NOT-OD-16-148 establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials (NIH definition of Clinical Trials) should be trained in Good Clinical Practices (GCP).
Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.
Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical trial staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
All investigators and clinical trial staff receiving CCTS support must complete GCP training. GCP training is available at no cost to investigators and their clinical trial staff through CITI GCP Training. Alternative GCP Training will be accepted with appropriate documentation of training. Please provide documentation of alternative GCP Training to firstname.lastname@example.org.
To access CITI GCP Training Modules:
Please use the link below to complete the CITI GCP training.
1. “Log in through my institution”
2. Chose University of Kentucky Courses
3. Login with Linkblue credentials
4. Click on University of Kentucky Courses
5. Click on Add a Course
6. Check IRB
7. Check Good Clinical Practice (GCP) Training
8. Check Initial Good Clinical Practice Training
9. Check one of the following options for GCP Training:
1. GCP Course for Clinical Trials Involving Investigational Medical Devices (ICH focus) course
2. Good Clinical Practice Course for Clinical Trials Involving Investigational Drugs (ICH/international focus)
3. GCP Course for Social and Behavioral Research Best Practices for Clinical Research
10. Course will be added to University of Kentucky Courses
11. Refresher training will be required every 3 years.