Good Clinical Practice (GCP) Training
Beginning in 2008, the FHCRC/UW Cancer Consortium is implementing a GCP training requirement for all sponsor/investigators, principal investigators and research staff that are involved in the design, conduct or reporting of therapeutic clinical studies and prevention studies that involve drugs, biologics or devices.
Examples of staff required to complete GCP training are:
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FHCRC statisticians involved in the protocol design, data analysis and interpretation of the data.
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FHCRC staff members involved in protocol development or conduct, including responding to operational issues such as protocol violations, conducting site training, and advising sites in data management.
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FHCRC management who may not be involved in the actual conduct of the protocol but are instead responsible for protocol design (e.g., developing and designing Case Report Forms required by the protocol).
Examples of staff exempt from GCP training requirement
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data entry staff
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programmers
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administrative staff
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 Good Clinical Practice (GCP) training plan. The memorandum dated February 08, 2008 describes the GCP training plan for 2008.
All FHCRC/UW Cancer Consortium sponsor/investigators, principal investigators and research staff that are involved in the design, conduct or reporting of therapeutic clinical studies and prevention studies that involve drugs, biologics or devices are required to successfully complete GCP training and provide documentation to the IRB.You are required to complete GCP training only once.
Training Options:
Collaborative Institutional Training Initiative (CITI): CITI offers on-line GCP training
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Other organizations offer classroom GCP training such as the Association of Clinical Research Professional’s GCP classroom training course and 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.
Documentation
Please send documentation of your completed training to the IRO (attn. Joshua Clark, mailstop J6-110; jeclark3@fhcrc.org
).Questions?
If you have questions about the GCP training requirements, please contact Nora Olsen nolsen@fhcrc.org
or 667-2870.|
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