Good Clinical Practice (GCP) training is required for external personnel listed on a research study that meets the NIH definition of a clinical trial if they are involved in identifying/recruiting subjects, obtaining informed consent, or interacting with subjects. See the below for which training(s) are acceptable.
Select each tab below to learn more.
External personnel involved in drug/device clinical trial research
External personnel involved in drug/device clinical trial research can complete either of the following:
- “Good Clinical Practice for Drug/Device Researchers” via CITI by registering and affiliating with University of Wisconsin- Madison as described above in the “Human Subjects Protections Training” section. However, you will use question 3 under “Select Curriculum” to select “Good Clinical Practice for Drug/Device Researchers.”
- National Institutes of Health (NIH) offers Good Clinical Practice training for Drug/Device researchers via the National Institute on Drug Abuse.
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- External personnel should create their own account and provide certificate to the UW study team.
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- Users can redo the training every three years to maintain training.
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External personnel involved in clinical trials that do not involve drugs/devices
External personnel involved in clinical trials that do not involve drugs/devices can complete either of the GCP trainings described in the drug/device section or either of the following:
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- “GCP – Social and Behavioral Research Best Practices for Clinical Research” via CITI by registering and affiliating with University of Wisconsin- Madison as described above in the “Human Subjects Protections Training” section. However, you will use question 3 under “Select Curriculum” to select “GCP – Social and Behavioral Research Best Practices for Clinical Research.
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- NIH GCP training for Social/Behavioral researchers via the Society of Behavioral Medicine.
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- External personnel should create their own account and provide the completion certificate to the UW study team.
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- Users can redo the training every three years to maintain training.
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- NIH GCP training for Social/Behavioral researchers via the Society of Behavioral Medicine.