Good Clinical Practice (GCP) Training
Good Clinical Practice Overview and Training
UCCS offers social and behavioral and biomedical basic good clinical practice (GCP) training via Collaborative Institutional Training Initiative (CITI) for researchers and team members involved in a clinical trial study/project. GCP CITI training is required for active NIH-funded clinical trials. Be aware NIH has changed the how they define a clinical trial see the resources below for more information about required training and how the NIH defines a clinical trial.
UCCS expectation for fulfilling NIH GCP requirements:
- All study team members involved in the design, conduct, recording, or reporting of an active NIH-funded clinical trial must be GCP through a qualifying training provider (e.g., CITI);
- 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 training displaying the course completion date, and providing that certificate upon request of the research sponsor or the institutional review board (IRB);
- 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. Most studies at UCCS should be able to take the GCP- Social and Behavioral Research Practices for Clinical Research. See the training documents below to learn how to sign up.
- NIH Good Clinical Practice Training
- NIH Definition of Clinical Trial
- NIH Why the Changes
- NIH Clinical Trial-Specific Review Criteria
- NIH NOT OD 18-212 Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants (7/20/2018)
- NIH Basic Experimental Studies with Human Subjects (BESH)
- NIH NOT OD 19-024 Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans (BESH) (10/26/2018)
- NIH Basic Science Studies Involving Human Participants (BESH) Guidance