
||
"Cn # enrolled": "24",
|
||
"Cn # completed": "19",
|
||
"Cn # screen fail": "4",
|
||
"Cn # early term": "5",
|
||
"Cn # disc treatm": "13",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama - low performance 1x",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_avdLbAcIjJpXowp_b11cOvqU1TI0p3U_CGC_c4R7v1tpBcuwRwg&_g_=g",
|
||
"SM": "Ivetka",
|
||
"SM poznámky": "Dr. Junqwirtová telefonicky slíbila 5.5. vyplnit SIPIQ asap, zájem má velký, poté CDA a předběžně stanoven již termín SQV. Opet upomenuta 7.5.25",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "20. 5. v 10:00 on-site",
|
||
"SIPIQ zajímavosti": "nemá inkubátor, igra, rtg hrudníku",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 3 (3:0) / 2 (2:0)",
|
||
"Počet pacientů SQV": "2 na UC a 2 na CD",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Hlavne naivni pacienty. Nemaji extra velkou zkusenost se studiemi, posledni pred COVIDEM, SI jeji syn - licenci na endoskopii. Jen 1 famaceut. Reseni - najit jinou lekarnu s 2 farmaceuty. Nemaji zadne kalibrace, validace, ochotni si nakoupit pristroje. The study team has experience with a few clinical trials, the site has space for conducting the study, hopefully\nsufficient equipment (instead of Stadiometer for measuring height, Incubator for -TBC test) but without valid\ncertificates-site is willing to buy new ones or order to safety BTK check in order to met study equipment additional comments: During SQV was present other JJ SM-Agnessa Ruz Kajtarova.\nDuring SQV was also present SC-Milan Hanuska and SI-Jiri Jungwirt.\nThe site interested in performing IUS sub-study; both PI and SI are performing endoscopy. The site does not\nhave adolescent patients for ulcerative colitis study; the site addresses only for adult patients with\ngastrointestinal diseases.\nThe site prefers patient travel reimbursement via direct payment on bank account.\nPI has not CV on EUCTR template.\nSC was informed that all validation/calibration certificates for study equipment needs to be available before SIV.\nrequirements.\nThe following items for consideration detected:\n • Only one pharmacist -Dr. Mariana Fary is present in pharmacy-so there no back pharmacist.\n • Only one SC -Milan Hanuska is present at the site and also only in pharmacist-so there no back for SC and\npharmacist.\n • Missing calibration validation certificates related to thermometer for fridge, freezer and for min/max\nthermometer for IP temperature monitoring, for body thermometer, scale, for Sphygmamometer for measuring\nBP, centrifuge etc.\n • Site has not Stadiometer for measuring height, Incubator for -TB test\n • Patient population limited to patients with intolerance or inadequate response to ADT-naive only\n • The other point of view for consideration is licensure: SI Dr. Jungwirt is qualified by education and have 4\nyears experience with surgery certification and endoscopy specialization.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o oboje ale není biol centrum, jen 5 CD ročně a 20 UC rocně. jen naivni pacienti takye nic",
|
||
"FINAL DECISION PRO ICONIC IBD": "Spise Ne - kvuli omezenym zkusenostem se studiemi i SI, ktery by fakticky provadel",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "22APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "22APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 připomínka, aby vyplnila SIPIQ\n01APR2025 email jestli zájem 9APR2025 Svetlana se zepta 10APR má zájem, volat na 603 195 640",
|
||
"Společnost na CDA": "EGK s.r.o. - Sanatorium sv. Anny",
|
||
"PI Last Name": "Jungwirthova",
|
||
"PI First Name": "Anna",
|
||
"PI Email Address": "a.jungwirthova@egk.cz",
|
||
"PI Phone Number": "+42 060 319 5640",
|
||
"PI Full Address": "Lucni 7a,,,Prague,",
|
||
"Primary Institution Name": "EGK s.r.o. - Sanatorium sv. Anny",
|
||
"Site Address": "Lucni 7a",
|
||
"Site City": "Prague",
|
||
"Site Zip/Postal Code": "13000",
|
||
"St # required subj": "3",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2018-11-30 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Stehlik"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "64304500CRD2001",
|
||
"Strategic Priority": "2 - Core",
|
||
"Pr Status CTMS": "Completed",
|
||
"Pr-Cn Status": "Not Selected",
|
||
"Cn # sites": "0",
|
||
"Pr-Cn # Sites Open": "0",
|
||
"Cn # screened": "0",
|
||
"Cn # enrolled": "0",
|
||
"Cn # completed": "0",
|
||
"Cn # screen fail": "0",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Panorama CD, Zuzka high performance 1x and low performance 1x",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano - máme dr Tichého",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Stehlik",
|
||
"PI First Name": "Jiri",
|
||
"PI Email Address": "stehlikJ@mnul.cz - nefunguje; jiri.stehlik@kzcr.eu",
|
||
"PI Phone Number": "+42 47 711 2430",
|
||
"PI Full Address": "Socialni pece 3316/12A,,,Usti nad Labem,Usti nad Labem",
|
||
"Primary Institution Name": "Masarykova nemocnice v Usti nad Labem",
|
||
"Primary Institution Phone Number": "+00420477111111000 000 000 000 000",
|
||
"Site Address": "Socialni pece 3316/12A",
|
||
"Site City": "Usti nad Labem",
|
||
"Site Zip/Postal Code": "401 13",
|
||
"St # required subj": "0",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Papik"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3001",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-09-25 00:00:00",
|
||
"HA Init Appr Act": "2018-06-20 00:00:00",
|
||
"Cn # expected subj": "13",
|
||
"Cn # screened": "24",
|
||
"Cn # enrolled": "16",
|
||
"Cn # completed": "10",
|
||
"Cn # screen fail": "8",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "8",
|
||
"Pr-St Status": "Not Selected",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama CD",
|
||
"EMA": "CD 1x po náboru ale v Nachodě",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "09MAY2025 nastaveno nemá zájem",
|
||
"Illumninator status UC": "09MAY2025 nastaveno nemá zájem",
|
||
"PI Last Name": "Papik",
|
||
"PI First Name": "Zdenek",
|
||
"PI Email Address": "papik.zdenek@nemocnicenachod.cz",
|
||
"PI Phone Number": "+420 491 601 577",
|
||
"PI Full Address": "Na Obinách 1809,,Gastroenterology and Hepatology,Hradec Králové,",
|
||
"Primary Institution Name": "Zdenk Papik",
|
||
"Site Address": "Na Obinách 1809 Gastroenterology and Hepatology",
|
||
"Site Address Line 3": "Gastroenterology and Hepatology",
|
||
"Site City": "Hradec Králové",
|
||
"Site Zip/Postal Code": "547 01",
|
||
"St # required subj": "5",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Voska"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3001",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-09-25 00:00:00",
|
||
"HA Init Appr Act": "2018-06-20 00:00:00",
|
||
"Cn # expected subj": "13",
|
||
"Cn # screened": "24",
|
||
"Cn # enrolled": "16",
|
||
"Cn # completed": "10",
|
||
"Cn # screen fail": "8",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "8",
|
||
"Pr-St Status": "Execution",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama CD - good performance 1x, Panorama UC pod Serclovou v Budinova 2 ktera asi odesla",
|
||
"EMA": "CD 1 po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Voska",
|
||
"PI First Name": "Michal",
|
||
"PI Email Address": "voska@nemocnice-horovice.cz; michal.voska@uvn.cz; michal.voska@gmail.com",
|
||
"PI Phone Number": "+420 77 320 0360",
|
||
"PI Full Address": "K Nemocnici 1106,Chirurgicke oddeleni,,Horovice,",
|
||
"Primary Institution Name": "NH Hospital, a.s.",
|
||
"Site Address": "K Nemocnici 1106 Chirurgicke oddeleni",
|
||
"Site Address Line 2": "Chirurgicke oddeleni",
|
||
"Site City": "Horovice",
|
||
"Site Zip/Postal Code": "268 31",
|
||
"St # required subj": "3",
|
||
"St # screened": "6",
|
||
"St # enrolled": "3",
|
||
"St # completed": "2",
|
||
"St # screen fail": "3",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "1",
|
||
"St Qualified Act": "2017-12-29 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Drastich"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3001",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-09-25 00:00:00",
|
||
"HA Init Appr Act": "2018-06-20 00:00:00",
|
||
"Cn # expected subj": "13",
|
||
"Cn # screened": "24",
|
||
"Cn # enrolled": "16",
|
||
"Cn # completed": "10",
|
||
"Cn # screen fail": "8",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "8",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama CD - low performance 1x, Panorama UC s Benesem 0 z 15",
|
||
"EMA": "UC 3x nábor, CD 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano s prof. Huclem",
|
||
"LTM": "Helena - namisto Drasticha prof. Hucl",
|
||
"Comment": "Preposlal na Dr. Drasticha",
|
||
"PI Last Name": "Drastich",
|
||
"PI First Name": "Pavel",
|
||
"PI Email Address": "drastich@hotmail.com",
|
||
"PI Phone Number": "+420 26 136 2696",
|
||
"PI Full Address": "Videnska 1958/9,,Klinika hepatogastrologie,Praha,",
|
||
"Primary Institution Name": "IKEM",
|
||
"Site Address": "Videnska 1958/9 Klinika hepatogastrologie",
|
||
"Site Address Line 3": "Klinika hepatogastrologie",
|
||
"Site City": "Praha",
|
||
"Site Zip/Postal Code": "140 21",
|
||
"St # required subj": "3",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2022-03-15 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Zadorova"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3001",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-09-25 00:00:00",
|
||
"HA Init Appr Act": "2018-06-20 00:00:00",
|
||
"Cn # expected subj": "13",
|
||
"Cn # screened": "24",
|
||
"Cn # enrolled": "16",
|
||
"Cn # completed": "10",
|
||
"Cn # screen fail": "8",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "8",
|
||
"Pr-St Status": "Closed",
|
||
"Repeat PI": "Yes",
|
||
"Světlana, Zuzka, Panorama": "Panorama - good performance 1x, low performance1x",
|
||
"EMA": "UC 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s dr Matoušem - máme dr Šerclovou",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Zadorova",
|
||
"PI First Name": "Zdena",
|
||
"PI Email Address": "zadorova@fnkv.cz; zadorova@endogastro.cz",
|
||
"PI Phone Number": "+42 026 716 2719",
|
||
"PI Full Address": "Srobarova 50,II. Interni klinika,,Praha 10,",
|
||
"Primary Institution Name": "Fakultni nemocnice Kralovske Vinohrady",
|
||
"Primary Institution Phone Number": "+420267163531",
|
||
"Site Address": "Srobarova 50 II. Interni klinika",
|
||
"Site Address Line 2": "II. Interni klinika",
|
||
"Site City": "Praha 10",
|
||
"Site Zip/Postal Code": "100 34",
|
||
"St # required subj": "1",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2017-12-22 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Svoboda"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959CRD3001",
|
||
"Strategic Priority": "5 - Priority File",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Execution",
|
||
"Cn # Sites Exp": "6",
|
||
"Cn # sites": "6",
|
||
"Pr-Cn # Sites Open": "6",
|
||
"Cn F Site Open Exp": "2018-09-25 00:00:00",
|
||
"HA Init Appr Act": "2018-06-20 00:00:00",
|
||
"Cn # expected subj": "13",
|
||
"Cn # screened": "24",
|
||
"Cn # enrolled": "16",
|
||
"Cn # completed": "10",
|
||
"Cn # screen fail": "8",
|
||
"Cn # early term": "1",
|
||
"Cn # disc treatm": "8",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama - low performancec 1x",
|
||
"EMA": "UC 3x nábor a 2x po náboru, CD 1x v náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_BvQDtsmZY7NyQei_b11cOvqU1TI0p3U_CGC_t1XM5HEI4J6HpEz&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Dan",
|
||
"SM poznámky": "5.5. kontaktovano centrum, \nPI na dovolene do konce tydne, zavolat v Po 12.5. okolo 7:30, 12.5.7:30 centrum kontaktovano, PI opakovaně nezveda v prubehu dne, volat na cislo s poslednimi 4cislim 4061, 13.5 neni pritomen, volat 14.5 od 7:00 dal",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "Remote 23.5 v 12:00",
|
||
"SIPIQ zajímavosti": "nemá zkušenost s c-ssrs",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. 3 (1:2) / 3 (1:2)",
|
||
"Počet pacientů SQV": "2 rand. UC a 2-3 rand. CD",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "3 studie běžící, smlouva až půl roku (ale v AML nejrychlejsi mezi fakultkama), vedeli, znali, nabirali by tezsi pacienty, co selhali na biol lecbe, nechteji podstudii.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o oboje 50:130 CD a 40:110 UC.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO 9/10 ale fakultka, tezsi pacienti",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "17APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "17APR2025 SIPIQ odeslán",
|
||
"Comment": "01APR2025 má zájem, poslat SIPIQ\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Fakultní nemocnice Ostrava",
|
||
"PI Last Name": "Svoboda",
|
||
"PI First Name": "Pavel",
|
||
"PI Email Address": "pavel.svoboda@fno.cz",
|
||
"PI Phone Number": "+420 59 737 4191",
|
||
"PI Full Address": "17. listopadu 1790,Interni klinika,,Ostrava - Poruba,město",
|
||
"Primary Institution Name": "Fakultni Nemocnice Ostrava",
|
||
"Primary Institution Phone Number": "420597372240",
|
||
"Site Address": "17. listopadu 1790 Interni klinika",
|
||
"Site Address Line 2": "Interni klinika",
|
||
"Site City": "Ostrava - Poruba",
|
||
"Site Zip/Postal Code": "70852",
|
||
"St # required subj": "8",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0",
|
||
"St Qualified Act": "2017-12-29 00:00:00"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Bronsky"
|
||
},
|
||
"excel": {
|
||
"Protocol ID": "CNTO1959PBCRD3007",
|
||
"Strategic Priority": "2 - Core",
|
||
"Pr Status CTMS": "Execution",
|
||
"Pr-Cn Status": "Cancelled",
