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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
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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.
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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
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== References ==
{| class="wikitable"
! 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 ...
|}
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Latest revision as of 14:15, 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

 ScopeDocument partLanguagePreview
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 -G-ENRemote 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 SecurityGSystem SecurityENSystem Security

[...]

There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; pass…
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