Clinical Research Organizations

What arrives

Part 11 audit trails
21 CFR 11.10(e). Secure, computer-generated, time-stamped audit trails recording operator entries and actions that create, modify or delete electronic records.
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Part 11 credentials
21 CFR 11.300. Controls on identification codes and passwords, checked, recalled or revised periodically, with loss management for compromised credentials.
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ICH E6(R3)
ICH E6(R3) Good Clinical Practice, adopted 6 January 2025. Computerised systems used in clinical trials fit for purpose, through risk-based validation where appropriate.
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A researcher in a white coat pipetting inside a laboratory hood, seen in profile.

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