diff --git a/CTMS/VisitsFromCTMSExport/10_explore_data.py b/CTMS/VisitsFromCTMSExport/10_explore_data.py new file mode 100644 index 0000000..8bab6e6 --- /dev/null +++ b/CTMS/VisitsFromCTMSExport/10_explore_data.py @@ -0,0 +1,47 @@ +import pandas as pd + +CSV_FILE = "filename.csv" + +df = pd.read_csv(CSV_FILE, sep=";", encoding="utf-8-sig") + +# Parse dates +date_cols = ["Original Due Date", "Due Date", "Window Start Date", "Cutoff Date", "Completed Date"] +for col in date_cols: + df[col] = pd.to_datetime(df[col], errors="coerce") + +# Country from site number +df["Country"] = df["Study Site Number"].str.extract(r"DD5-([A-Z]+)\d+") + +print("=" * 60) +print("CTMS VISITS EXPORT — přehled dat") +print("=" * 60) +print(f"\nCelkem řádků : {len(df):,}") +print(f"Celkem sloupců: {len(df.columns)}") +print(f"\nSloupce:\n " + "\n ".join(df.columns.tolist())) + +print(f"\nSites celkem : {df['Study Site Number'].nunique()}") +print(f"Zemí celkem : {df['Country'].nunique()}") +print(f"Země : {', '.join(sorted(df['Country'].dropna().unique()))}") + +print("\nStatus:") +for k, v in df["Status"].value_counts().items(): + print(f" {k:<20} {v:>6,}") + +print("\nCategory:") +for k, v in df["Category"].value_counts().items(): + print(f" {k:<25} {v:>6,}") + +print("\nSub Category:") +for k, v in df["Sub Category"].value_counts().items(): + print(f" {k:<20} {v:>6,}") + +print(f"\nReference kódy: {sorted(df['Reference'].dropna().unique().tolist())}") + +print("\nRozsah dat:") +for col in ["Due Date", "Completed Date"]: + vals = df[col].dropna() + if len(vals): + print(f" {col:<20} {vals.min().date()} — {vals.max().date()}") + +print("\nNáhled (5 řádků):") +print(df.head(5).to_string()) diff --git a/CTMS/VisitsFromCTMSExport/20_report_CZ.py b/CTMS/VisitsFromCTMSExport/20_report_CZ.py new file mode 100644 index 0000000..24f560c --- /dev/null +++ b/CTMS/VisitsFromCTMSExport/20_report_CZ.py @@ -0,0 +1,401 @@ +import pandas as pd +import openpyxl +from openpyxl.styles import Font, PatternFill, Alignment, Border, Side, numbers +from openpyxl.utils import get_column_letter +from datetime import date +import os + +CSV_FILE = "filename.csv" +SVR_FILE = "Site Visit Report (2).xlsx" +OUTPUT_DIR = os.path.join("..", "..", "CTMS", "output") +os.makedirs(OUTPUT_DIR, exist_ok=True) +today_str = date.today().strftime("%Y-%m-%d") +OUTPUT_FILE = os.path.join(OUTPUT_DIR, f"{today_str} UCO3001 CZ CTMS Visits.xlsx") + +# --- Load & filter --- +df = pd.read_csv(CSV_FILE, sep=";", encoding="utf-8-sig") +df["Country"] = df["Study Site Number"].str.extract(r"DD5-([A-Z]+)\d+") +cz = df[df["Country"] == "CZ"].copy() + +date_cols = ["Original Due Date", "Due Date", "Window Start Date", "Cutoff Date", "Completed Date"] +for col in date_cols: + cz[col] = pd.to_datetime(cz[col], errors="coerce") + +SITES = [ + "DD5-CZ10001", "DD5-CZ10003", "DD5-CZ10006", "DD5-CZ10009", + "DD5-CZ10010", "DD5-CZ10012", "DD5-CZ10013", "DD5-CZ10015", + "DD5-CZ10016", "DD5-CZ10020", "DD5-CZ10021", "DD5-CZ10022", +] +cz = cz[cz["Study Site Number"].isin(SITES) & cz["Status"].isin(["Completed", "Scheduled", "Planned"])].copy() + +cz["CRA"] = cz["Assigned To Last Name"].fillna("") + +# --- Merge Site Visit Report (2) --- +import re as _re +def _svid_to_ref(svid): + svid = str(svid).replace("MCTMS|", "") + if svid == "Qualification Visit": return "SQV" + if svid == "Site Initiation": return "SIV" + if svid == "Closure Visit": return "COV" + m = _re.match(r"Monitoring Visit (\d+)", svid) + return f"IMV{m.group(1)}" if m else svid + +svr = pd.read_excel(SVR_FILE, header=5) +svr = svr[svr["Site ID"].isin(SITES)].copy() +svr["Reference"] = svr["Site Visit ID"].apply(_svid_to_ref) +svr = svr[["Site ID", "Reference", "Site Visit Type", "Submitter Name", "Approver Name"]].rename(columns={"Site ID": "Study Site Number"}) + +cz = cz.merge(svr, on=["Study Site Number", "Reference"], how="left") + +# --- Styles --- +FONT_NAME = "Arial" +COL_HEADER = "1F5C99" # dark blue +COL_COMPL = "E2EFDA" # light green +COL_SCHED = "FFF2CC" # light yellow +COL_PLAN = "FCE4D6" # light orange +COL_NA = "F2F2F2" # grey +WHITE = "FFFFFF" +DARK_TEXT = "000000" + +STATUS_COLORS = { + "Completed": COL_COMPL, + "Scheduled": COL_SCHED, + "Planned": COL_PLAN, + "Not applicable": COL_NA, +} + +thin = Side(style="thin", color="BFBFBF") +med = Side(style="medium", color="808080") + +def border(left=thin, right=thin, top=thin, bottom=thin): + return Border(left=left, right=right, top=top, bottom=bottom) + +def header_cell(ws, row, col, value, width=None): + c = ws.cell(row=row, column=col, value=value) + c.font = Font(name=FONT_NAME, bold=True, color=WHITE, size=10) + c.fill = PatternFill("solid", fgColor=COL_HEADER) + c.alignment = Alignment(horizontal="center", vertical="center", wrap_text=True) + c.border = Border(left=Side(style="medium", color=WHITE), + right=Side(style="medium", color=WHITE), + top=thin, bottom=thin) + if width and col <= ws.max_column or width: + ws.column_dimensions[get_column_letter(col)].width = width + return c + +def data_cell(ws, row, col, value, fill_color=WHITE, align="left", bold=False, num_fmt=None, date_val=False): + c = ws.cell(row=row, column=col, value=value) + c.font = Font(name=FONT_NAME, size=9, bold=bold, color=DARK_TEXT) + if fill_color != WHITE: + c.fill = PatternFill("solid", fgColor=fill_color) + c.alignment = Alignment(horizontal=align, vertical="center") + c.border = border() + if num_fmt: + c.number_format = num_fmt + elif date_val and isinstance(value, (pd.Timestamp, type(None))): + c.number_format = "DD-MMM-YYYY" + return c + +# ========================================================= +# SHEET 1: Přehled per site +# ========================================================= +wb = openpyxl.Workbook() +ws1 = wb.active +ws1.title = "Přehled CZ" +ws1.freeze_panes = "A3" + +# Title +ws1.merge_cells("A1:M1") +title = ws1["A1"] +title.value = f"UCO3001 — CZ CTMS Visits Overview | {today_str}" +title.font = Font(name=FONT_NAME, bold=True, size=12, color=WHITE) +title.fill = PatternFill("solid", fgColor="2E4057") +title.alignment = Alignment(horizontal="center", vertical="center") +ws1.row_dimensions[1].height = 22 + +# Headers +headers = [ + ("Site", 14), ("Investigátor", 22), + ("SQV", 11), ("SIV", 11), + ("IMV\nCompleted", 11), ("IMV\nScheduled", 11), ("IMV\nPlanned", 11), + ("COV", 11), + ("Poslední vizita\nDatum", 14), ("Poslední vizita\nTyp", 16), + ("Příští vizita\nDatum", 14), ("Příští vizita\nTyp", 16), + ("Celkem\nvizit", 10), +] +for ci, (h, w) in enumerate(headers, 1): + header_cell(ws1, 2, ci, h, width=w) +ws1.row_dimensions[2].height = 30 + +# Data per site +sites = sorted(cz["Study Site Number"].unique()) +for ri, site in enumerate(sites, 3): + s = cz[cz["Study Site Number"] == site] + inv_row = s.iloc[0] + inv = f"{inv_row['INV_FIRST_NAME']} {inv_row['INV_LAST_NAME']}" + cra = s["CRA"].replace("", pd.NA).dropna().iloc[0] if not s["CRA"].replace("", pd.NA).dropna().empty else "" + + sqv = s[s["Reference"] == "SQV"] + siv = s[s["Reference"] == "SIV"] + cov = s[s["Reference"] == "COV"] + imv = s[s["Category"] == "Monitoring Visit"] + + def visit_status(sub): + if sub.empty: + return ("—", COL_NA) + st = sub.iloc[0]["Status"] + return (st, STATUS_COLORS.get(st, WHITE)) + + sqv_st, sqv_c = visit_status(sqv) + siv_st, siv_c = visit_status(siv) + cov_st, cov_c = visit_status(cov) + + imv_comp = int((imv["Status"] == "Completed").sum()) + imv_sch = int((imv["Status"] == "Scheduled").sum()) + imv_plan = int((imv["Status"] == "Planned").sum()) + + # Last completed + comp = s[s["Status"] == "Completed"].dropna(subset=["Completed Date"]) + last_comp = comp.sort_values("Completed Date").iloc[-1] if not comp.empty else None + last_date = last_comp["Completed Date"] if last_comp is not None else None + last_type = last_comp["Reference"] if last_comp is not None else "—" + + # Next upcoming — pouze vizity s Due Date po poslední Completed + upcoming = s[s["Status"].isin(["Scheduled", "Planned"])].dropna(subset=["Due Date"]) + if last_date is not None: + upcoming = upcoming[upcoming["Due Date"] > last_date] + next_vis = upcoming.sort_values("Due Date").iloc[0] if not upcoming.empty else None + next_date = next_vis["Due Date"] if next_vis is not None else None + next_type = next_vis["Reference"] if next_vis is not None else "—" + + total = len(s) + bg = WHITE if ri % 2 == 0 else "F7F9FC" + + row_data = [ + (site, "left", True, None, None), + (inv, "left", False, None, None), + (sqv_st, "center", False, None, sqv_c), + (siv_st, "center", False, None, siv_c), + (imv_comp, "center", False, "#,##0", None), + (imv_sch, "center", False, "#,##0", None), + (imv_plan, "center", False, "#,##0", None), + (cov_st, "center", False, None, cov_c), + (last_date, "center", False, "DD-MMM-YY",None), + (last_type, "center", False, None, None), + (next_date, "center", False, "DD-MMM-YY",None), + (next_type, "center", False, None, None), + (total, "center", True, "#,##0", None), + ] + for ci, (val, align, bold, fmt, fill) in enumerate(row_data, 1): + fc = fill if fill else bg + c = data_cell(ws1, ri, ci, val, fill_color=fc, align=align, bold=bold) + if fmt: + c.number_format = fmt + ws1.row_dimensions[ri].height = 16 + +# Autofilter +ws1.auto_filter.ref = f"A2:{get_column_letter(len(headers))}2" + +# ========================================================= +# SHEET 2: Detail všech CZ vizit +# ========================================================= +ws2 = wb.create_sheet("Detail CZ") +ws2.freeze_panes = "A3" + +ws2.merge_cells("A1:N1") +t2 = ws2["A1"] +t2.value = f"UCO3001 — CZ CTMS Visits — Detail | {today_str}" +t2.font = Font(name=FONT_NAME, bold=True, size=12, color=WHITE) +t2.fill = PatternFill("solid", fgColor="2E4057") +t2.alignment = Alignment(horizontal="center", vertical="center") +ws2.row_dimensions[1].height = 22 + +det_headers = [ + ("Site", 14), ("Investigátor", 22), ("CRA (Submitter)", 24), + ("Ref", 9), ("Název vizity", 24), ("Category", 20), ("Sub Category", 16), + ("Status", 14), + ("Due Date", 13), ("Window Start", 13), ("Cutoff Date", 13), ("Completed Date", 13), + ("Typ vizity", 12), +] +for ci, (h, w) in enumerate(det_headers, 1): + header_cell(ws2, 2, ci, h, width=w) +ws2.row_dimensions[2].height = 26 + +# Sort: site → SQV → SIV → IMV1 → IMV2 … → COV +ref_order = {"SQV": 0, "SIV": 1, "COV": 9999} +def ref_sort_key(ref): + if ref in ref_order: + return ref_order[ref] + import re + m = re.match(r"IMV(\d+)$", str(ref)) + return int(m.group(1)) + 1 if m else 5000 +cz["_ref_ord"] = cz["Reference"].apply(ref_sort_key) +detail = cz.sort_values(["Study Site Number", "_ref_ord"]).reset_index(drop=True) + +for ri, row in detail.iterrows(): + r = ri + 3 + st = row["Status"] + bg = STATUS_COLORS.get(st, WHITE) + + inv = f"{row['INV_FIRST_NAME']} {row['INV_LAST_NAME']}" + submitter = row["Submitter Name"] if pd.notna(row.get("Submitter Name")) else "" + visit_type = row["Site Visit Type"] if pd.notna(row.get("Site Visit Type")) else "" + vals = [ + (row["Study Site Number"], "left", True), + (inv, "left", False), + (submitter, "left", False), + (row["Reference"], "center", True), + (row["Visit Name"], "left", False), + (row["Category"], "left", False), + (row["Sub Category"], "left", False), + (st, "center", False), + (row["Due Date"], "center", False), + (row["Window Start Date"], "center", False), + (row["Cutoff Date"], "center", False), + (row["Completed Date"], "center", False), + (visit_type, "center", False), + ] + for ci, (val, align, bold) in enumerate(vals, 1): + c = data_cell(ws2, r, ci, val, fill_color=bg, align=align, bold=bold) + if isinstance(val, pd.Timestamp) and not pd.isna(val): + c.value = val.to_pydatetime() + c.number_format = "DD-MMM-YY" + ws2.row_dimensions[r].height = 14 + +ws2.auto_filter.ref = f"A2:{get_column_letter(len(det_headers))}2" + +# ========================================================= +# SHEET 3: Nadcházející / Scheduled+Planned +# ========================================================= +ws3 = wb.create_sheet("Nadcházející vizity") +ws3.freeze_panes = "A3" + +ws3.merge_cells("A1:J1") +t3 = ws3["A1"] +t3.value = f"UCO3001 — CZ — Nadcházející vizity (Scheduled + Planned) | {today_str}" +t3.font = Font(name=FONT_NAME, bold=True, size=12, color=WHITE) +t3.fill = PatternFill("solid", fgColor="2E4057") +t3.alignment = Alignment(horizontal="center", vertical="center") +ws3.row_dimensions[1].height = 22 + +upc_headers = [ + ("Due Date", 13), ("Site", 14), ("Investigátor", 22), ("CRA", 14), + ("Ref", 9), ("Název vizity", 24), ("Category", 20), + ("Status", 12), ("Window Start", 13), ("Cutoff Date", 13), +] +for ci, (h, w) in enumerate(upc_headers, 1): + header_cell(ws3, 2, ci, h, width=w) +ws3.row_dimensions[2].height = 26 + +upcoming = cz[cz["Status"].isin(["Scheduled", "Planned"])].sort_values(["Due Date", "Study Site Number"]).reset_index(drop=True) + +for ri, row in upcoming.iterrows(): + r = ri + 3 + bg = STATUS_COLORS.get(row["Status"], WHITE) + inv = f"{row['INV_FIRST_NAME']} {row['INV_LAST_NAME']}" + vals = [ + (row["Due Date"], "center", True), + (row["Study Site Number"], "left", False), + (inv, "left", False), + (row["CRA"], "center", False), + (row["Reference"], "center", True), + (row["Visit Name"], "left", False), + (row["Category"], "left", False), + (row["Status"], "center", False), + (row["Window Start Date"], "center", False), + (row["Cutoff Date"], "center", False), + ] + for ci, (val, align, bold) in enumerate(vals, 1): + c = data_cell(ws3, r, ci, val, fill_color=bg, align=align, bold=bold) + if isinstance(val, pd.Timestamp) and not pd.isna(val): + c.value = val.to_pydatetime() + c.number_format = "DD-MMM-YY" + ws3.row_dimensions[r].height = 14 + +ws3.auto_filter.ref = f"A2:{get_column_letter(len(upc_headers))}2" + +# ========================================================= +# SHEET 4: Problémy — datové nesoulady +# ========================================================= +ws4 = wb.create_sheet("Problémy") +ws4.freeze_panes = "A3" + +# Načteme původní data bez statusového filtru pro detekci problémů +df_raw = pd.read_csv(CSV_FILE, sep=";", encoding="utf-8-sig") +df_raw["Country"] = df_raw["Study Site Number"].str.extract(r"DD5-([A-Z]+)\d+") +cz_raw = df_raw[df_raw["Study Site Number"].isin(SITES)].copy() +for col in date_cols: + cz_raw[col] = pd.to_datetime(cz_raw[col], errors="coerce") +cz_raw["CRA"] = cz_raw["Assigned To Last Name"].fillna("") +cz_raw = cz_raw.merge(svr, on=["Study Site Number", "Reference"], how="left") +cz_raw["Submitter Name"] = cz_raw["Submitter Name"].fillna("") + +problems = [] + +# Pravidlo 1: Completed Date vyplněno ale Status ≠ Completed +mask1 = cz_raw["Completed Date"].notna() & (cz_raw["Status"] != "Completed") +for _, row in cz_raw[mask1].iterrows(): + problems.append((row, "Completed Date je vyplněno, ale Status není Completed")) + +# Seřadit podle site a reference +import re as _re +def _ref_key(ref): + if ref == "SQV": return 0 + if ref == "SIV": return 1 + if ref == "COV": return 9999 + m = _re.match(r"IMV(\d+)$", str(ref)) + return int(m.group(1)) + 1 if m else 5000 + +problems.sort(key=lambda x: (x[0]["Study Site Number"], _ref_key(x[0]["Reference"]))) + +COL_PROBLEM = "FFC7CE" # světle červená + +ws4.merge_cells("A1:M1") +t4 = ws4["A1"] +t4.value = f"UCO3001 — CZ — Datové problémy k opravě v OneCTMS | {today_str}" +t4.font = Font(name=FONT_NAME, bold=True, size=12, color=WHITE) +t4.fill = PatternFill("solid", fgColor="C00000") +t4.alignment = Alignment(horizontal="center", vertical="center") +ws4.row_dimensions[1].height = 22 + +prob_headers = [ + ("Site", 14), ("Investigátor", 22), ("CRA (Submitter)", 24), + ("Ref", 9), ("Název vizity", 24), ("Category", 18), + ("Status", 14), + ("Due Date", 13), ("Completed Date", 13), + ("", 2), + ("Důvod — co je potřeba opravit v OneCTMS", 50), +] +for ci, (h, w) in enumerate(prob_headers, 1): + header_cell(ws4, 2, ci, h, width=w) +ws4.row_dimensions[2].height = 26 + +for ri, (row, reason) in enumerate(problems, 3): + inv = f"{row['INV_FIRST_NAME']} {row['INV_LAST_NAME']}" + vals = [ + (row["Study Site Number"], "left", True, None), + (inv, "left", False, None), + (row["Submitter Name"], "left", False, None), + (row["Reference"], "center", True, None), + (row["Visit Name"], "left", False, None), + (row["Category"], "left", False, None), + (row["Status"], "center", False, None), + (row["Due Date"], "center", False, "DD-MMM-YY"), + (row["Completed Date"], "center", False, "DD-MMM-YY"), + ("", "center", False, None), + (reason, "left", True, None), + ] + for ci, (val, align, bold, fmt) in enumerate(vals, 1): + c = data_cell(ws4, ri, ci, val, fill_color=COL_PROBLEM, align=align, bold=bold) + if fmt and isinstance(val, pd.Timestamp) and not pd.isna(val): + c.value = val.to_pydatetime() + c.number_format = fmt + ws4.row_dimensions[ri].height = 16 + +ws4.auto_filter.ref = f"A2:{get_column_letter(len(prob_headers))}2" + +wb.save(OUTPUT_FILE) +print(f"Report uložen: {OUTPUT_FILE}") +print(f" Sheet 'Přehled CZ' : {len(sites)} sites") +print(f" Sheet 'Detail CZ' : {len(detail)} řádků") +print(f" Sheet 'Nadcházející vizity': {len(upcoming)} vizit") +print(f" Sheet 'Problémy' : {len(problems)} záznamů") diff --git a/CTMS/VisitsFromCTMSExport/NOTES.md b/CTMS/VisitsFromCTMSExport/NOTES.md new file mode 100644 index 0000000..da3424d --- /dev/null +++ b/CTMS/VisitsFromCTMSExport/NOTES.md @@ -0,0 +1,44 @@ +# OneCTMS — Visit Schedule Notes + +## Zdroj +LTM Local Trial Manager OneCTMS Manual, ver. 11.0, 15-Dec-2024 (stránky 11–28) + +## Statusy vizit + +| Status | Popis | +|---|---| +| **Planned** | Vizita existuje v harmonogramu, SM zatím nezadal Visit Start Date. Dropdown nabídka jej obsahuje, ale manuál jeho použití na str. 11–28 blíže nevysvětluje. | +| **Scheduled** | SM zadal Visit Start Date → datum se automaticky propíše do ATLAS jako "Next Scheduled Visit Date". | +| **Completed** | SM označil vizitu za dokončenou. | +| **Not applicable** | Nevyužitý placeholder — prázdný slot ze DSM šablony (výchozích 50 MV). Nemá vypovídací hodnotu, filtrujeme ven. | + +Přechod stavů dle manuálu (str. 24): +``` +Planned → Scheduled → Completed +``` + +## DSM specifika (studie UCO3001) + +- Studie používá **Dynamic Site Monitoring (DSM)** — šablona SIV + SCV + 50 MV s 8týdenními intervaly. +- **Due Date se v DSM nepoužívá pro řazení** — vizity se řadí podle číselné sekvence (IMV1, IMV2, ...). +- Správné pořadí vizit: **SQV → SIV → IMV1 → IMV2 → … → COV** +- `Not applicable` vizity jsou nevyužité sloty šablony → vyřadit z reportů a počtů. +- `Planned` vizity jsou reálné budoucí vizity bez potvrzeného data → ponechat. + +## Zdrojové soubory + +| Soubor | Systém | Odkud | +|---|---|---| +| `filename.csv` | **OneCTMS** | modul Visits → EMEA export (středníkový CSV) | +| `Site Visit Report (2).xlsx` | **VIPER** | SVR Metrics report | + +`filename.csv` obsahuje harmonogram vizit (plánované i completed), ale pole Assigned To je vyplněno nesystematicky — nelze spolehlivě použít jako zdroj CRA. + +`Site Visit Report (2).xlsx` obsahuje pouze vizity se schváleným reportem (SVR Status = Reviewed and Approved), ale má klíčové pole **Submitter Name** = kdo vizitu reálně provedl. Oba soubory se propojují přes Site ID + Reference (SQV/SIV/IMV1...). + +## Report skript + +`20_report_CZ.py` — generuje Excel report pro 12 CZ center (Buzalka/Cetkovská porfolio): +- Sheet **Přehled CZ** — souhrn per site +- Sheet **Detail CZ** — všechny vizity, řazeno SQV→SIV→IMV1…→COV +- Sheet **Nadcházející vizity** — Scheduled + Planned seřazeno dle Due Date diff --git a/CTMS/output/2026-04-27 UCO3001 CZ CTMS Visits.xlsx b/CTMS/output/2026-04-27 UCO3001 CZ CTMS Visits.xlsx new file mode 100644 index 0000000..bdd662b Binary files /dev/null and b/CTMS/output/2026-04-27 UCO3001 CZ CTMS Visits.xlsx differ diff --git a/CTMS/output/Protocol/D1_m25540-protocol-redacted.PDF b/CTMS/output/Protocol/D1_m25540-protocol-redacted.PDF new file mode 100644 index 0000000..87a92c2 Binary files /dev/null and b/CTMS/output/Protocol/D1_m25540-protocol-redacted.PDF differ diff --git a/CTMS/output/Protocol/D4_Patient facing documents-Placeholder_SK.PDF b/CTMS/output/Protocol/D4_Patient facing documents-Placeholder_SK.PDF new file mode 100644 index 0000000..ef5a312 Binary files /dev/null and b/CTMS/output/Protocol/D4_Patient facing documents-Placeholder_SK.PDF differ diff --git a/CTMS/output/Protocol/D4_Patient facing documents-Public.PDF b/CTMS/output/Protocol/D4_Patient facing documents-Public.PDF new file mode 100644 index 0000000..ef5a312 Binary files /dev/null and b/CTMS/output/Protocol/D4_Patient facing documents-Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/K1_M25-540_AT_Recruitment and ICF Procedures_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/K1_M25-540_AT_Recruitment and ICF Procedures_public.PDF new file mode 100644 index 0000000..96a462d Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/K1_M25-540_AT_Recruitment and ICF Procedures_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_ AT_ICF Main_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_ AT_ICF Main_public.PDF new file mode 100644 index 0000000..962e7d8 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_ AT_ICF Main_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_AT_Blank document_ICF site contact details_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_AT_Blank document_ICF site contact details_public.PDF new file mode 100644 index 0000000..aaf628b Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Austria/L1_M25-540_AT_Blank document_ICF site contact details_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/K1_M25-540 BG Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/K1_M25-540 BG Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..fba0b0a Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/K1_M25-540 BG Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined Bulgarian_Public redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined Bulgarian_Public redacted.PDF new file mode 100644 index 0000000..829904c Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined Bulgarian_Public redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Public Redacted.PDF new file mode 100644 index 0000000..7272e55 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Track changes.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Track changes.PDF new file mode 100644 index 0000000..19f538a Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Bulgaria/L1_M25-540 BG ICF Combined English_Track changes.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/K1_M25-540 HR Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/K1_M25-540 HR Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..6de2217 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/K1_M25-540 HR Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Main_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Main_Public.PDF new file mode 100644 index 0000000..5fa8ff0 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Main_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Optional_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Optional_Public.PDF new file mode 100644 index 0000000..8a443a8 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Optional_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Pregnant Subject_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Pregnant Subject_Public.PDF new file mode 100644 index 0000000..b712757 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Croatia/L1_M25-540 HR ICF Pregnant Subject_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/K1 M25-540 CZ Recruitment and ICF Procedures.