Good Clinical Practice

Relevant IRB Policies and Procedures

• IRB Training (Policy 2.20)

Good Clinical Practice (GCP) training is required for all Fred Hutch personnel involved in the design, conduct, oversight, or management of clinical trials conducted at Fred Hutch or through the Fred Hutch/University of Washington/Seattle Children's Cancer Consortium. Training must be completed every three years. For additional information, refer to the training policy above.

GCP Training Requirements

GCP training is required for all Fred Hutch investigators and research staff involved in a clinical trial. Definitions:

Clinical Trial

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.

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.

Research Staff

Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of research 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. Research staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

Course Options

Basic GCP Training

You need to take a basic course if you have never had GCP training before. Accepted courses include:

• CITI web-based course (basic GCP courses only):
  • Good Clinical Practice for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus), or 
  • Good Clinical Practice for Clinical Trials with Investigational Drugs and Biologics (ICH Focus);
• GCP training offered by Institutes within the NIH, including NIAID and NIDA.
• Any TransCelerate-approved GCP training course.
  
• For social-behavioral GCP training, an NIH-developed course is available on Hutch Learning or through the Society of Behavioral Medicine.
• Other equivalent GCP training provided by an industry sponsor or other organization may be accepted. Upon request, Clinical Research Support (CRS) and/or IRO staff will review the training and determine whether the course is acceptable.

Refresher GCP Training

You need refresher training within 3 years after completing a previous GCP course. Accepted courses include:

• Retaking any basic GCP training course listed above;
• CITI online refresher course:
  • GCP FDA Refresher or 
  • GCP ICH Refresher
• Other equivalent GCP training provided by an industry sponsor or other organization may be accepted. Upon request, Clinical Research Support (CRS) and/or IRO staff will review the training and determine whether the course is acceptable.

Documentation

CITI training completions are entered automatically in Hutch Learning. There may be up to a week delay for Hutch Learning to reflect your completion status. (Note, learners must affiliate with Fred Hutch when enrolling in CITI courses for completion to be accurately recorded.) If you have taken other training that meets the GCP training requirements, please send documentation to iro@fredhutch.org.

Questions?

If you have questions about the GCP training requirements, please contact iro@fredhutch.org or CRScustomerservice@fredhutch.org.