Good Clinical Practice (GCP) Training
NIH-funded Clinical Trials
Effective January 1, 2017, training in Good Clinical Practice (GCP) is required for all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials. GCP training must be refreshed every three years.
Note that GCP training complements human subjects protection training—both types of training must be completed.
Applicability
GCP training is required for the following individuals involved with an NIH-funded clinical trial:
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.
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.
Meeting Training Requirements
ISU has adopted the following GCP training courses offered through the CITI Program
First-time training
GCP – Social and Behavioral Research Best Practices for Clinical Research
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
Refresher training (every three years)
GCP SBR Advanced Refresher
GCP FDA Refresher
Those who complete the training are expected to retain documentation of completion and can log into the CITI Program at any time to obtain training records. Principal investigators are strongly encouraged to retain records of GCP training for clinical trial staff working on their projects.