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Good Clinical Practice (GCP) Training Requirements
The National Institute of Health (NIH) has established a new directive regarding the training of investigators and staff involved in the conduct, oversight, or management of any NIH funded clinical trial.
As of January 1, 2017, any investigator, clinician or resident, clinical trial staff, student (undergraduate and/or graduate), or postdoctoral fellow responsible for study coordination, data collection, or management must complete Good Clinical Practice (GCP) training. This requirement must be met regardless of whether the trial is biomedical or social science in nature. West Virginia University provides GCP training through the CITI Program.
Completing GCP Training
Registering a CITI Account
New users can create a CITI account. From the main page, click the ‘Register’ button in the top right section of the screen. When creating your account, be sure to select West Virginia University as your affiliate institution.
Previously Registered WVU Affiliate
If you already have a CITI account you may log into the site by clicking the ‘Log In Through My Institution’ option, at the top of the homepage and selecting West Virginia University from the list. You will use your WVU ID to log into the site. You can also click the ‘CITI Login’ button at the top of this screen.
Afterwards, add the GCP course to your curriculum and complete the training. There is no need to create a new account, specifically to finish the GCP training. GCP courses offered by WVU can be found under Question 7 of the ‘Add a Course’ area of your CITI account.
The course that should be completed is titled GCP (Good Clinical Practice) (Human Subject Research).
Previously Registered Non-WVU Affiliate
If collaborating with researchers from outside of WVU, they will need to either: a) affiliate with West Virginia University and complete the steps above to add the course to their curriculum, or b) if the training is previously completed while affiliated with their home institution, they can submit a valid completion certificate for the GCP training.