Good Clinical Practice Training

Good Clinical Practice (GCP) is an international, ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.

Northwestern University and the Feinberg School of Medicine require GCP training for all investigators, co-investigators and study personnel listed on the Northwestern University IRB application and involved in research defined as follows by the NIH clinical trial definition: "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 interventions on health-related biomedical or behavioral outcomes.:

To meet the GCP training requirement, you must complete one of the following:

• CRC Basic Training Course
• CITI GCP Course (please note that the CITI Human Subjects Protections course does not fulfill the requirement)
• NIH Clinical Research Training online from the Office of Clinical Research Training and Medical Education
• NIH GCP for Social and Behavioral Research
• Industry-sponsored GCP training approved by TransCelerate

If you are already trained from an outside resource and have a certificate of proof, please submit proof of training compliance to REDCap for review and tracking.