91探花Medicine鈥檚 Office of Clinical Research and Children鈥檚 Hospital and Regional Medical Center (CHRMC) have launched a Web-based 鈥淕ood Clinical Practice鈥� (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 91探花Medicine and affiliated units, including the VA, must have a 91探花NetID in order to access the program.
The Web site is
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.
鈥淕CP 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,鈥� said Dr. Evan Kharasch, assistant dean for clinical research at 91探花Medicine. 鈥淭herefore, 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.鈥�
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.
91探花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 91探花Medicine and CHRMC providing input and revisions to the vendor鈥檚 existing program. The GCP program also represents a partnership with 91探花Outreach, creators of the Web system to deliver the content.
The Institute of Medicine鈥檚 2003 report, 鈥淩esponsible Research: A Systems Approach to Protecting Research Participants,鈥� 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鈥檚 Hospital and Regional Medical Center, Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System.
In addition to 91探花Medicine and CHRMC, support for the Web-based GCP program is provided in part by the UW鈥檚 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.