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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)

Annex IV CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL

United Kingdom

Original text. Later amendments are not shown.

The summary of the results of the clinical trial shall contain information on the following elements:

ACLINICAL TRIAL INFORMATION:
BSUBJECT DISPOSITION:
CBASELINE CHARACTERISTICS:
DEND POINTS:
EADVERSE EVENTS:
FADDITIONAL INFORMATION:

← Division 25

Annex IV

Legislation: 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)
Citation: EU Regulation No 536/2014, annex iv
Official version: legislation.gov.uk

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Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives. legislation.gov.uk is the official version.

Not legal advice.

👋 Jason Cartwright
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