14 KiB
14 KiB
| 1 | Protocol | Country | Site | PI Name | Subject ID | Age at Informed Consent | Baseline Stool Count | Confirm Baseline Stool Count | Data Correction ID | Creation Date UTC | Status | Description | Date of Last Action UTC | Total Open Period | Total Open Time (Days) | Current Status Time (Days) | Type | Next Action Required | Category | Query History | Reason for Change | Resolution |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 | 77242113UCO3001 | Czech Republic | DD5-CZ10001 | Matej Falc | CZ100012001 | 48 | 1 | SW00703544 | 13-May-2026 | Submitted | Please change answer to clinical remision from no to YES (week 12). Entry erros | 20-May-2026 | 22-28 Days | 25 | 20 | Query Active | Site | New | (1) 20 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification Request. For us to process your request, please let us know the name of the form (with date) with question. Thank you. ERT/CLARIO Data Coordination Team | Entry Error | ||
| 3 | 77242113UCO3001 | Czech Republic | DD5-CZ10001 | Matej Falc | CZ100012002 | 79 | 1 | SW00696586 | 09-Apr-2026 | ReadyForQC | Please correct date of endoscopy to date: 18 March 2026 (from 25 March 2026) | 15-Apr-2026 | Over 28 Days | 47 | 44 | Query Active | Site | Site-Entered Data | Entry Error | CLARIO RESOLUTION: Part 1: In Mayo Subscore (1) dated 08 Apr 2026 for I-0 visit, CLARIO to make the following changes: - What was the date of endoscopy? (ENDODT1D): from 25 Mar 2026 to 18 Mar 2026 - Data Flag (QSDFLG1B): from blank to check | ||
| 4 | 77242113UCO3001 | Czech Republic | DD5-CZ10006 | Michal Konecny | CZ100062001 | 19 | 1 | SW00704536 | 19-May-2026 | ReadyForQC | Please change the endoscopy date to 19-FEB-2026. 06-MAR-2026 was entered in error. | 26-May-2026 | 15-21 Days | 21 | 16 | Query Active | Site | Site-Entered Data | Entry Error | CLARIO RESOLUTION: Part 1: In Mayo Subscore (1) dated 20 Mar 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 06 Mar 2026 to 19 Feb 2026 - Data Flag (QSDFLG1B): from blank to check | ||
| 5 | 77242113UCO3001 | Czech Republic | DD5-CZ10012 | Stefan Konecny | CZ100122001 | 22 | 5 | Yes, I confirm this is the correct stool count. | SW00706684 | 01-Jun-2026 | Submitted | The right endoscopy date is 23MAR2026, please change the date | 15-Jun-2026 | 8-14 Days | 13 | 4 | Clario DM | New | (1) 05 Jun 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please confirm that if you are requesting following. Mayo Subscore (1) dated 07 Apr 2026 for I-0 What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 23 Mar 2026 Thank you. ERT/CLARIO Data Coordination Team. (2) 15 Jun 2026 hosova.kristyna@fnbrno.cz (Site User): The endoscopy was performed 23MAR2026 | Entry Error | ||
| 6 | 77242113UCO3001 | Czech Republic | DD5-CZ10013 | David Stepek | CZ100132002 | 29 | 1 | SW00705646 | 26-May-2026 | ReadyForQC | Correct visit date I-O is 12-May-2026. All questionaries were filled on paper and entered in tablet later. Log-in issue. | 15-Jun-2026 | 15-21 Days | 17 | 4 | Clario DM | Visit Data | (1) 01 Jun 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please provide the timestamps for each of the assessments if you used paper forms and transcribed into the device. If unknown, ERT will use a dummy timestamp. Thank you. ERT/CLARIO Data Coordination Team. (2) 01 Jun 2026 dstepek@vnbrno.cz (Site User): time is unknown | Changed Information | CLARIO RESOLUTION: Part 1: In the following forms for I-0, CLARIO to make the following changes: -Report Date: from 26May 2026 to 12 May 2026 -Report Start Date and time: from 26 May 2026 to 12 May 2026 23:59:59 -Event End Date: from 26 May 2026 08:27:57 to 12 May 2026 23:59:59 +Tablet Training Module (1) +Participant Start Instructions (1) +IBDQ (1) +PROMIS Fatigue – Short Form 7a (1) +BASDAI (1) +Participant End Instructions (1) +Visit End (122) | ||
| 7 | 77242113UCO3001 | Czech Republic | DD5-CZ10013 | David Stepek | CZ100132003 | 49 | 1 | SW00708623 | 10-Jun-2026 | Cancelled | Correct date of I-2 is 26.5.2026. all questionaries were entered on paper at 07,45 and transmited later. | 10-Jun-2026 | 1 Day | 1 | New | yes, subject mishmasch | ||||||
| 8 | 77242113UCO3001 | Czech Republic | DD5-CZ10013 | David Stepek | CZ100132003 | 49 | 1 | SW00706581 | 29-May-2026 | Completed | baseline stool count reported by subject is 0, please change to 1 as per CRA request (subject has 1 stool in 2-3 days if in remission) | 10-Jun-2026 | 4-7 Days | 7 | Demographic | Changed Information | CLARIO RESOLUTION: Part 1: In System Variables form, CLARIO to make the following changes: - Baseline Stool Count (PT.Custom4): from 0 to 1 | |||||
