The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often foresee the challenge of RFIs as being a worrisome topic.
Our experience has shown that indeed, for CTAs submitted under the EU CTR, the coordinated assessment of Part I can lead to a cumulated hundred of RFIs. Nonetheless, RFIs shall be addressed within a maximum of 12 calendar days, in parallel of which participating member states may raise Part II RFIs.
From both operational and organizational perspectives, this critical period requires anticipation and a thorough preparation, especially considering that most of the time, important core documents (protocol, IB, IMPD, etc.) have to be updated to satisfyingly address the RFIs.
Our experts have practical experience of Response to RFIs gained over the past year and will attempt to answer your questions on this topic. We will also share some practical tips and advice on how to best prepare for making this process as smooth as possible, including the following parts:
- What is an RFI?
- What types of Request for Information are there?
- What can CTA-RFIs cover?
- When can RFIs be raised during the CTA Review?
- How much time do sponsors have to respond to a CTA RFI?
- What are the consequences of not responding to CTA RFIs?