EudraCt Results Webinar #1 Presented by Tim Buxton

In this webinar, Tim Buxton discusses EudraCt trial results submission deadlines, system operations, and activities required for normal operation post-trial. The webinar addresses sponsor responsibilities, data correction, EMA authorizations, and affected trial results sets. It also covers timelines, key dates, and guidelines for compliance with the EudraCt system.

• EudraCt
• Results
• Webinar
• Tim Buxton
• Trial

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1. EudraCt Results Webinar # 1 Presented by Tim Buxton on 20 January 2016 An agency of the European Union IT Service Strategy Manager, IT Operations

2. Instructions for sponsors Frequently asked questions 1

3. Timeline 21 21 Deadline for submission of Deadline for submission of December December summary results for trials summary results for trials 2016 2016 categorised as to be posted 24 categorised as to be posted 24 13 January 13 January Date from which EudraCT Date from which EudraCT - - months after finalisation of the months after finalisation of the 2016 2016 Results system is available Results system is available programming (see document programming (see document Trial Trial Posting and publication process Posting and publication process results: modalities and timing of results: modalities and timing of operational operational posting posting published on the EudraCT published on the EudraCT website) website) 13 March 13 March Results sets falling due after this Results sets falling due after this 2016 2016 date (except those for trials date (except those for trials categorised as to be posted 24 categorised as to be posted 24 months after finalisation of the months after finalisation of the programming) should comply with programming) should comply with the modalities and timing of trial the modalities and timing of trial results results 13 July 13 July Date by which results sets affected Date by which results sets affected 2016 2016 by the system closure are to have by the system closure are to have been posted. been posted. Q1 Q2 Q3 Q4 2

4. Activities necessary to return to normal operation Review by sponsors of trial results sets within the system leading to: Correction where needed by the sponsor Authorisation to EMA to restore results sets to public view where no correction is needed Submission of data Affected results sets Results for trials categorised as to be posted 24 months after finalisation of the programming 3

5. Affected results sets Results sets that were posted, published and removed from public view as of 31 July 2015 Results sets that had been posted but not yet published as of 31 July 2015 Results sets that fell due in the period that the system was closed (31 July 2015 to 12 January 2016) Results sets that fall due in the two months following re- opening of the system (13 January 2016 to 13 March 2016) 4

6. Resources: Schedule of trials assigned to a primary user Potential timestamp issues Yes No No Yes No Yes Yes Potential category issues No Yes No Yes No Yes No Data correction applied No No Yes Yes No No Yes User Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Ronald.Held@FictitiousPharma.com a1a1a1 Name EudraCT No. 2013-001234-39 2015-001234-27 2015-001235-28 2011-001234-26 2012-001234-70 2010-000123-68 2011-000012-13 Published Public Public Public Public Not public Not public Not public State FINALIZED FINALIZED FINALIZED FINALIZED FINALIZED DRAFT DRAFT 5

7. Resources: Release notes for version 10.2.1.0 Summary of release 10.2.1.0 Major items fixed in release 10.2.1.0 Known issue in release 10.2.1.0 Full release contents Issues fixed Known errors New Validation Violation Messages (for XML upload) in EudraCT - Results 10.2.1.0 Additional information Installation steps deviating from the deployment guide 6

8. Trials potentially affected by timestamp issues 7

9. Trials potentially affected by category issues 8

10. Trials where an automated process has been run to eliminate duplicated non-completion or joining reasons User Ronald.Held@FictitiousPharma.com2013-001234-39 Ronald.Held@FictitiousPharma.com2015-001234-27 Ronald.Held@FictitiousPharma.com2015-001235-28 EudraCT Number Period Title Arm Title Phase 2 Arm C - 40 mg Fictilion Phase 2 Arm A - 20 mg Fictilion Reason ID 1 Reason ID 2 No. of Subjects 15982 15982 22756 Phase 1 and Phase 2 Phase 1 and Phase 2 8 5 2 Type or text Adverse event Adverse event 106, Consent withdrawn by subject Subject disposition ID Period Reason category 5571 Post-Assignment Not completed reason having type "Other" with same other reason text 5571 Post-Assignment Not completed reason having type "Other" with same other reason text 11872 Pre-Assignment Not completed Reason whose type is not "Other" (but from the specified list in R_TERMS table) 9

11. Restore status and return to public view process Notifications Sponsor notification to EMA: Finalized results set in the system is correct EMA notification to sponsor: Status of finalized results set is restored Published messages: Messages removed: Removed from public view These results have been removed from public view whilst they are reviewed and may need to be corrected before being returned to public view 10

12. Tagging of superseded versions of results sets that included affected data Notifications Sponsor notification to EMA: New version of finalized results set containing corrected data EMA notification to sponsor: Superseded versions tagged Published messages Messages removed: Removed from public view These results have been removed from public view whilst they are reviewed and may need to be corrected before being returned to public view New message: Due to a system error, the data reported in this version is not correct and has been removed from public view 11

13. Tagging of results sets submitted in compliance with revised timelines Notifications Sponsor notification to EMA: Results set submitted in compliance with revised timelines EMA notification to sponsor: Results set submitted in compliance with revised timelines tagged Published message New message: Due to the EudraCT Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines 12

14. Instructions for sponsors Frequently asked questions 13

15. EudraCt Training Training environment System and data availability [EMA] does not guarantee the availability of the training application. The system may be refreshed from time to time and this may cause the loss of data saved into the application as well as loss of user log in credentials. Any trials data prepared in the EudraCT training environment are for training purposes only. Status Most credentials still valid Previously available data no longer available Self-registration and trial assignment available 14

16. Draft trials - message All trials in the system as of 31 July 2015 which had been assigned for results tagged with the message: These results have been removed from public view whilst they are reviewed and may need to be corrected before being returned to public view Not appropriate for trial results that had not been posted as of 31 July 2015 Removed from all draft trial results to which attached as of 31 July 2015 15

17. Primary user EMA assigns each clinical trial to a primary user for result related information On request of an individual acting on behalf of the sponsor, the addressee of the decision on a paediatric investigation plan or the marketing authorisation holder This assignment enables the user to assign one backup user and multiple delegated results preparers and posters for each listed trial The primary user is expected to manage the backup user and delegated preparers, and the transition between primary users on change of personnel or assignment at the sponsor 16

18. Issue resolution The release notes list the issues resolved in release 10.2.1.0 A number of service desk tickets remain open. These will be closed gradually as part of the return to normal operation 17

19. Outcome of the automated duplicate reason fix 1. Is it possible to download XML from a finalised Results set? Yes. XML of the current version, including finalized results, can be downloaded at any time 2. Are records affected by the automated duplicate reason fix tagged? No. A detailed listing has been supplied to all primary users whose trial results sets have been subject to the automated duplicate reasons fix 3. Is there a norm for this category? All trial results sets in which the duplicate reason was identified have been corrected, and the status (whether draft or finalized) left unchanged 18

20. Communications For the formal notifications outlined in the Instructions for sponsors; and The acknowledgement of the email with the Instructions for sponsors; Use: EudraCT-R@ema.europa.eu For all other queries related to EudraCT Results and this exercise, please use: eudract@ema.europa.eu 19