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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance article annex_V CELEX: 02014R0536-20221205 CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS
The summary of the results of the clinical trial for laypersons shall contain information on the following elements:
1. Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);
2. Name and contact details of the sponsor;
3. General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);
4. Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria);
5. Investigational medicinal products used;
6. Description of adverse reactions and their frequency;
7. Overall results of the clinical trial;
8. Comments on the outcome of the clinical trial;
9. Indication if follow up clinical trials are foreseen;
10. Indication where additional information could be found. |