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/K1 M25-540 CZ Recruitment and ICF Procedures.PDF new file mode 100644 index 0000000..1482027 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/K1 M25-540 CZ Recruitment and ICF Procedures.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ Confidentiality and data protection Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ Confidentiality and data protection Public.PDF new file mode 100644 index 0000000..53e7fa6 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ Confidentiality and data protection Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Main Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Main Public.PDF new file mode 100644 index 0000000..84892ac Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Main Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Optional Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Optional Public.PDF new file mode 100644 index 0000000..a71776d Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF Optional Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF PTE Addendum Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF PTE Addendum Public.PDF new file mode 100644 index 0000000..662f2aa Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Czechia/L1 M25-540 CZ ICF PTE Addendum Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/K1_M25-540_EE_Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/K1_M25-540_EE_Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..0d0f189 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/K1_M25-540_EE_Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Estonian_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Estonian_Public.PDF new file mode 100644 index 0000000..78033ac Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Estonian_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Russian_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Russian_Public.PDF new file mode 100644 index 0000000..d754294 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Estonia/L1_M25-540_EE_ICF Main_Russian_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/K1 M25-540 FI Recruitment and ICF Procedures_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/K1 M25-540 FI Recruitment and ICF Procedures_public.PDF new file mode 100644 index 0000000..f078f41 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/K1 M25-540 FI Recruitment and ICF Procedures_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/L1 M25-540 FI Main ICF_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/L1 M25-540 FI Main ICF_Public.PDF new file mode 100644 index 0000000..0724263 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Finland/L1 M25-540 FI Main ICF_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/K1 M25-540 FR Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/K1 M25-540 FR Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..faead29 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/K1 M25-540 FR Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF.PDF new file mode 100644 index 0000000..3fbefd2 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF_TrackChanges.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF_TrackChanges.PDF new file mode 100644 index 0000000..4b83760 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Addendum Main ICF_TrackChanges.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Main ICF.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Main ICF.PDF new file mode 100644 index 0000000..385c8a8 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Main ICF.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Optional research ICF.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Optional research ICF.PDF new file mode 100644 index 0000000..cf1180f Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Optional research ICF.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF.PDF new file mode 100644 index 0000000..0359df5 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF_Track Changes.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF_Track Changes.PDF new file mode 100644 index 0000000..b5e7f74 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/France/L1 M25-540 FR Pregnant Participant ICF_Track Changes.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/K1_M25-540_DE_Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/K1_M25-540_DE_Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..07a4889 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/K1_M25-540_DE_Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE ICF Pregnancy_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE ICF Pregnancy_Public.PDF new file mode 100644 index 0000000..fc14c29 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE ICF Pregnancy_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE_ICF Main_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE_ICF Main_Public Redacted.PDF new file mode 100644 index 0000000..9a29316 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Germany/L1_M25-540_DE_ICF Main_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/K1 M25-540 HU Recruitment and ICF Procedures Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/K1 M25-540 HU Recruitment and ICF Procedures Public.PDF new file mode 100644 index 0000000..904bbcc Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/K1 M25-540 HU Recruitment and ICF Procedures Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU Main ICF Public redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU Main ICF Public redacted.PDF new file mode 100644 index 0000000..e9c9f2a Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU Main ICF Public redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker ICF Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker ICF Public.PDF new file mode 100644 index 0000000..fc94b83 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker ICF Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker PIS Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker PIS Public.PDF new file mode 100644 index 0000000..40dc6d7 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L1 M25-540 HU PGen OptGen and Biomarker PIS Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L2 M25-540 HU EU-CTR blank document Subject Participation Card Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L2 M25-540 HU EU-CTR blank document Subject Participation Card Public.PDF new file mode 100644 index 0000000..33d7fb4 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Hungary/L2 M25-540 HU EU-CTR blank document Subject Participation Card Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/K1 M25-540 IE Recruitment and ICF Procedures Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/K1 M25-540 IE Recruitment and ICF Procedures Public.PDF new file mode 100644 index 0000000..7130dd7 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/K1 M25-540 IE Recruitment and ICF Procedures Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Continued Treatment PUBLIC.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Continued Treatment PUBLIC.PDF new file mode 100644 index 0000000..c8fd173 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Continued Treatment PUBLIC.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Main Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Main Public Redacted.PDF new file mode 100644 index 0000000..ce2ccff Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Ireland/L1 M25-540 IE ICF Main Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/K1_M25-540 IT Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/K1_M25-540 IT Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..8451597 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/K1_M25-540 IT Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Public Redacted.PDF new file mode 100644 index 0000000..b7b16d2 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Redline.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Redline.PDF new file mode 100644 index 0000000..b6929b0 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT ICF Combined_Redline.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT PTE_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT PTE_Public.PDF new file mode 100644 index 0000000..f851143 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT PTE_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT Pregnancy_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT Pregnancy_Public.PDF new file mode 100644 index 0000000..2e8499d Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Italy/L1_M25-540 IT Pregnancy_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/K1_M25-540_LV_Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/K1_M25-540_LV_Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..5cc7568 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/K1_M25-540_LV_Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Latvian_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Latvian_Public.PDF new file mode 100644 index 0000000..7d37f34 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Latvian_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Russian_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Russian_Public.PDF new file mode 100644 index 0000000..4be8b5d Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Latvia/L1_M25-540_LV_ICF Main_Russian_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/K1_M25-540_LT_Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/K1_M25-540_LT_Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..f77aaca Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/K1_M25-540_LT_Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Main_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Main_Public.PDF new file mode 100644 index 0000000..d9984bd Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Main_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Optional_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Optional_Public.PDF new file mode 100644 index 0000000..b652726 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Lithuania/L1_M25-540_LT_ICF Optional_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/K1_M25-540 NL Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/K1_M25-540 NL Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..50eadf6 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/K1_M25-540 NL Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1 M25-540 NL ICF Cont Treatment_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1 M25-540 NL ICF Cont Treatment_Public.PDF new file mode 100644 index 0000000..b1d54a9 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1 M25-540 NL ICF Cont Treatment_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1_M25-540 NL ICF Main_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1_M25-540 NL ICF Main_Public Redacted.PDF new file mode 100644 index 0000000..7ee6fa1 