In effect since January 1, 2017, NIH's Good Clinical Practice (GCP) policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of NIH clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
What is a “clinical trial” according to NIH? If you answer “yes” to all of the following questions, you are conducting a “clinical trial” and GCP training is required.
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Is your study funded by the NIH?
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Does the study involve human participants?
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Are the participants prospectively assigned to an intervention?
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Is the study designed to evaluate the effect of the intervention on the participants?
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Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
Options to fulfill GCP training requirement
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Access resources for online trainings via the NIH website.
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Utilize the Good Clinical Practice Field Guide for Social Behavioral Researchers (paper-based).
The IRB office has developed a paper-based GCP training based on the NIH’s eLearning course to make it more accessible to data collectors and study team members for whom the online CITI or NIH courses are not appropriate or not accessible.
The goal of this course is to introduce good clinical practice (GCP) principles to clinical and/or community-based research investigations involving human subjects as they specifically apply to social and behavioral research.
Please click here for a pdf version of the training.
Included with this training is a quiz, answer sheet for the quiz, as well as a training completion sheet that is to be submitted along with your IRB application to provide documentation of training. Those that take the quiz are expected to attain an 80% passing score.