The More You Know: Good Clinical Practice (GCP) Training Requirement

As of January 1, 2017, NIH requires all NIH-funded clinical investigators or clinical trial staff who are involved in the design, conduct, oversight or management of clinical trials to undergo Good Clinical Practice training. GCP training can be obtained through a class or course, academic training program, or certification from a recognized clinical research professional organization and must be renewed every three years to remain compliant with regulations, standards and guidelines. VUMC requires all key study personnel on new IRB applications and continuing review requests to have completed GCP training. VUMC offers the following methods for completing this training: Via the Learning Exchange for Social or Behavioral Sciences (select “VUMC”) Via the National Drug Abuse Treatment (NDAT) Clinical Trials Network for Health and Biomedical Sciences Via the CITI GCP course, NIAID GCP training, and NIDA GCP training Certification of training must be kept readily available to provide to NIH upon request. Although GCP training counts towards human subjects training for the purposes of IRB applications, it does not change the

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Human Subjects Training

Who? – Investigators, key study personnel, students, and faculty advisors conducting human subjects research Why? – For awards that have human subjects, OSP must certify that key study personnel working with human subjects or human subjects data have training on file with VHRRP How often? – Continuing education course must be completed annually. Approved courses include: Educational sessions approved by VHRPP National conferences that address human subjects protections in research CITI refresher courses Optional CITI courses The basic CITI course must be retaken every four years Where? – CITI training status can be found in the DISCOVR-E portal: Log-in to DISCOVR-E Click on the “Training expires in:” gauge (displays IRB training status and expiration date) OR Click on “View IRB Training”