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Netherlands/L1_M25-540 NL ICF Main_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/K1 M25-540 PL Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/K1 M25-540 PL Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..5db0c72 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/K1 M25-540 PL Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Main_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Main_Public Redacted.PDF new file mode 100644 index 0000000..a750ba3 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Main_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Optional_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Optional_Public.PDF new file mode 100644 index 0000000..7ee3b90 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Optional_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Pregnancy_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Pregnancy_Public.PDF new file mode 100644 index 0000000..f9ec453 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Poland/L1 M25-540 PL ICF Pregnancy_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/K1_M25-540 RO Recruitment and ICF Procedures.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/K1_M25-540 RO Recruitment and ICF Procedures.PDF new file mode 100644 index 0000000..1ced256 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/K1_M25-540 RO Recruitment and ICF Procedures.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main English_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main English_Public Redacted.PDF new file mode 100644 index 0000000..5635d24 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main English_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main Romanian_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main Romanian_Public Redacted.PDF new file mode 100644 index 0000000..73866bd Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF Main Romanian_Public Redacted.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum English_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum English_Public.PDF new file mode 100644 index 0000000..44dcf5a Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum English_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum Romanian_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum Romanian_Public.PDF new file mode 100644 index 0000000..92889b0 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Romania/L1_M25-540 RO ICF PTE Addendum Romanian_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/K1 M25-540 SK Recruitment and ICF Procedures.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/K1 M25-540 SK Recruitment and ICF Procedures.PDF new file mode 100644 index 0000000..7efd68d Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/K1 M25-540 SK Recruitment and ICF Procedures.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK Confidentiality and data protection.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK Confidentiality and data protection.PDF new file mode 100644 index 0000000..ee7ef57 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK Confidentiality and data protection.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Main Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Main Public.PDF new file mode 100644 index 0000000..6de1446 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Main Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Optional.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Optional.PDF new file mode 100644 index 0000000..eff01e0 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF Optional.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF PTE Addendum.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF PTE Addendum.PDF new file mode 100644 index 0000000..4861f4f Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovakia/L1 M25-540 SK ICF PTE Addendum.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/K1_M25-540 SI Recruitment and ICF Procedures.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/K1_M25-540 SI Recruitment and ICF Procedures.PDF new file mode 100644 index 0000000..1678f33 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/K1_M25-540 SI Recruitment and ICF Procedures.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/L1_M25-540 SI Main ICF Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/L1_M25-540 SI Main ICF Public.PDF new file mode 100644 index 0000000..c89ff5f Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Slovenia/L1_M25-540 SI Main ICF Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/K1_M25-540 ES Recruitment and ICF Procedures_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/K1_M25-540 ES Recruitment and ICF Procedures_public.PDF new file mode 100644 index 0000000..1cc8fc2 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/K1_M25-540 ES Recruitment and ICF Procedures_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Main_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Main_public.PDF new file mode 100644 index 0000000..6466e84 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Main_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Optional_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Optional_public.PDF new file mode 100644 index 0000000..cde4213 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Spain/L1_M25-540 ES ICF Optional_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K1 M25-540 SE Recruitment and ICF Procedures_Public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K1 M25-540 SE Recruitment and ICF Procedures_Public.PDF new file mode 100644 index 0000000..0bcc483 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K1 M25-540 SE Recruitment and ICF Procedures_Public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Ad Orebro_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Ad Orebro_public.PDF new file mode 100644 index 0000000..8dc7e57 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Ad Orebro_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Letter Orebro_public.