ICH Guidances

The Links below provide important information and guidelines on best clinical research practices:

E6: Good Clinical Practice: Consolidated Guideline

The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH Process in November 2016.

The 1996 ICH Guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The current amendment (ICH E6(R2)) aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. This amendment now enters into the implementation period (Step 5).

ICH E6(R2): Guideline for Good Clinical Practice (GCP)

E2A: Clinical Safety Data Management Definitions and Standards for Expedited Reporting
E8: General Considerations for Clinical Trials

Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans