ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

place to ensure that user access and assigned roles and permissions are periodically reviewed, where relevant.

(c) Authorised users and access permissions should be clearly documented, maintained and retained. These records should include any updates to a user’s roles, access permissions and time of access permission being granted (e.g., time stamp).

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