| 9 | 77242113UCO3001 | Czech Republic | DD5-CZ10016 | Robert Mudr | CZ100162001 | 48 | 1 | SW00705916 | 27-May-2026 | Completed | As per ATS investigation (ATS26040111), please remove the below form which was entered as a duplicate - MAYO Diary (5) 24 Apr 2026 | 10-Jun-2026 | 8-14 Days | 9 | Technical Revision | Technical Revision - Other | CLARIO RESOLUTION: Part 1: CLARIO to delete MAYO Diary (5) dated 24 Apr 2026 | |||||
| 10 | 77242113UCO3001 | Czech Republic | DD5-CZ10020 | Lucie Gonsorcikova | CZ100201001 | 15 | 1 | SW00701729 | 06-May-2026 | Completed | Dears, please delete data from visit I-0 (reported as 4th of May 2026) as this visit had to be postponed - see the previous DCR of this patient and change data request that was corrected. Patient has left the site before it was resolved and and new date of I-0 was planned. Patient continues to fill in his diary and patient is coming to I=0 visit within allowed window. We need the system and tablet to be ready to run new Mayo Score Report with updated and recent data (e.g. reflect new I-0 visit date, new eligible days -1 to -7.). thank you, Jiri Skopek | 19-May-2026 | 8-14 Days | 8 | Visit Data | (1) 11 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please note that the delete forms are allowed if the reason is one of the following. If not, forms will move to unscheduled visit. Data collected by the wrong patient. Data collected by someone other than the patient. Data collected prior to informed consent, or after withdrawal from the study. Duplicate data erroneously entered at an Unscheduled visit via paper transcription. Data collected that is not expected per protocol. Also, I-0 visit is still ongoing. Please close the visit. Once the visit was closed, we will process accoridngly. Thank you. ERT/CLARIO Data Coordination Team (2) 11 May 2026 jskopek (Site User): Dears, I do not see any option that is adequate -from the list. Data are not needed to be deleted fully, they reflect the situation at May4th. Please mark it as unscheduled visit - as exactly that is the case. We need the system to be ready for I-0 visit planned for next week. I will close the visit tomorrow - do you mean in tablet/ipad? Thank you very much for your help! Jiri (3) 12 May 2026 venkata.ramana (Clario): Thank you for your response. Please note that the visit I-0 was still ongoing but not closed yet. So please close the visit. Kind Regards, Clario Data Coordination Team. (4) 12 May 2026 jskopek (Site User): If I try to close the I-O visit in TABLET, it asks me if patient fulfils eligibility criteria to proceed to next visit based on these old data – if I answer NO, it asks me to DEACTIVATE patient. I do not want to DEACTIVATE patient – can you help WHERE and HOW to close this visit for you to change it to UNSCHEDULED and not to de-activate patient? Thank you Jiri | Other-delete visit I-0 | CLARIO RESOLUTION: Part 1: In the following forms dated 04 May 2026, CLARIO to make the following changes: -Event ID: from I-0 to Unscheduled Visit 1 -Event At Entry: from I-0 to Unscheduled Visit 1 +Visit Start (49) +ePRO Availability (1) +Mayo Subscore (1) +PGA (1) Part 2: CLARIO to delete the following forms dated 04 May 2026 for I-0 visit. +C-SSRS Since Last Visit (1) +C-SSRS Since Last Visit Findings Report (1) Part 3: CLARIO to manually enter Visit End form for Unscheduled visit 1 with the following information: -Protocol: 77242113UCO3001 -Report Date: 04 May 2026 -Report Start Date and Time: 04 May 2026 23:59:59 -Event ID: Unscheduled Visit 1 -Event End Date: 04 May 2026 23:59:59 -Visit Status: Incomplete -Phase At Entry: Screening -Phase At Entry Timestamp: 13 Apr 2026 12:32:20 -Event At Entry: Unscheduled visit 1 -Event Start Date: 04 May 2026 23:59:59 -Event Time Zone Offset in Milliseconds: 7200000 -Session Repeat Number (SESREP1N): 0 -Session Instance Id (SESINST1S): 3f1214f0-4788-11f1-a0cf-bb403212adce | ||||
| 11 | 77242113UCO3001 | Czech Republic | DD5-CZ10020 | Lucie Gonsorcikova | CZ100201001 | 15 | 1 | SW00701226 | 04-May-2026 | Completed | Dears, we would like ask you to change the information I read on assignment form given by patient on April 13, 2026 (Visit 1), Baseline Stool Count (PT.Custom4) as 3 that should be reported as 1. Patient has entered wrong number as he did not understood it should be number of stools when illness is in remission or absent. He is a child and did not reflected this question correctly. Therefore, please change Baseline Stool Count = 1. Thank you, Jiri Skopek | 04-May-2026 | 1 Day | 1 | Demographic | Changed Information | (Clario instructions) 1. Please make below changes in the assignment form: Baseline Stool Count (PT. Custom4): 03 to 01. | |||||
