General Article


June 16, 2005

Courses in good clinical practices

Web-based training modules provide 'excellent overview' of best practices

Web-based training courses on good clinical practices (GCP) are available for any member of the Hutchinson Center/University of Washington Cancer Consortium involved in human-subjects research. The courses are offered through the Clinical Trials Support Office, one of the eight resources housed within the Research Trials Office. Ten new modules have been added to the server under the heading, "Clinical Research Training for Investigational Site Personnel — CRISP." These modules are attached to Continuing Medical Education/Continuing Nursing Education (CME/CNE) credits.

The courses provide clinical researchers with a foundation in the international standards for the design, conduct, recording and reporting of trials that involve human subjects. Such standards are designed to protect the rights, safety and well-being of trial participants and ensure the quality and integrity of data obtained from clinical trials.

Linda Bakke, Research Trials Office director, said that while the course is not required, federal oversight agencies including the United States Food and Drug Administration and the National Cancer Institute expect that all clinical researchers involved in human-subjects research are adequately trained.

"We want to ensure that everyone in the consortium has access to the same basic level of training in these areas," she said.

Dr. Fred Appelbaum, director of the Clinical Research Division and the Seattle Cancer Care Alliance, said that the training modules provide an excellent overview of good clinical practices for anyone who conducts human-subjects research.

"I strongly encourage division members who take part in clinical trials to complete the training modules that are appropriate for their work," he said.

The course, developed by ClinfoSource, is available free of charge to all consortium members from the Center, the University of Washington and Children's Hospital and Regional Medical Center. Modules currently offered include:

For more information, contact Renee LeBlanc, clinical research monitoring coordinator at rleblanc@fhcrc.org or (206) 667-1468.

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