Since the launch of CTIS in 2022, the deferral functionalities have proven to be complex from an information management and data security perspective, which has led to some uncertainties in the use of CTIS when deferrals were applied. The deferral functionality, foreseen in the ‘Appendix on disclosure rules’ and implemented at the time of the launch of the system, will continue to remain in place until a new CTIS public website, implemented in line with the revised CTIS transparency rules, is available.

The CTIS transparency rules implemented at the time of the launch of CTIS, with extensive publication of data and documents, published even if provided as optional attachments to information already captured in the structured data field, and not focussed and tailored to the documents of interest for patients and clinical researchers, mixed with complex system functionalities, has had an impact on the use of the system.

The derogations for the disclosure of documents in paragraphs (c) and (d) of Article 81(4) of the CTR allows Member States competent authorities to protect confidential communication between Member States in relation to the preparation of the assessment report or to ensure effective supervision. These derogations have been in use since system launch and as a result draft assessment reports are not published, nor is information on planning of supervision activities (i.e. GCP inspections).

For certain other documents currently published via CTIS, redaction is applied to protect CCI, in line with the provisions of Article 81(4)(b). It should be noted that extensively redacted documents, in their published version, are of limited utility to stakeholders, including patients.


Revised CTIS Transparency Rules