|
||
"Cn # Sites Exp": "1",
|
||
"Cn # sites": "0",
|
||
"Pr-Cn # Sites Open": "0",
|
||
"Cn # expected subj": "4",
|
||
"Cn # screened": "0",
|
||
"Cn # enrolled": "0",
|
||
"Cn # completed": "0",
|
||
"Cn # screen fail": "0",
|
||
"Cn # early term": "0",
|
||
"Cn # disc treatm": "0",
|
||
"Pr-St Status": "Cancelled",
|
||
"Repeat PI": "No",
|
||
"Světlana, Zuzka, Panorama": "Panorama uC a CD zrušeny. Druhý lékař Keil a Hradsky.",
|
||
"EMA": "CD 1x v naboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano s doc Hradským",
|
||
"Adolescenti": "Ano",
|
||
"LTM": "Vlado",
|
||
"Comment": "04APR2025 nemá zájem\n01APR2025 email jestli zájem 9APR2025 má zájem o inhibitor IL-23. Znovu oslovit!!!!",
|
||
"PI Last Name": "Bronsky",
|
||
"PI First Name": "Jiri",
|
||
"PI Email Address": "jiri.bronsky@gmail.com",
|
||
"PI Phone Number": "+420 22 443 1111",
|
||
"PI Full Address": "Interni klinika V Uvalu 84,,Dept of Kardiologicka klinika 2.LF UK a FN Motol,Praha 5,",
|
||
"Primary Institution Name": "Fakultni nemocnice v Motole",
|
||
"Primary Institution Phone Number": "+4202244340010000 000 000 000",
|
||
"Site Address": "Interni klinika V Uvalu 84 Dept of Kardiologicka klinika 2.LF UK a FN Motol",
|
||
"Site Address Line 3": "Dept of Kardiologicka klinika 2.LF UK a FN Motol",
|
||
"Site City": "Praha 5",
|
||
"Site Zip/Postal Code": "150 06",
|
||
"St # screened": "0",
|
||
"St # enrolled": "0",
|
||
"St # completed": "0",
|
||
"St # screen fail": "0",
|
||
"St # early term": "0",
|
||
"St # disc treatm": "0"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Horny"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Zuzka - no new studies, performance, Panorama UC dobrý nábor 2 ze 2",
|
||
"EMA": "UC 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "09MAY2025 nastaveno nemá zájem",
|
||
"Illumninator status UC": "NA",
|
||
"Comment": "VB: oslovilas ho Helčo? Ano opakovane emailem, na obe adresy, 18.4. - zatim bez odpovedi",
|
||
"PI Last Name": "Horny",
|
||
"PI First Name": "Ivo",
|
||
"PI Email Address": "interna@nemst.cz; ivo.horny@post.cz",
|
||
"PI Phone Number": "420 383 314 240",
|
||
"Primary Institution Name": "Hospital Strakonice",
|
||
"Site Address": "Radomyslska 336, Strakonice I,"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hrdlicka"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Zuzka - drop - currently site not interested in the studies, focused on commercial treatment, development, Panorama UC ok nábor 1 ye 2 pacientu, doporuceni vladky",
|
||
"EMA": "CD 1 po naboru u dr Stovicka jan.stovicek@restrial.com a +420730893972",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano dr Hrdlička",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "není ani v Iluminatoru, žádná akce tam",
|
||
"Illumninator status UC": "není ani v Iluminatoru, žádná akce tam",
|
||
"Comment": "01APR2025 Restrial je saturovaný nemají zájem\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Hrdlicka",
|
||
"PI First Name": "Ludek",
|
||
"PI Email Address": "gastroendoP8@restrial.com",
|
||
"Primary Institution Name": "ResTrial GastroEndo, s.r.o., Praha"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Machytka"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Zuzka - development, Panorama UC a splněno",
|
||
"J&J studie": "Quasar",
|
||
"EMA": "UC 1x nábor pending a 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "09MAY2025 nastaveno nemá zájem",
|
||
"Illumninator status UC": "NA",
|
||
"Comment": "VB: oslovilas ho Helčo? Ano opakovane emailem, na obe adresy, 18.4. - zatim bez odpovedi",
|
||
"PI Last Name": "Machytka",
|
||
"PI First Name": "Tomas",
|
||
"PI Email Address": "machytka@endohope.cz",
|
||
"PI Phone Number": "420 620 603 388",
|
||
"Primary Institution Name": "Asclepiades, Havirov"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Siroky"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Zuzka - good performance, Panorama UC high performance",
|
||
"J&J studie": "Astro (7), Anthem, Quasar",
|
||
"EMA": "UC1x nábor a 3x po náboru, CD1x ukončen",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale dr Široký Pardubice!!!",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"Comment": "01APR2025 bohužel nemá zájem, má nasmlouvané další studie a nemá prostor pro další\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Siroky",
|
||
"PI First Name": "Milan",
|
||
"PI Email Address": "m.sirokydr@gmail.com",
|
||
"Primary Institution Name": "Gastroenterologie, s.r.o., HK"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Smajstrla"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Zuzka - development, Panorama UC 0 ze 2 pacientu 2x",
|
||
"J&J studie": "Astro (0), Quasar",
|
||
"EMA": "UC 2x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"Comment": "01APR2025 nemájí dost pacientů, referalové neposílají, nechce, podobně jako Anthem\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Smajstrla",
|
||
"PI First Name": "Vit",
|
||
"PI Email Address": "bormed1@volny.cz, vit.smajstrla@bormed.cz",
|
||
"PI Phone Number": "420 733 374 388",
|
||
"Primary Institution Name": "ATROSCAN, Ostrava"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Komarek"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Panorama UC 2 z 5",
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano přes Restrial s dr Hrdličkou",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "01APR2025 email jestli zájem 9APR2025 odmítnutí přes Restrial dr Hrdličku, nemají kapacitu na další studie",
|
||
"PI Last Name": "Komarek",
|
||
"PI First Name": "Viktor",
|
||
"PI Email Address": "viktor.komarek@volny.cz",
|
||
"Primary Institution Name": "Medicon Praha"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Janu"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"EMA": "UC 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "N/A",
|
||
"LTM": "Vlado",
|
||
"Comment": "Janů je a vždy byl psychiatr :-)",
|
||
"PI Last Name": "Janu",
|
||
"PI First Name": "Lubos",
|
||
"PI Email Address": "lubos.janu@seznam.cz",
|
||
"PI Phone Number": "00420 777 242 101",
|
||
"Primary Institution Name": "nebo dr Kozeluhová ve FN Plzen (Panorama UC) a Hejda ve FN Plzen, kter7 v Panorama UC 0 ze 34 pacientu",
|
||
"Site City": "Plzen"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Koželuhová"
|
||
},
|
||
"excel": {
|
||
"HA Init Appr Act": "fa",
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"LTM": "Vlado",
|
||
"Comment": "01APR2025 nemají personál, nemohou\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Koželuhová",
|
||
"PI First Name": "Jana",
|
||
"PI Email Address": "kozeluhova@fnplzen.cz",
|
||
