ICH-GCP Information

Overview

The International Conference on Harmonization (ICH) works to standardize clinical research on a global scale. Their Good Clinical Practice (GCP) guidelines are the gold standard for clinical trials and must be followed if you have stated that you will use them in your protocol or contract. 

Even if you did not state that you will follow the guidelines, they still provide a basis for best practices. If you are conducting a clinical trial at U-M, you are required to document that key personnel have received GCP training.

In this section you will find additional information about ICH guidelines and the requirements for GCP at U-M.


Links

Guidelines
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. ICH-GCP standards are fully described in this efficacy guideline document.

U-M IRBMED – Instructional for ICH-GCP Clinical Trials
IRBMED provides instructions for clinical trials conducted according to ICH-GCP E6.

Human Research Protection Program Policy
All study team members involved in the design, conduct, recording, or reporting of an active NIH-funded clinical trial must be GCP-certified through a qualifying training provider.


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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