FAQs about GCP Training
What is GCP?
Good Clinical Practice (GCP) is the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that the rights, confidentiality, and well-being of trial subjects, are protected.
What date will GCP Training at Dartmouth become mandatory and who needs to complete it?
As of December 31, 2010, GCP training will be required for all Dartmouth PI's and Key Personnel conducting clinical trial research. Beginning Jan. 1, 2011, a study will NOT be approved to proceed until the training requirement for the research team is met. For more details see the GCP Memo attached above.
Is GCP required for Studies that are Exempt or Expedited?
No, GCP training is not required for new studies that are determined to be Exempt or Expedited by Dartmouth's Committee for the Protection of Human Subjects (CPHS). Only clinical trial research needing Full Committee CPHS review requires GCP training.
Who Are Key Personnel?
"Key Personnel" are individuals responsible for protocol development, design, conduct, or reporting of research. Sub-Investigators, fellows, medical residents, research nurses, study coordinators, regulatory specialists are considered key personnel. If you are unsure whether you or someone on your study team needs to take GCP, please contact the CTO at (603) 653-3411 or CTO@Hitchcock.org.
How long will it take to complete the GCP course?
The average length of time required to take the CITI GCP training is approximately 4-6 hours. Each GCP module has text to read and a quiz to complete. You do not have to complete the course in one session. You may leave and come back to the site using your CITI username and password. A minimum aggregate score of 80% is required to pass the GCP Course.
Will I receive a certificate after completing the CITI training?
Yes. It is suggested that you print or download a Course Completion Report as evidence that you have met your institutional GCP training requirement. A copy will be sent automatically to the CTO. You may return to the course site in the future to obtain a copy of the completion report and/or to complete additional training, as necessary.
Will alternative GCP Courses satisfy the requirement?
No, effective 7/1/2013 CITI is the only approved training method to complete the GCP training requirement.
Do I need to take GCP if I already completed Human Subjects training?
Yes, you must complete GCP training even if you have completed Human Subjects training provided by the Dartmouth Committee for the Protection of Human Subjects (CPHS). GCP covers areas that these other training programs do not.
How Do I Access the CITI GCP Course?
Can I receive CME Credits for Completing the GCP Training?
The CITI GCP course provides the opportunity to receive CME credits for a small fee. https://www.citiprogram.org/citidocuments/cme/index.htm
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