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New NIH training policy (NOT-OD-16-148) effective January 1, 2017
The National Institutes of Health (NIH) will require study team members responsible for the conduct, management, and oversight of NIH-funded clinical trials to complete good clinical practice (GCP) training consistent with the principles of the International Conference on Harmonisation (E6). This new policy applies to all active clinical trials.
The University of Michigan offers a variety of educational opportunities and resources for U-M investigators, students and staff involved in human subjects research.
U-M's online Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) offers two courses that fulfill regulatory requirements for training in the protection of human subjects in research. U-M employees and students have access to the PEERRS menu in U-M's My LINC training system via their uniqname and UMICH (level 1) password. Completion of at least one of these courses is a requirement for IRB approval.
- Human Subjects Protection - Biomedical & Health
- Human Subjects Protection - Social & Behavioral
These courses are modeled on the Collaborative Institutional Training Initiative (CITI) human subjects protection modules.
U-M offers two options for basic good clinical practice (GCP) training for clinical trial study team members:
- For biomedical clinical trails, U-M offers GCP training through the Collaborative Institutional Training Initiative (CITI). To access the CITI GCP course, you must first create a CITI account (free) and affiliate with the University of Michigan within CITI. See the CITI step-by-step instructions for details.
- For social/behavioral clinical trials, the Michigan Institute for Clinical & Health Research (MICHR) offers the NCATS Social and Behavioral Best Practices course in My LINC. All U-M employees and students have access to U-M's My LINC training system through their uniqname and UMICH (Level 1) password. See the My LINC step-by-step instructions for details on how to register for the MICHR GCP course.
U-M expectations for fulfilling NIH GCP requirement
- All study team members involved in the design, conduct, recording, or reporting of an active NIH-funded clinical trial must be GCP certified through a qualifying training provider (e.g., CITI, MICHR/My LINC)
- Administrative Staff on an NIH-funded clinical trial are not required to complete GCP, unless directed to do so by the principal investigator on a project or per unit-specific (e.g., clinical trial support unit) business process
- The study team member is responsible for obtaining a GCP certificate displaying the course completion date, and providing that certificate upon request of the research sponsor, the institutional review board (IRB), or other institutional oversight units.
- GCP training must be renewed every three (3) years upon initial certification expiration, as long as the study team member is involved on an active clinical trial.
Other qualifying GCP training providers
U-M accepts GCP training from the following:
- Industry sponsors (e.g., organizations, etc. registered with TransCelerate Biopharma Inc.'s GCP Training Mutual Recognition program)
- Federal sponsors (e.g., NIH's NIAID GCP or National Drug Abuse Treatment Clinical Trials Network GCP)
- Recognized clinical research professional organizations (e.g., SOCRA's GCP workshop)
- GCP courses offered through other U.S. institution affiliation within CITI
The following U-M departments offer courses, seminars, workshops, etc. that cover regulatory overviews and specific human subject protection procedures.
- IRB-HSBS Education
- IRBMED Education
- University of Michigan IRB Collaborative (U-MIC) - online resources
- MICHR Education & Training (for faculty, staff, and postdoctoral students)
- Research Administrators Network (RAN) - mostly applicable to those administrators who work on funding proposals and financial monitoring of awards, but compliance information and processes may be covered.
To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to firstname.lastname@example.org.
For help with GCP training courses (e.g., registration, navigation):
- CITI: 888-529-5929 (U.S. toll free), email@example.com
- My LINC: ITS Service Center - 734-764-4357, 4Help@umich.edu