Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
From GxPlex
| 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I | HM | Appendix I | EN | [...]
6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported? If a serious breach is identified at … |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II | HM | Appendix II | EN | Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)… |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution | HM | D Investigator/Institution | EN | [...]
Investigator/Institution: The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to i… |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported | HM | D What needs to be reported | EN | What needs to be reported?
• Any serious breach of: (a) The conditions and principles of good clinical practice in connection with that trial (as def… |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made | HM | D When should the notification be made | EN | […]
When should the notification be made? • Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated… |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify | HM | D Who should notify | EN | D. Arrangements for notification
Who should notify? The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a… |