"Site City": "Znojmo"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hejda"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale Bouchner pokud Edvarda beneše, Plzen (Kozehulová alej Svobody)",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_Yug1jK54C2nI4dh_b11cOvqU1TI0p3U_CGC_XsqnmDJIYEecVNZ&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "5.5.- 377 403 322 (spojovatelka) , Dr.Hejda (Lochotín) 377103322 - obsazeno (nebo 3234)\n6.5.- dopoledne opakovaně voláno na linka 3322, buď nebere nebo je obsazeno",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "25APR2025 SIPIQ odeslán",
|
||
"Illumninator status UC": "25APR2025 SIPIQ odeslán",
|
||
"Comment": "29APR2025 připomínka, ať vyplní feasibility dotazník\n25APR2025 má zájem o feasibilitu\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Fakultní nemocnice Plzeň",
|
||
"PI Last Name": "Hejda",
|
||
"PI First Name": "Václav",
|
||
"PI Email Address": "hejdav@fnplzen.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vitek"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "ano ale s dr Pospíšilovou",
|
||
"Adolescenti": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "04APR2025 nemá zájem\n01APR2025 email jestli zájem",
|
||
"PI Last Name": "Vitek",
|
||
"PI First Name": "Petr",
|
||
"PI Email Address": "vitekp@nemfm.cz",
|
||
"Site City": "Frydek Mistek"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Krížová"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "ano ale dr Mareš",
|
||
"LTM": "Vlado",
|
||
"Comment": "25APR2025 opakování emailu\n22APR2025 opakování emailu\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Homolka",
|
||
"PI Last Name": "Krížová",
|
||
"PI First Name": "Viera",
|
||
"PI Email Address": "viera.krizova@homolka.cz",
|
||
"Site City": "Homolka"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Tomsová"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "25APR2025 opakování emailu\n22APR2025 opakování emailu\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Nemocnice Bladá Boleslav",
|
||
"PI Last Name": "Tomsová",
|
||
"PI First Name": "Eva",
|
||
"PI Email Address": "eva.tomsova@onmb.cz",
|
||
"Site City": "Mlada Boleslav"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Nedbalová"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "NA",
|
||
"LTM": "Vlado",
|
||
"Illuminator status CD": "není ani v Iluminatoru, žádná akce tam",
|
||
"Illumninator status UC": "není ani v Iluminatoru, žádná akce tam",
|
||
"Comment": "09APR2025 nemá zájem (odpověděla)\n01APR2025 email jestli zájem 9APR2025 Svetlana se zepta 2MAy, je dulezita pro JnJ",
|
||
"Společnost na CDA": "Nemocnice LIberec",
|
||
"PI Last Name": "Nedbalová",
|
||
"PI First Name": "Lenka",
|
||
"PI Email Address": "lenka.nedbalova@nemlib.cz",
|
||
"Site City": "Liberec"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Matuska"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "Matuška je a vždy byl angiolog",
|
||
"PI Last Name": "Matuska",
|
||
"PI First Name": "Jiri",
|
||
"Site City": "Hodnonín"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hadraba"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne Teplice s Hadrabou, Ano Ústí se Stehlíkem",
|
||
"LTM": "Vlado",
|
||
"Comment": "25APR2025 oslovil jsem MUDr. Michal Tichý, který měl zájem, tedy toto centrum dávám červeně\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "Nemocnice Ústí nad Labem",
|
||
"PI Last Name": "Hadraba",
|
||
"PI First Name": "Ladislav",
|
||
"PI Email Address": "ladislav.hadraba@kzcr.eu",
|
||
"Site City": "Teplice"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Gabalec"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL UC",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Vlado",
|
||
"Comment": "25APR2025 nemá zájem, nemá kapacitu\n01APR2025 email jestli zájem",
|
||
"Společnost na CDA": "internista - gastroenterolog",
|
||
"PI Last Name": "Gabalec",
|
||
"PI First Name": "Libor",
|
||
"PI Email Address": "libor.gabalec@seznam.cz",
|
||
"Site City": "Ústí nad Orlicí"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Machkova"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL CD",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Je diabetolog",
|
||
"PI Last Name": "Machkova",
|
||
"PI First Name": "Martina",
|
||
"Site City": "Praha"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hala"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL CD",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Uz nepracuje v CCBR Padubice",
|
||
"PI Last Name": "Hala",
|
||
"PI First Name": "Tomas",
|
||
"Primary Institution Name": "CCR",
|
||
"Site City": "Pardubice"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Gregar"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Panorama UC a nenabral",
|
||
"Illuminator when no site in the city or interesting": "ILL CD",
|
||
"EMA": "UC 1x po náboru, CD 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_2ak5fxi84tGaQgP_b11cOvqU1TI0p3U_CGC_iXWGhg4Mn5YDBCv&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "5.5. 12:45- nikdo nezvedá\n13:0- Dr.Gregar má dnes dovolenou, bude k dispozici zítra 6.5. cca 11-12h (ráno má kolonoskopii a ambulance)- linka 588 445 3026.5.- ve FNO je dr.Gregar slíbil, že se koukne a budu mu volat zítra 7.5. na 583 211 542- soukromá ordinace Gregar s.r.o. (https://www.mudr-gregar.cz/), adresa Čajkovského 14, 779 00 Olomouc 9- PI je tam st, čt, pá\n7.5. zanechán vzkaz, neozval se zpět\n9.5. nikdo nezvedá ne recepci",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "20.4. vyžádáno Zuzka , 2.5 zaslána upomínka s návodem, aby CDA podepsal",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "VB: odsouhlasil mi to včera po telefonu (08APR2025)",
|
||
"Společnost na CDA": "někde kolem Olomouce",
|
||
"PI Last Name": "Gregar",
|
||
"PI First Name": "Jan",
|
||
"PI Email Address": "jan.gregar@fnol.cz; info@mudr-gregar.cz",
|
||
"PI Phone Number": "585 428 910, 588445302",
|
||
"PI Full Address": "adresa Čajkovského 14, 779 00 Olomouc 9",
|
||
"Primary Institution Name": "MUDr. GREGAR s.r.o.",
|
||
"Site Address": "Cajkovskeho 67/14, Nova Ulice, Czechia",
|
||
"Site City": "Olomouc"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Woznica"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL CD",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_hIH02NdzdfgQlK7_b11cOvqU1TI0p3U_CGC_6iI0r72PUfNrhii&_g_=g",
|
||
"SM": "Ivetka",
|
||
"SM poznámky": "Dr. Woznica kontaktován telefonicky 6.5. vyplnit SIPIQ",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "Nemá zájem dle SIPIQ",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "CDA fully signed - PI varianta",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "Ano chteji se na studii podivat, ale obavaji se slozitosti studie. Pokud bude hodne pristupu do systemu, hodne koloskopii do studie nechteji.",
|
||
"Společnost na CDA": "Most",
|
||
"PI Last Name": "Woznica",
|
||
"PI First Name": "Vlastimil",
|
||
"PI Email Address": "gastroambulanceVW@seznam.cz",
