EU CTIS Disclosure rules and Transparency measures are under review
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
According to the highlights of the EMA Management Board (14-15Dec22), "The Board also agreed to review the current rules on disclosure of certain?clinical trial?documents and a review of CTIS transparency measures for 2023".
At the "Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023" webinar yesterday (20Jan23)
We also heard that:
* A new Q&As on Protection of CCI & PPD in CTIS is expected to be published within days from HMA Clinical Trials Coordination Group (CTCG);
* The "Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” (published in 2015) will probably be reviewed (and possibly be clarified);
* The Transparency Rules are reviewed this quarter from the CTIS Delivery plan 2023;
There is clearly an ongoing broad review of these topics.
The key missing information is the planned date for the full restart of the CTIS Public Web site (a hundred clinical trials are currently public out of the +200 already with a decision). This will happen after all the above have been completed probably.
Stay Tuned.
https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2022-meeting