Q&A on the protection of CCI & PPD while using CTIS released today
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
As previously mentioned, the?"Q&A on the protection of commercially confidential information and personal data while using CTIS" that was planned to be released was published today by the EU Commission, EMA & HMA (CTCG).
The 8-page document have 3 chapters with the following number of Questions:
?The Q&A document has been produced to address a number of questions related to the transparency aspects of CTIS which were communicated by sponsors in response to the ACT EU survey on the CTR implementation under ACT EU Priority action 2 (Successful implementation of the CTR).
It is foreseen that the Q&A may be updated on a regular basis as soon as new information becomes available.?
The same principles described in this Q&A will be incorporated in the "Guidance document on how to approach the protection of personal data (PD) and commercially confidential information (CCI) in documents uploaded and published in the Clinical Trial Information System (CTIS) (EMA/212507/2021)" ? once finalised (1Q23 probably).?
Thank you Pierre for sharing
Clinical Operations Consultant | Founder & Managing Director Oriel Research Services | GCP | Regulations | Quality by Design (QbD) | Gap Analyses | Risk Assessment | Vendor Oversight | Research Ethics |Training
2 年Thank you for sharing, Pierre. Where is it posted? I have checked Eudralex Volume 10 and don't see it.