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Safety Reporting in Clinical Trials - Home | ClinRegs
Safety Reporting • SAHPRA/CTC requires stringent reporting criteria and timelines. • Safety reporting should be defined by the Applicant in the protocol and CTF1. • Certain clinical trials may require special and exceptional adverse event monitoring and reporting that will be specified by SAHPRA on a protocol-specific basis.
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GCP INSPECTION CHECKLIST - ClinRegs
clinregs.niaid.nih.gov1 ICH Guideline for good clinical practice, recommended for adoption at step 4 of the ICH process on 1 May 1996 2 Guidance on General Considerations for Clinical Trials (ICH-E8) 3 Guidelines for good clinical Practice (GCP) for trials on pharmaceutical products. WHO Technical Report Series, No. 850, Annex 3, 1995
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