Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16

Document Information

Document information
Reference	GBR Directive 2001/20/EC 04-Apr-2001
Validity area	GBR
Scope(s)	HM
Document name	Directive 2001/20/EC
Version / Revision	04-Apr-2001
Status	Current
Document type	Legal act
Language(s)	EN
Description	DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU.
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	HM
Document part	Article 16
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Investigator obligation to report all SAEs immediately

Text

Notification of adverse events 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter.

2. Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.

3. For reported deaths of a subject, the investigator shall supply the sponsor and the Ethics Committee with any additional information requested.

4. The sponsor shall keep detailed records of all adverse events which are reported to him by the investigator or investigators. These records shall be submitted to the Member States in whose territory the clinical trial is being conducted, if they so request.