|
||
"PI Phone Number": "42041763324",
|
||
"Primary Institution Name": "Vítěslava Nezvala 2678/37, 43401 Most 1",
|
||
"Site City": "Most"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Závada"
|
||
},
|
||
"excel": {
|
||
"Illuminator when no site in the city or interesting": "ILL CD",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "09MAY2025 nastaveno nemá zájem",
|
||
"Illumninator status UC": "09MAY2025 nastaveno nemá zájem",
|
||
"PI Last Name": "Závada",
|
||
"PI First Name": "Filip",
|
||
"PI Email Address": "filip.zavada@onp.cz",
|
||
"Site City": "Příbram"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Schwarz"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ano",
|
||
"LTM": "Helena",
|
||
"Comment": "Nemá aktuálně zájem",
|
||
"PI Last Name": "Schwarz",
|
||
"PI First Name": "Jan",
|
||
"PI Email Address": "schwarzj@fnplzen.cz",
|
||
"PI Phone Number": "420 377 104 679"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Študent"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Študent",
|
||
"PI First Name": "Vladimír",
|
||
"PI Email Address": "studentnempt@seznam.cz",
|
||
"PI Phone Number": "420 775 063 924",
|
||
"Primary Institution Name": "Nemocnice Prachatice a.s.",
|
||
"Site Address": "Nebahovska 1015, Prachatice, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vyhnálek"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x po náboru, CD 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Už je viz výše řádek 15, Ano s dr Leksou",
|
||
"LTM": "Helena",
|
||
"Comment": "Pardubice takže jako Kubát. Vyhnálek na starosti biologika.",
|
||
"PI Last Name": "Vyhnálek",
|
||
"PI First Name": "Petr",
|
||
"PI Email Address": "petr.vyhnalek@nempk.cz",
|
||
"PI Phone Number": "+420 466 014 201",
|
||
"Primary Institution Name": "Nemocnice Pardubickeho kraje a.s.",
|
||
"Site Address": "Kyjevska 44 Pardubicky, Pardubice, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Pumprla"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_RDG7qO4m0cuSyBo_b11cOvqU1TI0p3U_CGC_OK2auPx5ULHTDRY&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Vlaďka",
|
||
"SM poznámky": "14.05. jsem volala, mel SIV. Zkusim znovu zitra",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "21.5. v 14:00 on-site",
|
||
"SIPIQ zajímavosti": "Nemá chest radiograph",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 5 (5:0) / 4 (4:0)",
|
||
"Počet pacientů SQV": "UC (5 screen / 4 random)\nCD (4 screen / 3 random)",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "PI is interested in both ICONIC-IBD studies (UC and CD) and confirms that the site has sufficient time to conduct the study. The study team has experience with clinical trials, the site has sufficient equipment and space for conducting the study. PI is experienced in clinical trials, has conducted around 37 studies. All other team members are also qualified by experience and appropriate certifications. Collaboration with several SIs in the area facilitates a large database of prospective study participants. Additional comment: The site is not interested in participating in the IUS sub-study, since intestinal ultrasounds are not regularly\nperformed at the site. \nThe site does not have an adolescent patient population to include in the UC study.\nThe site prefers cash payments for patient reimbursement, invoices will be generated after the payment. Zkusene centrum, PI vse zna, 8 SC na centrum, ve studii 3 SC, PI gastroenterolog není ale SI jsou a jezdí na kolonoskopie k 5 jiným SI (az do ZLina) - oni doporucuji pacienty, vse u Pumrply na centru, ale kolonoskopie jinde a SC jezdí s laptopem. vse maji, rtg na poliklinice, lekarna je u nej.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o oboje 10:90 UC a 5:35 CD ročně (ale ty hlavne nerefuje). Spise naivni pacienti, tkaze otazka, jak u dalsich studiich.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO (8 z 10)",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "CDA fully signed - Instution PREVENTAMED",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "Ano, chtějí do feasky a podívat se na design",
|
||
"Společnost na CDA": "PreventaMed s.r.o. (Olomouc)",
|
||
"PI Last Name": "Pumprla",
|
||
"PI First Name": "Jiří",
|
||
"PI Email Address": "research@vilazdravi.cz",
|
||
"PI Phone Number": "+420 602 708 148",
|
||
"Primary Institution Name": "Privatni gastroenterologicka ambulance s.r.o., MUDr. Zdenek Vlk",
|
||
"Site Address": "Winklerova 23, Prostejov, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Matejovska Kubesova"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ozval se Jan Hudec z Efertus - doporucil oslovit 2 pracoviste Nemocnice Břeclav, prim. MUDr. Ryšavý vladan.rysavy@gmail.com - ten nema kapacitu a Vsetín, MUDr. Vaculín - endovsetin@seznam.cz a Mudr. Matej Falc https://www.gastrohepacentrum.cz/",
|
||
"PI Last Name": "Matejovska Kubesova",
|
||
"PI First Name": "Hana prof",
|
||
"PI Email Address": "hana.matejovska@efertusclinical.com",
|
||
"PI Phone Number": "420 606 417 244",
|
||
"Primary Institution Name": "EFERTUS clinical s.r.o.",
|
||
"Site Address": "Smetanova 902, Vsetin, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Brtníkova"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 3x v náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne, mají konkurenční studie",
|
||
"PI Last Name": "Brtníkova",
|
||
"PI First Name": "Sylva",
|
||
"PI Email Address": "sylva.brtnikova@ccrostrava.com",
|
||
"PI Phone Number": "420 734 522 986",
|
||
"Primary Institution Name": "CCR Ostrava"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Košková"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Panorama UC Not selected",
|
||
"EMA": "UC 1x nábor, CD 1x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Košková",
|
||
"PI First Name": "Radka",
|
||
"PI Email Address": "mudr.koskova@seznam.cz",
|
||
"PI Phone Number": "420 602 110 107",
|
||
"Primary Institution Name": "EndoArt s.r.o.",
|
||
"Site Address": "Hladnovska 1255/23, Slezska Ostrava, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Maceček"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne, nema zajem. Maji 3 konkurencni studie",
|
||
"PI Last Name": "Maceček",
|
||
"PI First Name": "Jaroslav",
|
||
"PI Email Address": "jaroslav.macecek@smn.agel.cz",
|
||
"PI Phone Number": "420 724 924 653",
|
||
"Primary Institution Name": "AGE Centrum s.r.o.",
|
||
"Site Address": "Na Sibeniku 914/1 Nova Ulice, Olomouc, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Martínek"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC1x po nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano ale s prof Kianičkou",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne, v jednání s jinými zadavateli, stejná cílová skupina - ještě potvrdí barbora.kudrnovska@fnusa.cz - potvrdila, ze zajem nemaji",
