Additional training for NIH funded clinical trials
All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be training in Good Clinical Practice (GCP). A clinical trial is defined as 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 evaluation the effects of those interventions on health-related biomedical or behavioral outcomes. For more information regarding the GCP training policy and the definition of clinical trial, please click here. The GCP training is an additional requirement; it does NOT replace the Protections of Human Participants training.
The CITI program offers two courses that are acceptable GCP training by the National Institute of health in fulfillment of their GCP training policy. You can take either one of them:
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
(Suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
(Suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum.)
Please click here if you wish to know more about these courses.
To take the GCP training, for MIT Faculty, staff, or students: Please log into the CITI site via the MIT portal. You will need an MIT personal certificate for authentication. If you do not have a valid MIT certificate, you can get one here. For non MIT personnel: Please log into the University of Miami CITI site. When registering for the course, select 'Massachusetts Institute of Technology - Affiliates' as your institution.