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.
One of the options for GCP training available free to U-M faculty and staff is the Collaborative Institutional Training Initiative (CITI) program.
Collaborative Institutional Training Initiative (CITI) Program - Good Clinical Practice Course
The CITI Program’s GCP for Clinical Trials with Investigational Drugs and Medical Devices - U.S. FDA course is designed specifically for clinical researchers participating in human subjects research to have an understanding and knowledge of the federal regulations, International Conference for Harmonisation (ICH) Regulations, and Good Clinical Practice guidelines that apply to clinical research.
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