|
||
"PI Last Name": "Martínek",
|
||
"PI First Name": "Jan prof",
|
||
"PI Email Address": "jan.martinek@fnusa.cz",
|
||
"PI Phone Number": "+420 543 182 253",
|
||
"Primary Institution Name": "FNUSA Taky 1x po náboru u dr Kláry Slapalové UC a CD 3 ukonceny"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Čechová"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 5x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_AwAvCXtrVvzP7Dj_b11cOvqU1TI0p3U_CGC_fAosimA1L3PjsLo&_g_=g",
|
||
"SM": "???",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "3.5. vyžádáno Zuzka",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "MOžná ano, potřebují vědět o co přesně jde",
|
||
"Společnost na CDA": "Urazova nem. Brno",
|
||
"PI Last Name": "Čechová",
|
||
"PI First Name": "Ivana",
|
||
"PI Email Address": "ivanacechova@ccrbrno.cz; i.cechova@unbr.cz",
|
||
"PI Phone Number": "+420 734 574 598",
|
||
"Primary Institution Name": "Urazova nemocnice Brno"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hradský"
|
||
},
|
||
"excel": {
|
||
"Světlana, Zuzka, Panorama": "Panorama UC Keil 0 ze 34 a Bronsky kde zruseno",
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ano",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne, nemají kapacitu na další studii",
|
||
"PI Last Name": "Hradský",
|
||
"PI First Name": "Ondřej",
|
||
"PI Email Address": "ondrej.hradsky@lfmotol.cuni.cz",
|
||
"PI Phone Number": "420 224 432 098",
|
||
"Primary Institution Name": "Fakultni Nemocnice V Motole",
|
||
"Site Address": "V Uvalu 84/1, Prague, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Psottová"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC1x nábor a 2x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ozval se Jan Hudec z Efertus - doporucil oslovit 2 pracoviste Nemocnice Břeclav, prim. MUDr. Ryšavý vladan.rysavy@gmail.com - ten nema kapacitu a Vsetín, MUDr. Vaculín - endovsetin@seznam.cz a Mudr. Matej Falc https://www.gastrohepacentrum.cz/",
|
||
"PI Last Name": "Psottová",
|
||
"PI First Name": "Jana",
|
||
"PI Email Address": "jana.psottova@gmail.com",
|
||
"PI Phone Number": "420 274 771 534",
|
||
"Primary Institution Name": "EFERTUS clinical s.r.o.",
|
||
"Site Address": "Stroupeznickeho 529/6, Prague, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Mudr"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nabor pending",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_VgT6PLnFqrDvz2g_b11cOvqU1TI0p3U_CGC_VtwMtuf67lrXila&_g_=g",
|
||
"SM": "Lenka",
|
||
"SM poznámky": "5.5.- Dr. Mudr -linka 397, 257 197 306 Dr. Pěkný- studijní koordinátor, temín selekce domluvit s ním- zatím nedostupný. Dnes má ambulanci do 16h - ozve se sám dnes a nebo zítra, úterky má volnější. Dr.Pekny volala. Slíbil, že PI vyplní feasibilitu a domluvili jsme osoobní termín selekce",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "13.5. v 12:00 on-site",
|
||
"SIPIQ zajímavosti": "Nemá mrazák -70, jinak nic co by vybocovalo",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "7 (3:4) / 7 (3:4)",
|
||
"Počet pacientů SQV": "potvrdil data ze SipIQ cca 4-5 randomizovaných pacientů CD i UC",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "SM recommends the site.\nThe SM recommends the site for participation based on potential subject population, correct staffing, space for\nconducting the study, qualification and previous experience in clinical trials (including UC a CD) and interest in\nthe proposed trial. Additional comments:SI/SC will clarify whether the site will participate in the IUS sub-study - check with the radiologist for availability.\nSI/SC confirmed that most patients will be able to use BYOD. He would like to receive a few handhelds on the\nsite, for those who don't have suitable phones. Centrum zkušené, PI vytížený, ale komunikuje Potřebují inkubátor.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o oboje. v UC i CD udává 500 ale pak v obojím 200:150. 500 pacientu ma. Neberou studií více, ale další studie se muze zeptat.",
|
||
"FINAL DECISION PRO ICONIC IBD": "ANO",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "18.4. vyžádáno Zuzka , 2.5. upomínka podepsat CDA zasláno PI",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "Ano, mají zájem o feasku",
|
||
"Společnost na CDA": "Boromejky, Praha",
|
||
"PI Last Name": "Mudr",
|
||
"PI First Name": "Robert",
|
||
"PI Email Address": "robert.mudr@nmskb.cz, kontaktovat tez SI petr.pekny@nmskb.cz",
|
||
"PI Phone Number": "257 197 305; Dr.Pěkný Petr (SI/SC) 603 399 032",
|
||
"Primary Institution Name": "Nemocnice Milosrdnych Sester Sv. Karla Boromejskeho V Praze",
|
||
"Site Address": "Vlasska 336/36, Prague, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Král"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x nábor",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_Url91ryMx67ipE5_b11cOvqU1TI0p3U_CGC_WN42Op2yK6RQk0C&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Iveta",
|
||
"SM poznámky": "2.5 a 5.5. jsem několikrát zkoušela na mobil bez odezvy- napsán e-mail stran stanovení termínu selekční návštěvy/PI-je v Sam Diegu/zavolat 12.5.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "19:5. v 11:30 zájem o lék má, ale avizoval, zda je možné eventuelně zrušit participaci v případě výběru centra během srpna? Což je trochu nestandartní",
|
||
"SIPIQ zajímavosti": "Potřeboval by pomoct s SC? Ale staff má. Nemá zkušenost s UC ediaries Mayo?, dotazníky, C-SSRS, nemá inkubátor, IGRA,",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol?? 3 (1:2) / NA",
|
||
"Počet pacientů SQV": "3 pacienti UC",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Ma zkusenosti 6-12 studiemii. 3-4 pacienti UC. Selhane na biol lecbe z Motola. Nema dostatek personalu. Bude to vedet az v srpnu jestli personalne zvaldne. Hlavne nadseny, ze je PO. All team members are qualified by certificates and experience for this study.\nThe SM recommends the site for participation based on potential subject population, and equipment, previous\nexperience in clinical trials and interest in the proposed trial but only with the condition of enough staff for\nconducting of study which will be known in Aug25 as was confirmed by PI during SQV.\nThe other point of view for consideration is licencure: SI Dr. Svet and SI Dr. Turcanova are qualified by education\nand have 5 years experience without any certification. Additonal comments: The site is not interested in performing IUS sub-study; both PI and SI are performing endoscopy.\n The site does not have adolescent patients for ulcerative colitis study; the site addresses only for adult patients\nwith gastrointestinal diseases.\nThe adolescents (patients under 18 years old) are presenting to the pediatrician for this type of diseases.\nThe site prefers patient travel reimbursement via direct payment on bank account.\nPI has not CV on EUCTR template.\nPI was informed that all validation/calibration certificates for study equipment needs to be\navailable before SIV",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Má zájem jen o UC. udává jen 5 pacientu rocně. Navíc nebiol centrum?? selhane pacienty si referuje z Motola",
