European Medicines Agency's (EMA's) Clinical Trial Regulation (CTR) & Clinical Trial Information System (CTIS): Trial Sponsor and CRO Frequently Asked Questions

Are Member States reviewing public version documents in CTIS and could my ‘for publication’ document redactions result in an RFI?

The guidance from EMA has been consistent: if you are deferring, ‘for publication’ version documents should contain minimal if any redactions upon upload to CTIS. Further, the guidance states that Sponsors should not defer and redact.

At the start of the CTIS launch in 2022 it became clear that Member States were not reviewing ‘for publication’ documents to ensure conformance to this expectation - although it was expected that study sponsors adhere to the guidance at all times. However, more recently, multiple study sponsors have begun to receive RFIs as a result of heavy redaction in ‘for publication’ documents. It is important for all study sponsors to remember that when deferring, only commercially sensitive information at the time of publication (following the deferral period, if applicable) should be redacted. EMA is expecting all ‘for publication’ documents to be meaningful for the public.

Link to Sponsor Handbook with guidance regarding deferral and ‘for publication’ document redaction.
Link to EMA
CTR Questions & Answers Version 6.5, see Question 6.5, paragraphs 259-261.

My organization considers the dosing information for my CTIS project as Confidential (CCI). However, CTIS requires metadata fields be populated with dosing information. How can a Sponsor approach the protection of this information?

Depending on the phase of the trial, Sponsors can protect this information from becoming public despite certain CTIS fields requiring an input. Below is EMA’s guidance from section 3.3 “Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS”:

How can dose details be protected from disclosure from CTIS for certain trials category falling within category 2?
The main characteristics of medicinal products used in clinical trials falling under category 2 are subject to publication rules after a decision on the clinical trial application is issued by the first Member State concerned.

These main characteristics also include structured data fields on daily dose allowed and maximum dose allowed for the medicinal product under investigation. In some instances, depending on the trial development phase, dose details may be considered to be CCI. In such instances, sponsors can include ‘dummy data’ (e.g. 00 digits) in the related structured data field(s) of CTIS.

The full information on the posology should, however, be provided to the Member States for assessment in the document version ‘not for publication’ and can be redacted in the corresponding documents to be published.

This approach would be acceptable only on justified grounds, i.e. when the sponsor proves that the specific information on the posology is not in the public domain and constitutes patentable matter, the disclosure of which before a patent application is filed (typically, after the completion of the trial and during the trial readout) would jeopardize its protection.

This might be applicable for example to integrated phase I/phase II trials that are to be marked in CTIS as category 2 trials. The grounds for considering dose details as CCI should be clearly documented in the cover letter of the application. Link to additional Guidance


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