The European Commission (EC) has issued an updated Q&A outlining what information sponsors should provide in the protocol synopses they must submit with their clinical trial applications under the upcoming Clinical Trials Regulation (CTR) set for launch in January 2022.

The synopsis, which should be two pages long at most, should be understandable to the average person and can be included within the protocol itself or attached as a separate document if it’s submitted in different languages.

The Q&A explains that the EC expects a synopsis to include:

• The EU trial number and full title of the trial;
• Rationale (the background and hypothesis of the trial);
• Objective (the main and secondary objectives of the trial);
• Main and secondary trial endpoints (a description of the primary and secondary trial endpoints and when they are assessed);
• Trial design (the design and expected duration of the trial for individual subjects);
• Trial population (a description of the trial population that indicates the main inclusion criteria being used, as well as the exclusion criteria in place to protect subjects);
• Interventions (a description of the interventions and treatment duration, as well as background treatment, if applicable); and
• Ethical considerations for the trial (including expected benefit, burdens and risks to trial participants).

It also includes a new Q&A section clarifying how sponsors should report their anticipated submission date for annual safety reports (ASRs).

Further updates of the Q&A, which is still in draft form, will be issued, the commission noted.

Read the full revised Q&A here: https://bit.ly/3E6ScEf.