|
||
"FINAL DECISION PRO ICONIC IBD": "Spise Ne - jelikoz nevi jak to bude mit personalne.",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "13MAY25 VB vyžádal zaslání CDA pro nového PI MUDr. Petr Hrabák\nCDA fully signed - institution varianta(Macásek)",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "approved for feasibility",
|
||
"Illumninator status UC": "approved for feasibility",
|
||
"Comment": "Spíš ne, ale feasku mame poslat - chce znát inclusion/exclusion",
|
||
"Společnost na CDA": "MUDr. Jan Král",
|
||
"PI Last Name": "Král",
|
||
"PI First Name": "Jan",
|
||
"PI Email Address": "medic.kral@centrum.cz",
|
||
"PI Phone Number": "420 605 273 008",
|
||
"Primary Institution Name": "MEDIC KRAL s.r.o.",
|
||
"Site Address": "Lovosicka 440/40, Prague, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Hrabák"
|
||
},
|
||
"excel": {
|
||
"EMA": "UC 1x po náboru, CD 1x v náboru u dr Hrabáka Petr.Hrabak@vfn.cz a +420224962476",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_GJ0A5K2arjVrMLO_b11cOvqU1TI0p3U_CGC_u2vKcBmZVLT23Rf&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Dan",
|
||
"SM poznámky": "12.5. po telefonické domluvě znovu zaslán odkaz na SIPIQ, dnes vyplní, Změna PI na Petr Hrabák",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "On-site 29.5. v 16:00",
|
||
"SIPIQ zajímavosti": "Není na seznamu biol center, ale asi málo IR pacientů má. Zkrácený SIPIQ.",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol?? 5 (4:1) / 4 (3:1)",
|
||
"Počet pacientů SQV": "2 CD + 2 UC pacienty",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Bohate zkusenosti. Primarne naivni pacienti, na Mediconu - endoskopie (nemaji jeste dojednane s Mediconem az po selekci), kompetitivni studie: 2UC + 1CD, vybaveni vse, vendory znaji krome drug dev a safety portalu, 2 SC, SI - Paulen, lekarna dole",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Má zájem o oboje, vyplněno pod Macaskem, zkrácený SIPIQ, počty apcientů nejsou",
|
||
"FINAL DECISION PRO ICONIC IBD": "7-8 z 10 Ano",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "CDA fully signed - PI varianta",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "RECOMMENDED FOR SQV (upravený hlavní zkoušející na Petr HRABAK)",
|
||
"Illumninator status UC": "RECOMMENDED FOR SQV (upravený hlavní zkoušející na Petr HRABAK)",
|
||
"Comment": "Ano, chteji do feasky",
|
||
"Společnost na CDA": "CLINOXUS s.r.o.",
|
||
"PI Last Name": "Hrabák",
|
||
"PI First Name": "Petr",
|
||
"PI Email Address": "jmacasek@seznam.cz",
|
||
"PI Phone Number": "00420 608 677 551",
|
||
"Primary Institution Name": "Clinoxus s.r.o.",
|
||
"Site Address": "Antala Staska 1670/80, Prague, Czechia"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Nabil"
|
||
},
|
||
"excel": {
|
||
"EMA": "CD 1x v náboru- spis dát do Synexu na Karláku",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_ghpIzjlXrPPTAao_b11cOvqU1TI0p3U_CGC_mf5rlJSOn41Zp2c&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Iveta",
|
||
"SM poznámky": "Dr. kontaktován telefoniky 5.5. (604 701 738)",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "26.5. ve 14h-on site",
|
||
"SIPIQ zajímavosti": "Nemá zkušenost s UC ediaries Mayo?, dotazníky, C-SSRS, nevychází počty 15 z 8 pacientů na advanced therapy,",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Biol. dospívající 2 (1:1) /NA",
|
||
"Počet pacientů SQV": "1 az 2 pacienti (1:1}",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Ma omezene zkusenosti. 1-2 pacienty slibil, Site is very interested to be selected for conducting ICONIC IBD-UC (Adolescent):\nThe study team has experience with 2 clinical trials, the site has sufficient equipment and space for conducting\nthe study. All team members are qualified by certificates and experience for this study. The SM recommends\nthe site for participation based on potential subject population, correct staffing and equipment, previous\nexperience in clinical trials and interest in the proposed trial",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Adolescenti",
|
||
"FINAL DECISION PRO ICONIC IBD": "Ano",
|
||
"Adolescenti": "Ano",
|
||
"Stav CDA": "Master CDA hotové",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "approved for feasibility",
|
||
"Illumninator status UC": "approved for feasibility",
|
||
"Comment": "Ano, chtějí do feasky",
|
||
"Společnost na CDA": "MUDr. Nabil El-Lababidi",
|
||
"PI Last Name": "Nabil",
|
||
"PI First Name": "El-Lababidi",
|
||
"PI Email Address": "nabil.el-lababidi@vfn.cz",
|
||
"PI Phone Number": "420 224 967 792 mobil 604 701 738",
|
||
"Primary Institution Name": "VFN"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Kohout"
|
||
},
|
||
"excel": {
|
||
"EMA": "CD 2x po náboru",
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"LTM": "Helena",
|
||
"Comment": "máme prof. Tomáš Hucl",
|
||
"PI Last Name": "Kohout",
|
||
"PI First Name": "Pavel",
|
||
"PI Email Address": "pavel.kohout@ftn.cz",
|
||
"PI Phone Number": "420 261 082 295",
|
||
"Primary Institution Name": "FTN"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Veberova"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_3zF6TQ5R8qTZkXG_b11cOvqU1TI0p3U_CGC_uPztEy4SjGNIdBT&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Nakonec feasku odmitla email 11.5.",
|
||
"SM": "Vlaďka",
|
||
"SM poznámky": "MUDr. Veberová kontaktována přes mobil (704 604 068) 6.5. Slibila že SIPIQ a CDA vyplní zítra",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "N/A",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "20.4. vyžádáno Zuzka , 2.5 zaslána upomínka s návodem, aby CDA podepsala",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "SIPIQ odeslán",
|
||
"Illumninator status UC": "SIPIQ odeslán",
|
||
"Comment": "Ano, chteji do feasky",
|
||
"Společnost na CDA": "MUDr. Lucie Veberová",
|
||
"PI Last Name": "Veberova",
|
||
"PI First Name": "Lucie",
|
||
"PI Email Address": "lucie.veberova@synexus.com; lucie.veberova@globalaes.com",
|
||
"PI Phone Number": "mobil (704 604 068) tel (225 666 111)"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Repak"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "rejected for feasibility",
|
||
"Illumninator status UC": "rejected for feasibility",
|
||
"PI Last Name": "Repak",
|
||
"PI First Name": "Rudolf",
|
||
"PI Email Address": "rrepak@seznam.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Janu"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne jsou vytizeni",
