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GCP Training for NIH-funded researchers 

 

NIH has recently enacted a policy, effective January 1, 2017, requiring clinical investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

 

To comply with these requirements, all investigators and research staff members within the College of Medicine funded by or involved in an NIH-supported study meeting the definition of a clinical trial are required to complete GCP training.

 

A clinical trial is defined by NIH as a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those intervention on health-related biomedical or behavioral outcomes.”

 

Investigators and staff are required to take one of the following GCP trainings through the Collaborative Institutional Training Initiative (CITI) Program to satisfy the requirement:

Biomedical Research: “Good Clinical Practice and ICH”

Social or Behavioral Research: “Good Clinical Practices for Social and Behavioral

Researchers”

 

Training taken through CITI will be automatically recorded in ORRP database. 

 

For questions related to this new NIH-imposed training requirement, please contact the College of Medicine Office of Research.​ 

 

Posted on 24-Oct-17 by Larsen, Abigail
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