EU’s Requirements for Returning Trial Results
Ten elements needed
The EU’s European Clinical Trial Regulation requires clinical trial sponsors to create layperson-friendly content for the summary of results. Here are the required 10 elements:
- Clinical trial title, protocol number, EU trial number, and other identifiers.
- Sponsor’s name and contact information.
- General clinical trial information, including where and when the trial was held, its main objectives, and why it was conducted.
- Information on the subject population, including the number of people included in the EU member state concerned, in the EU, and in other countries, as well as the age and gender breakdown and inclusion/exclusion criteria.
- Investigational medicinal products used.
- Description of adverse reactions and their frequency.
- Clinical trial’s overall results.
- Comments on the clinical trial’s outcome.
- Indication if follow-up clinical trials are foreseen.
- Where to find additional information.1
REFERENCE
- Brauburger K, Sroka-Saidi, K, Schindler TM. AMWA. 2015;30(2):60-63.
The EU’s European Clinical Trial Regulation requires clinical trial sponsors to create layperson-friendly content for the summary of results.
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