Reference:GBR MHRA GCP Inspection Dossier template V7.0 -
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| Document information | |
|---|---|
| Reference | GBR MHRA GCP Inspection Dossier template V7.0 |
| Validity area | GBR |
| Scope(s) | G |
| Document name | MHRA GCP Inspection Dossier template |
| Version / Revision | V7.0 |
| Status | Current |
| Document type | Information from official body |
| Language(s) | EN |
| Description | GCP Inspection Dossier template
The following information is requested specifically in relation to clinical trials undertaken (for Investigational Medicinal Products) within the UK and should be provided within 30 days of the advance notice email date. Note: the scope of the dossier request will be determined in the notification email you have received. If your organisation has been selected for a systems inspection, this dossier should be completed with all trial activities in scope. If you have been informed of our intention to conduct a trial specific inspection the dossier (and associated attachments) should be related to the selected trial(s) only. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 7 — Unit 7.0.0 |
| Scope | G |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Artificial intelligence, Inspection, MHRA, Good clinical practice |
| Comment | Questions related to AI use in the MHRA Inspection Dossier template |
Content
GCP Inspection Dossier template […] 13. Artificial Intelligence and Machine Learning Please explain where artificial intelligence and/or machine learning is utilised in your organisation for the delivery or management of clinical trials. […]