| 12 | 77242113UCO3001 | Czech Republic | DD5-CZ10021 | Martin Bortlik | CZ100212001 | 61 | 1 | SW00699492 | 23-Apr-2026 | ReadyForQC | Please correct the date of endoscopy done during screening visit of patient CZ100212001 to correct date 16-MAR-2026. | 29-Apr-2026 | Over 28 Days | 38 | 34 | Query Active | Site | Site-Entered Data | Changed Information | CLARIO RESOLUTION: Part 1: In the Mayo Subscore (1) dated 07 Apr 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 16 Mar 2026 - Data Flag (QSDFLG1B): from blank to check | ||
| 13 | 77242113UCO3001 | Czech Republic | DD5-CZ10022 | Petr Hrabak | CZ100222003 | 39 | 1 | SW00703322 | 12-May-2026 | Completed | As per ATS investigation (ATS26040111), please remove the below form that's been entered as a duplicate - MAYO Diary (16) - 18 Mar 2026 | 20-May-2026 | 4-7 Days | 6 | Technical Revision | Technical Revision - Other | CLARIO RESOLUTION: Part 1: CLARIO to delete the MAYO Diary (16) dated 18 Mar 2026. | |||||
| 14 | 77242113UCO3001 | Czech Republic | DD5-CZ10022 | Petr Hrabak | CZ100222003 | 39 | 1 | SW00689748 | 09-Mar-2026 | Completed | Dear all, Patient CZ 100222003 was randomized on 9 Mar 2026. Kindly correct the colonoscopy date to 11 Feb 2025. The date was initially entered as 21 Feb 2025 because the earlier date could not be entered in the system. The patient was rescreened. | 02-Apr-2026 | 15-21 Days | 17 | Site-Entered Data | (1) 13 Mar 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Could you please conform that if you are requesting following? Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit -What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025 Could you please confirm the year? This subject was assigned on 02 Mar 2026, you are providing that correct date is 11 Feb 2025 which a year ago. If you are not requesting above, please provide us the name of the form with question. Thank you. ERT/CLARIO Data Coordination Team (2) 13 Mar 2026 katerina.havlikova@clinoxus.com (Site User): confirm date of colonoscopy 11Feb2026 (3) 21 Mar 2026 msullivan (Clario): Dear Site, The requested changes to the Mayo data have been updated. Please navigate to the Mayo Score Report and resubmit the form for visit to log the updated Mayo Score form. Once done, please respond to this query confirming that the Mayo Score has been resubmitted. Thank you. ERT/CLARIO Data Coordination Team (4) 24 Mar 2026 jana.pomahacova@clinoxus.com (Site User): Thank you and sent | New Information | CLARIO RESOLUTION: Part 1: In the Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025 -Data Flag (QSDFLG1B): from blank to check | ||||
| 15 | 77242113UCO3001 | Czech Republic | DD5-CZ10022 | Petr Hrabak | CZ100222005 | 33 | 1 | SW00705372 | 22-May-2026 | Submitted | Dear all, please change Colonoscopz date from 8April2026 to date 01Apr2026 Thank you in advance | 12-Jun-2026 | 15-21 Days | 18 | 4 | Query Active | Site | New | (1) 29 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please provide us the name of the form for this request. Thank you. ERT/CLARIO Data Coordination Team (2) 02 Jun 2026 katerina.havlikova@clinoxus.com (Site User): Dear all, please change Colonoscopy for Week I-12 date from 8April2026 to date 01Apr2026 Thank you in advance (3) 12 Jun 2026 msullivan (Clario): Dear Site, Please note that there is no I-12 visit in StudyWorks. If you completed visit and stored, please submit all stored reports. Until we see the data in StudyWorks, we are unable to confirm your request. Also, please provide us the name of the form for this request. Thank you. ERT/CLARIO Data Coordination Team | Changed Information | ||
| 16 | 77242113UCO3001 | Czech Republic | DD5-CZ10022 | Petr Hrabak | CZ100222005 | 33 | 1 | SW00702538 | 08-May-2026 | Completed | This TRR is to document the correction to the Mayo Subscore (1) form, where the following variables were populated with NULL values, due to a known core defect: Event At Entry, Event Start Date, Event Time Zone Offset in Milliseconds. | 12-May-2026 | 2-3 Days | 2 | Technical Revision | Technical Revision - Other | Please make the below changes in Mayo Subscore (1) dated 22 Apr 2026: -Event At Entry: I-0 -Event Start Date: 09 Apr 2026 08:09:19 -Event Time Zone Offset in Milliseconds: 7200000 |