Minimum Criteria for ICH E6 GCP Investigator Site ...
• Document the acceptance to follow protocol in a protocol signature page or contract. • Protocol deviation process - no deviations or changes prior to sponsor and IRB/IEC approval/ ... • Adverse Event (AE) definition (1.2). • Refer to or add definition of ADR (1.1) and Unexpected ADR (1.60). ................
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