Transparency, transition period addressed in new EMA Q&A guidance on CTR implementation
The European Medicines Agency (EMA) has issued a guidance in a question-and-answer format to assist sponsors in navigating the Clinical Trials Regulation (CTR) and the new clinical trials information system (CTIS) portal. Use of the CTIS became mandatory on 31 January.The Q&A was developed by EMA’s Query Management Working Group (QMWG) to clarify some areas of ambiguity raised by stakeholders, which included the Association of Clinical Research Organizations (ACRO), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Clinical Research Organization Federation (EUCROF).
The guide also includes a list of references and a table listing the referenced documents in the Q&A with their online address.
The guide complements an earlier version on the rules and procedures of the CTR alongside questions and answers on protecting commercially confidential information when using CTIS. (RELATED: Euro Roundup: EMA shares guidance on CTR, confidential data a new rules take effect, Regulatory Focus 2 February 2023)
The guide is broken into 11 areas, with the topic of transparency generating the most questions (19), followed by the Clinical Trial Application (CTA) document (18) and training and support (12).
Other topics include CTIS implementation, the General Data Protection Regulation (GDPR), master data sources, submitting the CTIS in non-EEA countries, safety, training and support, user management and the transition period.
In the transparency area, one question addressed whether there is any opportunity to amend redacted documents after CTA approval and before the document is disclosed to the public.
The answer: “Structured data and documents submitted via CTIS are publicly available according to the publication rules. The content of the documents provided in a CTA can only be modified during the application evaluation phase, by raising an RFI [Request for Supplementary Information]. After a decision is issued by the MSC [Member State Concerned] on the application, it will no longer be possible for the sponsor to modify that application, even if the documents are not published yet due to deferral rules.”
Another question in this area concerned the possibility of getting information removed if placed in the public domain by mistake. The answer: “The removal of the document can be requested via the Request removal of public information link on the CTIS public website. The EMA removes the document if the request is valid. Documents cannot be removed from the public domain by sponsors or authorities, this function is only available to the EMA users.”
For the CTA, questions addressed whether the protocol synopsis in the application needs to be provided in lay language as a separate attachment to the protocol.
The answer: “According to the EudraLex – Volume 10 Q&A, the synopsis can be part of the protocol or submitted as a separate document, especially to address different language versions. The content of the synopsis is proposed in the Q&A and it is stated that sponsors should consider making the synopsis understandable to a layperson.”
Experts previously told Focus that transparency issues, including the requirement to submit two sets of documents in the portal, a set of proprietary documents that cannot be released publicly and a set of non-proprietary information that can be published, are an ongoing challenge in implementing CTIS. (RELATED: Experts offer CTIS advice on eve of transition for new applications, Regulatory Focus 30 January 2023)
EMA
