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The ICH Harmonised Tripartite Guideline for Good Clinical Practice defines a CRF as: 'A printed, optical or electronic document designed to record all of Essential documents for the conduct of a clinical trial ; 8.2.1. INVESTIGATOR'S BROCHURE ; 8.2.2. SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT16.1.2 Sample case report form (unique pages only) . 16.3 Case Report Forms . The ICH Guideline on Clinical Safety Data Management, Definitions and The ICH-GCP Guideline glossary defines a 'case report form' (CRF) as: 'A printed, optical, or electronic document designed to record all of the protocol