Good Clinical Practice Training

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. It ensures the rights, safety, and well-being of participants and the credibility of clinical trial data.

GCP outlines the responsibilities of investigators, sponsors, monitors, and Institutional Review Boards (IRBs) and applies to both biomedical and behavioral research. 

GCP Matters

GCP ensures:

• Compliance with ethical and regulatory standards.
• Accurate and reliable data collection, monitoring, and reporting.
• Protection of human subjects throughout the research process.

Who Must Complete GCP Training?

Good Clinical Practice (GCP) training is mandatory for all personnel involved in NIH-funded clinical trials, industry-sponsored clinical trials that explicitly require GCP training in the clinical trial agreement, or clinical trials subject to FDA regulations. This includes individuals who:

• Design, conduct, oversee, or manage clinical trials.
• Recruit or consent participants.
• Collect or manage study data.
• Perform study-related procedures or assessments.
• Access identifiable participant data or biospecimens
• Contribute significantly to data management

Examples of required personnel:

• Principal Investigators
• Study Coordinators/Research Nurses/Clinical Research Coordinators
• Sub-Investigators
• Data Managers and Statisticians

Note: These personnel should be listed in the IRB application.

Local healthcare providers (HCPs) may support certain trial-related activities—such as routine clinical assessments or procedures - when these align with their standard scope of practice and do not require detailed knowledge of the study protocol, investigational product, or investigator’s brochure. According to FDA guidance on decentralized clinical trials, these providers are not considered study personnel or sub-investigators if their involvement is limited to standard clinical care or delegated tasks that do not involve investigational oversight or data interpretation. Such providers are not required to complete GCP training, provided their role does not extend beyond routine care or delegated procedures that fall within their existing qualifications and licensure. However, sponsors and investigators must ensure that any trial-related activities performed by local HCPs are appropriately documented, and that these individuals are trained for their specific responsibilities if those responsibilities go beyond standard care.

FAQs

What is a clinical trial?

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.

How often do I have to complete GCP training?

GCP training completed in CITI must be completed every three years. The clinical trial sponsor may require training more frequently, as specified in the clinical trial agreement.

How do I refresh my GCP training?

GCP training must be renewed every three years through completing the CITI GCP “refresher module” that is available for those who have completed the initial CITI GCP training. For those taking the GCP training module, the refresher course will auto-populate in the individual’s course menu 90 days before the training expiration date. CITI will send reminder emails beginning 90 days before the GCP expiration in CITI.

Does the ICH E6 Good Clinical Practice (GCP) guideline mandate GCP training for clinical trial personnel?

The ICH E6 Good Clinical Practice  (GCP) guideline does not explicitly mandate GCP training, but it strongly implies the need by emphasizing the qualifications and responsibilities of personnel involved in clinical trials.

Here’s what the ICH GCP guideline says:

• Section 2.8: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).”
• Section 4.1.1: “The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial...”
• Section 5.6.1: Sponsors are responsible for ensuring that trial-related duties and functions are delegated to appropriately trained individuals

So, while ICH GCP does not prescribe a specific training course, it clearly requires that all personnel involved in a clinical trial be appropriately trained to ensure compliance with GCP standards. In practice, this is often fulfilled through formal GCP training programs, such as those offered by CITI or provided by a sponsor.