Good Clinical Practice (GCP) Training

ATTENTION: The NIH recently announced new GCP training expectations that must be met by January 1, 2017. The new policy requires basic GCP training and refresher GCP training every three years. The policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.

The leadership at Fred Hutch and across the Cancer Consortium has determined that all Fred Hutch and Consortium investigators and staff involved in clinical trials, regardless of funding source, will be required to meet the new GCP training requirements as of January 1, 2017. The Fred Hutch or UW Cancer Consortium Principal Investigator of a clinical trial is responsible for ensuring that GCP training has been taken by staff supporting the clinical trial.

If you have documentation or certification that you have taken GCP training prior to January 1, 2014, you will need to take a GCP refresher course prior to January 1, 2017.

List of GCP training courses and GCP refresher courses.

Click here to check your current training records.

Please note, the Institutional Review Office and the Clinical Research Support Office will be updating their policies and procedures on January 1, 2017 to account for these changes to GCP training requirements. If you have questions or need further assistance with this new GCP training requirement, please contact the IRO@fredhutch.org or CRScustomerservice@fredhutch.org.

Summary

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected. 

Who needs training?

GCP training is required for all Fred Hutch investigators and clinical trial staff involved in a clinical trial, regardless of funding source.

If my primary affiliation is with another institution, do I need to meet the Fred Hutch GCP training requirements?

It depends on your role. If you are the principal investigator on a study submitted to the Fred Hutch IRB, or you are relying on the Fred Hutch IRB through an Individual Investigator Agreement you need to meet the Fred Hutch's GCP training requirements. 

Other non-Fred Hutch investigators and study staff should meet the requirements of their own institution; the PI is responsible for ensuring all study staff have met the relevant institutional requirements. For more detailed information on who needs to complete GCP training see IRB Policy 2.20 Training.

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 trial 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 web-site.

Training Options:    

Documentation:

Please send documentation of your completed training to iro@fredhutch.org.

Questions?

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

 

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