Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13
From GxPlex
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.2.3 |
| Scope | G |
| Document part | A4.13 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data protection, Remote access, Systems validation |
Content
The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records are highly sensitive) and to the access rights to be granted (read-only, write or even 'admin' rights)
