Check out the publication of a new EMA document of frequently asked questions (FAQ) for sponsors on the Clinical Trials Information System (CTIS): https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis-training-support#frequently-asked-questions-for-clinical-trial-sponsors-84652
The FAQ is based on questions raised by sponsors to the EMA during CTIS events and via the CTIS Service Desk . It complements the CTIS Sponsor Handbook and provides additional guidance on specific topics, including:
- IMPD-Q only applications
- content requirements for clinical study reports (CSRs) to be submitted in CTIS
The FAQ was delivered under the ACT EU priority action supporting implementation of the Clinical Trials Regulation, as part of the effort to redesign the CTIS training material. A focus group of members identified through the MSP advisory group contributed to the finalisation of the FAQ document.