Reactive and Proactive Strategies for Expedited Protocol Amendments under EU-CTR – EDG

The European Union Clinical Trials Regulation (EU-CTR), EU No. 536/2014, has replaced the EU Clinical Trials Directive (EU‑CTD), EC No. 2001/20/EC, for clinical trial applications in the EU. Under the new regulation, after submitting a trial dossier to the European Medicines Agency (EMA), sponsors receive Requests for Information (RFIs) following dossier assessment by EMA member states. Typically, the RFI response period is only 12 calendar days (approximately 8 working days). This timeline is challenging as the RFI response may include a protocol modification (amendment) and updates to associated documents (Lay Protocol Summary and redacted protocol version), as well as translations. This Expert Discussion Group will draw on the participants’ experiences in and strategies for RFI-related protocol modifications.

The focus will be on:

1. Reactive strategies for addressing RFIs in protocol amendments:
   1. Achieving team consensus on the RFI response
   2. Strategy for expediting protocol amendment development
2. Proactive strategies for mitigating risks of RFIs on the protocol:
   1. Team preparation and a planned expedited process for CSP modification
   2. Updates to protocol template based on experience with RFIs

Addressing these demands requires extensive cross-functional collaboration between all stakeholders. The aim of the group discussion is to propose best practices for managing protocol modification. By sharing experiences and insights, this Expert Discussion Group will seek to provide practical solutions for navigating the complexities of the EU-CTR and its impact on protocol development and management.

Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators, and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.