Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify
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| Document information | |
|---|---|
| Reference | GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL |
| Version / Revision | 08-Jul-2020 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.1.4 |
| Scope | HM |
| Document part | D
Who should notify |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious breach, Sponsor, CRO, Authorised representative, Written agreement |
Content
D. Arrangements for notification Who should notify? The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a legal representative or contract research organisation (CRO)), if this function has been delegated by the Sponsor to another party. In accordance with Statutory Instrument 2004/1031 as amended by Statutory Instrument 2006/1928, the Sponsor retains legal responsibility even if the function is delegated (Regulation 3.12). The CRO is also legally responsible for compliance with the legislation in relation to functions delegated by the Sponsor to the CRO (Regulation 3.8). However, in the interests of subject safety, reporting should not be delayed by discussion over reporting responsibility. [...]