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Letter Orebro_public.PDF new file mode 100644 index 0000000..d9fd9a4 Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/K2 M25-540 SE Recruitment material Letter Orebro_public.PDF differ diff --git a/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/L1 M25-540 SE Main ICF_Public Redacted.PDF b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/L1 M25-540 SE Main ICF_Public Redacted.PDF new file mode 100644 index 0000000..7d7d3fd Binary files /dev/null and b/CTMS/output/Recruitment arrangements and Subject information and informed consent form/Sweden/L1 M25-540 SE Main ICF_Public Redacted.PDF differ diff --git a/CTMS/output/Summary of Product Characteristics (SmPC)/E2_SmPC-vedolizumab.PDF b/CTMS/output/Summary of Product Characteristics (SmPC)/E2_SmPC-vedolizumab.PDF new file mode 100644 index 0000000..d0cee89 Binary files /dev/null and b/CTMS/output/Summary of Product Characteristics (SmPC)/E2_SmPC-vedolizumab.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-CZ.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-CZ.PDF new file mode 100644 index 0000000..36a0f34 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-CZ.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-EN.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-EN.PDF new file mode 100644 index 0000000..1d2aa16 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-EN.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-FR.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-FR.PDF new file mode 100644 index 0000000..c526fd6 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-FR.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-NL.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-NL.PDF new file mode 100644 index 0000000..747ea09 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-NL.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-RO.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-RO.PDF new file mode 100644 index 0000000..94f9477 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-RO.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SE.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SE.PDF new file mode 100644 index 0000000..9c3bddd Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SE.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SK.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SK.PDF new file mode 100644 index 0000000..6716c68 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol lay synopsis-SK.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-DE-AT_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-DE-AT_Public.PDF new file mode 100644 index 0000000..11f8b19 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-DE-AT_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-bulgarian_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-bulgarian_Public.PDF new file mode 100644 index 0000000..ec090a7 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-bulgarian_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-es-spanish_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-es-spanish_Public.PDF new file mode 100644 index 0000000..b454c90 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-es-spanish_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-hu-hungarian_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-hu-hungarian_Public.PDF new file mode 100644 index 0000000..95b6237 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-hu-hungarian_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-it-italian_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-it-italian_Public.PDF new file mode 100644 index 0000000..5e70925 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-it-italian_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-lt-lithuanian_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-lt-lithuanian_Public.PDF new file mode 100644 index 0000000..13b4cb1 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-lt-lithuanian_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-pl-polish_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-pl-polish_Public.PDF new file mode 100644 index 0000000..01cf484 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-pl-polish_Public.PDF differ diff --git a/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-si-slovenian_Public.PDF b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-si-slovenian_Public.PDF new file mode 100644 index 0000000..e83f5f8 Binary files /dev/null and b/CTMS/output/Synopsis of the protocol/D1_m25540-protocol synopsis-si-slovenian_Public.PDF differ diff --git a/IWRS/output/2026-04-27 77242113UCO3001 CZ IWRS overview.xlsx b/IWRS/output/2026-04-27 77242113UCO3001 CZ IWRS overview.xlsx new file mode 100644 index 0000000..91f0461 Binary files /dev/null and b/IWRS/output/2026-04-27 77242113UCO3001 CZ IWRS overview.xlsx differ diff --git a/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100843.xlsx b/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100843.xlsx new file mode 100644 index 0000000..e22b0a6 Binary files /dev/null and b/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100843.xlsx differ diff --git a/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100845.xlsx b/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100845.xlsx new file mode 100644 index 0000000..737032a Binary files /dev/null and b/IWRS/xls_shipment_details_77242113UCO3001/shipment_details_100845.xlsx differ