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Relevant IRB Policies and Procedures

Effective January 1, 2017, Good Clinical Practice (GCP) training is required for all Fred Hutch personnel involved in the design, conduct, oversight, or management clinical trials conducted at Fred Hutch or through the Fred Hutch/University of Washington 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 clinical trial 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.

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.

Additional GCP training requirements for investigator-held IND/IDE multi-center studies:

Fred Hutch or UW Consortium "Sponsor-Investigators" who hold the Investigational New Drug (IND) or Investigational Device Exemption (IDE) for a multi-center study may be subject to additional training requirements by the Consortium's External Performance Site Assessment Committee (EPSAC). For more information on EPSAC visit the Cancer Consortium website.


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 such as the Association of Clinical Research Professional's GCP classroom training course or the Barnett Education Services GCP classroom training course. The IRB will accept other GCP training if the course covered the same topics as CITI and written documentation can be provided.

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;
  • Refresher GCP CITI web-based course:
    • GCP FDA Refresher, or 
    • GCP ICH Refresher;
  • Other equivalent GCP training provided by an industry sponsor or other organization may be accepted.

Go to Hutch Learning to access GCP curricula.


Documentation

Completion of CITI training is entered automatically in Hutch Learning. There may be up to a week delay for Hutch Learning to reflect your completion status. (Note, you have to associate to 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.