This policy takes effect January 1, 2017. The Good Clinical Practice (US FDA Focus) Course may not be used to satisfy Ohio State requirements for training in human subjects protection. Print and retain a copy of the completion report for your records.
http://orrp.osu.edu/irb/training-requirements/good-clinical-practices/
Regulatory requirements for GCP Training. While most of the regulatory agencies do not specify exact requirements for GCP training, if your clinical team is not performing according to GCPs, FDA or the others can cite inadequate GCP training as an observation.
http://www.kentassocinc.com/regulatory-requirements-for-gcp-training.htm
NIH leadership released a new policy requiring GCP training as of January 1, 2017 (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html). There are three important components of this policy that may require some research teams to take additional GCP training:
http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/gcp_training.html
The CITI Good Clinical Practice (US FDA Focus) Basic and Refresher Courses can be used to meet this requirement. The CITI Basic Human Research Course is a prerequisite for taking the GCP Course. Formal GCP training for clinical investigators is not currently required by the University.
http://orrp.osu.edu/irb/training-requirements/good-clinical-practices/
• Provide a brief description of the required courses. • Identify training(s) required for your specific role. The Belmont Report. All employees, faculty, staff, students and/or agents of Emory University. engaged in the conduct of human subject research must have reviewed and be. familiar with the principles of “The Belmont Report: Ethical Principles and.
http://www.irb.emory.edu/documents/IRB-Training-Requirements-PDF.pdf
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.
http://med.dartmouth-hitchcock.org/clinical_trials/faqs_gcp_training.html
Many NIH clinical trial groups already require GCP training, as do some corporate sponsors. To avoid confusion, our Johns Hopkins Medicine policy will require up-to-date GCP training for the entire research team, including staff, on all clinical trial protocols no matter who is funding the research.
http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/gcp_training.html
While the new JHM policy only applies to individuals conducting clinical trials, GCP training is relevant to all types of clinical research and will count as a component toward the more general Human Subjects Research Training recertification requirements.
http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/gcp_training.html
When evaluating GCP training, we need to look for the duration of the course. A one hour GCP course can't cover but one small aspect of GCPs. A minimum of 8 hours, preferably 16 hours of lecture and workshop activity to ensure a working knowledge of the GCP requirements is preferred.
http://www.kentassocinc.com/regulatory-requirements-for-gcp-training.htm
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.
http://med.dartmouth-hitchcock.org/clinical_trials/faqs_gcp_training.html
is gcp training required
No, Good Clinical Practice training is not required.