Sponsors now have some details of the expectations for posting CSRs on CTIS. Some CSRs are coming due for early adopters. It's great to have this clarity coming from the EMA.
The #CTD2024 DIA event discussion with regulators provided some key updates on EU CTR. Here are a few key highlights:
✅ The scope for CSRs under CTIS is clear now, it is the same as Policy 0070. This includes CSR sections 1 through 15 and appendixes 16.1.1, 16.1.2, and 16.1.9. Module 2 is not in scope for CTIS publication.
❇️ CSRs are going to be due for upload on CTIS before Policy 0070 based on regulatory timelines. There was a lot of discussion around how this will be challenging for sponsors.
✅ CSRs are not expected to be reviewed on CTIS.
❇️ There are more CSRs in scope for publication on CTIS then EMA Policy 0070. Remember Policy 0070 only covers central procedures whereas CTIS includes any submission to any EUA countries individually.
✅ There was a brief discussion around posting technical results on CTIS. It was suggested that for now, the EUDRACT form could be used to upload results to CTIS.
❇️ A final note worth a heads up is that if you transition a study as part of a substantial modification to a new sponsor, updating the org ID number triggers the system to publish documents.
Brief note on Policy 0070:
✳️ EMA expects to provide an update on plans for part 2 restart for packages that have been on hold sometime in 2025.
✳️ Phase 2 implementation details are not currently under any discussion within the EMA.
#CTD #CTT #ClinicalTrialTransparency #EUCTR #CTIS #CSRs #Policy0070
