New NIH Policy for Good Clinical Practice (GCP)
NIH has released a policy on Good Clinical Practice (GCP) Training for NIH Awardees involved in NIH-funded Clinical Trials.
This policy went into effect on 1/1/2017.
NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials are required to be trained in GCP. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Recipients of GCP training are expected to retain documentation of their training. It is the responsibility of the individual research team member to complete and maintain documentation of this training. Beginning 6/1/2017, NIH-funded clinical trials will be randomly selected to have their study team's GCP training confirmed.
A clinical trial is defined by NIH 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 evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Courses that will be accepted at University of Maryland, Baltimore are:
- CITI Good Clinical Practice and ICH, completed under University of Maryland Baltimore or Baltimore VA affiliation;
- CITI Good Clinical Practice (US FDA Drug and Device Focus), completed under University of Maryland Baltimore affiliation;
- National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice course. This course can be completed by those who conduct NIH funded social-behavioral research even without a drug abuse focus; OR
- Other GCP training will be accepted as meeting the requirement if the course is approved by TransCelerate.
If completing the one of the CITI course options, learners will need to log in to their already existing CITI account (CITIprogram.org) and add the course. The third option can be accessed at gcp.nihtraining.com. Learners will need to create a login account and complete the course. A listing of Transcelerate-approved GCP courses can be located at http://www.transceleratebiopharmainc.com/gcp-training-attestation/#headline4.
For questions, please call the University of Maryland Baltimore Human Research Protections Office at 410-706-5037. Thank you.