Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16: Difference between revisions
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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.
