Publication of clinical trial documents during the transition period

New transparency rules can already be used for clinical trial documents, although the portal will only be updated later. Changes to be made to the public section of the EU portal for clinical trials were published in October (EMA). The changes include that there will no longer be any delay in publication and the publication of information and documents will depend on the category of the study.  New changes to clinical trial data will take effect once the portal is complete. 

Sponsors can already comply with the new transparency rules in their new research applications in the case of documents that would have been public under the previous transparency rules but are confidential under the amended transparency rules. This is done by uploading an explanatory document to the CTIS’s section for public documents, e.g. a question-answer guide for publishing of information in the portal With the text proposed in Annex 1: ”The present document is no longer subject to publication in line with revised CTIS transparency rules. Further information is provided in section 4 of the ‘Q&A (pdf) on the protection of Commercially Confidential Information and Personal Data while using CTIS’ published on the ACT EU website – Implementation of the Clinical Trials Regulation.”). The correct document is then uploaded to the section ”Not for publication”. In this case, no delay should be requested for the publication of the information. 

The authorities use this same approach for final assessment reports and decisions. Documents of studies that were previously uploaded to the CTIS portal will not be published, no matter what the time of delay selected for them was. After this provision, for example, in the case of significant changes, the sponsor must take into account the redaction of personal data and business secrets, as the protocol and synopsis will be documents made public in accordance with the new rules. 

The research plan, patient information and consent form will become public from the studies to be transitioned, i.e. the studies that will be transferred from falling under the Directive to falling under the scope of the Regulation.  

Read more:

Revised CTIS Transparency Rules (pdf)

Brief instructions for sponsors (pdf)

Updated question-answer document related to the above. The new fourth paragraph in the document deals with e.g. the transition period (pdf)