|
||
"PI Last Name": "Janu",
|
||
"PI First Name": "Lubos",
|
||
"PI Email Address": "Lubos.Janu@seznam.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Mináriková"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_SVeZ00mugBfmF2n_b11cOvqU1TI0p3U_CGC_hJh0MEIITJTwJ9Q&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "ano",
|
||
"SM": "Ivetka",
|
||
"SM poznámky": "email ohledně připomenutí vyplnění dotazníku odeslán 7.5.25 a znovu 12.5. na uvn -email adresu. telefonicky neni k zastiženi, sestricka mu předa vzkaz. PI bude Dr. Petra Minarikova-cekám na termín SQV",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "26. 5.",
|
||
"SIPIQ zajímavosti": "Nesedí vůbec počty, není na seznamu biol center, ale asi pacienty mají podle dotrazníku, plus až 1000 pacientu lecenych, ale to nemají ani v pze, Nemá zkusenost s cdai, mayo, csssrs, iata",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 60 (58:60) / 80 (60:75)",
|
||
"Počet pacientů SQV": "2 pacienti UC a 2 pacienti CD",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "The PI has experience with 1 clinical trials, the site has space for conducting the study, hopefully sufficient\nequipment (instead of Stadiometer for measuring height, Incubator for -TBC test) but valid certificates are\nneeded before SIV.\nThe following items for consideration of selection detected:\n • PI has only previous experience with 1 study /12 patients)\n • no previous experience with JJ study and systems\n • contract negotiation and processes can be prolonged 3-5 month\n • There is only 1 SC without back up Additonal comments: The site does not have adolescent patients for ulcerative colitis study; the site addresses only for adult patients\nwith gastrointestinal diseases.\nThe site prefers patient travel reimbursement via direct payment on bank account.\nPI has not CV on EUCTR template.\n PI was also informed about importance sign the following Form before initial study submission incase of\nselection: Conflict of Interest and Centre Suitability.\nSC was informed that all validation/calibration certificates for study equipment needs to be available before SIV",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem oboje, vyplněno pod Gregou, zadáno i 600 a 200 pacientů a pak 800 naivních CD, 200 biol lecba UC a CD",
|
||
"FINAL DECISION PRO ICONIC IBD": "Ne - nema zastup v ambulanci (1PI, 1 SN)",
|
||
"Adolescenti": "Ne",
|
||
"Stav CDA": "PI CDA podepsane",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "RECOMMENDED FOR SQV (upravený hlavní zkoušející na Petra MINARIKOVA)",
|
||
"Illumninator status UC": "RECOMMENDED FOR SQV (upravený hlavní zkoušející na Petra MINARIKOVA)",
|
||
"Comment": "Ano, chteji do feasky",
|
||
"Společnost na CDA": "Ústřední vojenská nemocnice Praha",
|
||
"PI Last Name": "Mináriková",
|
||
"PI First Name": "Petra",
|
||
"PI Email Address": "togrega@gmail.com; petra.minarikova@uvn.cz - poslat feasku v kopii. tomas.grega@uvn.cz",
|
||
"PI Full Address": "973 203 128",
|
||
"Primary Institution Name": "UVN"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Dobesova"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Neni lekar, lekarnice ve fnol",
|
||
"PI Last Name": "Dobesova",
|
||
"PI First Name": "Jarmila",
|
||
"PI Email Address": "jarmila.dobesova@fnol.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Jabandziev"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ano",
|
||
"Adolescenti": "Ano",
|
||
"LTM": "Helena",
|
||
"PI Last Name": "Jabandziev",
|
||
"PI First Name": "Petr",
|
||
"PI Email Address": "jabandziev.petr@fnbrno.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Koskova"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"LTM": "Helena",
|
||
"Comment": "Ne z časových důvodů.",
|
||
"PI Last Name": "Koskova",
|
||
"PI First Name": "Radka",
|
||
"PI Email Address": "studie.endo@seznam.cz'"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
},
|
||
{
|
||
"filter": {
|
||
"prijmeni": "Vaculin"
|
||
},
|
||
"excel": {
|
||
"Centrum BIOLOGICKÉ léčby 52 center (z toho 10 dětských) https://credit.registry": "Ne",
|
||
"Feasibility link. kde je tmavě zelená, je překopírováno do Start up OneNote.": "https://janssenfeasibility.iad1.qualtrics.com/jfe/form/SV_b11cOvqU1TI0p3U?Q_CHL=gl&Q_DL=EMD_NLDs24bHQ6HIhn9_b11cOvqU1TI0p3U_CGC_0fkLHPcQggr14cR&_g_=g",
|
||
"Feasibility dotaznik vyplnen": "Ano",
|
||
"SM": "Žaneta",
|
||
"SM poznámky": "6.5.2025 nepodařilo se mi dovolat,zkoušela jsem x krát. Poslala jsem upomínku emailem. 26.5.2025 ozval se pan Matějovský z Efertusu, dal mi termín SQV.",
|
||
"Termín SQV a TYP (onsite či remote, respektive remote)": "28. 5. 2025 remotely",
|
||
"SIPIQ zajímavosti": "nevyhcází počty, navíc jako nebiol centrum. Zkrácený SIPIQ ok???",
|
||
"Počet pacientů SIPIQ UC/CD (naive:IR)": "Nebiol. 15 (8:12) / 10 (7:8)",
|
||
"Počet pacientů SQV": "CD 3 / UC 3",
|
||
"Recommended Not recommended for selection argumenty podle reportu": "Vaculin nikdy nebyl PI, ale vzdy SI. Vic mluvil Efertus SC. Nemaji mrazak a lednici. Vybaveni maji. Recommended, ale figuruje tam Efertus-nevím zda nebude problém se smlouvou, chtějí 4 strannou (Janssen/GastroNell/Efertus/PI) Koordinátor z Efertus bude hodně akční,komunikace bude dobrá. PI je poprvé PI, dříve vždy SI. PI je tišší povahy, během SQV mluvil spíše koordinátor. Po SQV PI rychle reagoval na emaily-snad bude komunikace dobrá.",
|
||
"Zájem o Jnj4804 podle SIPIQ a jejich rozložení pacientů podle SIPIQ pro další ro": "Mají zájem o oboje. Počty pacientů nejsou, je zkrácený SIPIQ.",
|
||
"FINAL DECISION PRO ICONIC IBD": "Spis ne kvuli smlouve, 6-7 z 10",
|
||
"Adolescenti": "ne",
|
||
"Stav CDA": "CDA fully signed - PI varianta",
|
||
"LTM": "Helena",
|
||
"Illuminator status CD": "máme SIPIQ",
|
||
"Illumninator status UC": "máme SIPIQ",
|
||
"Comment": "Ano, chteji do feasky",
|
||
"Společnost na CDA": "Vsetín",
|
||
"PI Last Name": "Vaculin",
|
||
"PI First Name": "Vladimir",
|
||
"PI Email Address": "endovsetin@seznam.cz"
|
||
},
|
||
"zdroj_sheet": "IBD LIST OF SITES"
|
||
}
|
||
]
|
||
|
||
FIXES = {
|
||
'Šuláková': 'Sulakova',
|
||
'Hucl/Drastich': 'Drastich',
|
||
'Vyhnálek': 'Vyhnalek',
|
||
'Šerclová': 'Serclova',
|
||
'Pumprla jr.': 'Pumprla',
|
||
'Koželuhová': 'Kozeluhova',
|
||
'Košková': 'Koskova',
|
||
'Král': 'Kral',
|
||
'Hrabák': 'Hrabak',
|
||
'Nabil': 'El Lababidi',
|
||
'Mináriková': 'Minarikova',
|
||
}
|
||
|
||
ok = 0
|
||
skip = 0
|
||
for u in updates:
|
||
p = u["filter"]["prijmeni"]
|
||
if p in FIXES:
|
||
u["filter"]["prijmeni"] = FIXES[p]
|
||
result = col.update_one(u["filter"], {"$set": {"excel": u["excel"]}})
|
||
if result.matched_count:
|
||
ok += 1
|
||
else:
|
||
skip += 1
|
||
print(f" Nenalezen: {u['filter']}")
|
||
|
||
print(f"Aktualizováno: {ok}, nenalezeno: {skip}")
|
||
client.close()
|