Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. 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. The FHCRC/UW Consortium has developed a GCP training plan. The memorandum dated February 08, 2008 describes the original implementation of the GCP training plan.
Who needs training?
GCP training is required for all FHCRC personnel involved in one or more of the following aspects of a clinical intervention or prevention trial testing the use of an FDA regulated drug, biologic, and/or device:
Examples of FHCRC personnel required to complete GCP training are:
Examples of staff generally not required to complete GCP training:
It depends on your role. If you are the principal investigator on a study submitted to the FHCRC IRB, or you are relying on the FHCRC IRB through an Individual Investigator Agreement you need to meet the FHCRC's GCP training requirements.
Other non-FHCRC 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 the IRB Training Policy.
How often do I need training?
You are required to complete GCP training only once. However, GCP training can be repeated to satisfy the Human Subject Protections refresher training requirements.
Additional GCP training requirements for investigator held IND/IDE multi-center studies:
FHCRC 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.
Please send documentation of your completed training to the IRO department (attn. Admin Assistant for Human Subjects Training, mailstop J2-100).
If you have questions about the GCP training requirements, please contact Nora Olsen firstname.lastname@example.org or 667-2870.