# 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), Division C: BASELINE CHARACTERISTICS:

Extent: E+W+S+N.I.

1.. Baseline Characteristics (Required) Age;
2.. Baseline Characteristics (Required) Gender;
3.. Baseline Characteristics (Optional) Study Specific Characteristic.

---
Source: https://www.legislation.gov.uk/eur/2014/536/annex/IV/division/C (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-IV/division-C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.