The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR).
The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
Questions and answers on special trial designs
The following topics are covered by the questions and answers on special trial designs:
- Follow-up of patients after a clinical trial has ended
- Novel-novel clinical trials
- Integrated protocols (trial containing two parts)
Questions and answers on special trial designs: CTFG: Questions and Answers by the CTFG on clinical trials. Answers to frequently asked questions
Questions and answers on DSUR (Development Safety Update Report)
Once a year throughout the duration of the clinical trial, the sponsor must provide a list of all suspected serious adverse reactions which have occurred during the trial period and a report on the trial subjects’ safety.
The list and the report must be submitted to the competent authorities in the Member States on whose territory the clinical trial is carried out.
In future, the annual report and list of serious suspected adverse reactions can be replaced by the Development Safety Update Report (DSUR, ICH E2F).
Questions and answers on DSUR: CTFG: Questions and Answers to the Annual Safety Report. Frequently asked questions regarding the Development Safety Update Report (DSUR)
More information about DSUR: ICH: Efficacy Guidelines.