Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447: Difference between revisions
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Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 | Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 | ||
Revision as of 12:54, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR Guidance
Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 |
| Validity area | GBR |
| Scope(s) | G |
| Document name | Guidance
Access to Electronic Health Records by Sponsor representatives in clinical trials |
| Version / Revision | 2021-09-08 00:00:00 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance
Access to Electronic Health Records by Sponsor representatives in clinical trials The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - | G | - | EN | Remote direct access to Electronic Health Records (EHR) by Sponsor Monitors (or Auditors) in clinical trials
[...] Remote direct access to the health … |
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security | G | System Security | EN | System Security
[...] There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; pass… |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - | G | - | EN | Remote direct access to Electronic Health Records (EHR) by Sponsor Monitors (or Auditors) in clinical trials [...] Remote direct access to the health records of clinical trial participants may be ... |
| Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security | G | System Security | EN | System Security [...] There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; password criteria and renewal rules, firewalls, virus ... |
