UW Medicine’s Office of Clinical Research and Children’s Hospital and Regional Medical Center (CHRMC) have launched a Web-based “Good Clinical Practice” (GCP) training program. The training carries both continuing medical education and continuing nursing education accreditation. It is also continually available to users as a free reference. Users from UW Medicine and affiliated units, including the VA, must have a UW NetID in order to access the program.
The Web site is https://courses.washington.edu/studygcp/
GCP is an international ethical and scientific quality standard for conducting clinical trials that involve human subjects. GCP standards are recognized by the federal Office for Human Research Protections and are included in the U.S. Food and Drug Administration guidance document for clinical trials.
“GCP courses, typically lasting one to three days and located in other cities, are offered by commercial companies. However, time and money for such courses are not widely available to busy clinical research investigators and their staff,” said Dr. Evan Kharasch, assistant dean for clinical research at UW Medicine. “Therefore, we are offering this basic GCP course as a convenient, continuously available tool both for people with hands-on clinical research responsibilities and for people with clinical research oversight responsibilities.”
The Web-based GCP training is different from the NIH-required education on the protection of human research participants, Kharasch noted. Instead, the GCP training program emphasizes the practical roles and responsibilities of the research team, including investigator responsibilities, safety reporting, study-drug accountability, and interactions with study sponsors and regulatory agencies. Also included in the GCP training program are modules about informed consent and ethical considerations in clinical research.
UW Medicine and CHRMC licensed the program content from ClinfoSource, a vendor in Danville, Calif., after jointly evaluating ClinfoSource as the best available Web-based program. The GCP program represents a partnership with ClinfoSource, with UW Medicine and CHRMC providing input and revisions to the vendor’s existing program. The GCP program also represents a partnership with UW Outreach, creators of the Web system to deliver the content.
The Institute of Medicine’s 2003 report, “Responsible Research: A Systems Approach to Protecting Research Participants,” concluded that research investigators and key personnel should be versed in the ethical foundations and regulatory requirements underlying human subjects protections, that GCP training is in the best interests of human subjects, and that such training helps to maintain the public trust in clinical research.
The Web-based GCP program is available at no cost to faculty, matriculated students, trainees, and staff of the UW, Children’s Hospital and Regional Medical Center, Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System.
In addition to UW Medicine and CHRMC, support for the Web-based GCP program is provided in part by the UW’s Office of the Vice Provost for Research and by an NIH Human Subjects Research Enhancements Program Grant.
For more information on the GCP training, call Gigi Streidl at 206-616-8289.