Course provides lessons in research quality control

General Article
August 21, 2003

Web-based training modules offer free lessons in safe and ethical practices for researchers in clinical trials

By BARBARA BERG

A new Web-based training course on good clinical practices is now available for any member of the Fred Hutchinson/University of Washington Cancer Consortium involved in human-subjects research. The six-module course is offered through the Clinical Trials Support Office, one of the eight resources housed within the Research Trials Office.

The course provides clinical researchers with a foundation in good clinical practices, the international standards developed 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, Clinical Research Manager, said that while the course is not required, federal oversight agencies including the 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. Access to the modules was recently made available to Fred Hutchinson researchers who are principal investigators of clinical trials and clinical trials coordinators. In the next few weeks, researchers in the Public Health Sciences Division and consortium members outside Fred Hutchinson will receive an e-mail that describes how to access the secure server that houses the training modules.

Modules currently offered include:

• Introduction to Clinical Research
• Principles of Good Clinical Practice
• Investigator Responsibilities
• Ethical Considerations in Clinical Research
• Case Report Form Design
• FDA Audits

Over the next several months, course content will be customized for consortium research and additional modules will be added.

For more information, contact Linda Bakke at lbakke@fhcrc.org or 206-667-2870, or Lynda Spates, program assistant, at lspates@fhcrc.org or 206-667-1914.

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