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Good Clinical Practice (GCP)

GCP Overview

Good Clinical Practice (GCP) is an international standard for the conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical and FDA-regulated human subject research.  The standards provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of human subjects are protected.

GCP standards are set by the International Council for Harmonisation (ICH).  FDA expects implementation of GCP standards for studies generating clinical trial data.  NIH expects investigators conducting clinical trials to be trained in GCP standards. 

GCP Applicability

The following types of human subject research must implement standards of GCP as applicable to the study:

- Studies involving INDs - Investigational New Drugs

- Studies involving SR (Significant Risk) Device IDEs - Investigational Device Exemption

- Studies involving NSR (Non Significant Risk) Devices

- Studies meeting the NIH Definition of Clinical Trial

GCP Toolkit

To assist with implementation of GCP standards and documentation requirements (often referred to as the "Regulatory Binder"), please refer to the following toolkit with a collection of guidance, checklists, and resources.

This document lists all the required GCP documents, an explanation of the purpose for each, and links/guidance to templates and examples.

These checklists convert all the required doucments into 3 checklists to use before, during, and after the study. The checklists can be used to note the format of each record, where it's located/stored, and who in the lab is responsible for maintaining it. It is recommended to fill out the Checklist(s) and store it in the Regulatory Binder.

GCP Training

For IRB protocols meeting the types of studies in the GCP Applicability section above, research team members are required to complete GCP training prior to approval of the protocol. Click here for full GCP training instructions: