Creating a "Good Clinical Practices Inspection" Authentic Online Learning Environment through Educational Design Research.

Abstract

Educational design research (EDR) was applied to address the challenge of providing more public health professionals with opportunities to develop their knowledge and skills related to Good Clinical Practices (GCP) inspections. The conduct of clinical research in accordance with the principles of GCP is necessary to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. The safety and efficacy of pharmaceuticals, medical devices, and other healthcare products depend upon the application of GCP. The World Health Organization has been providing a global face-to-face GCP Inspection course in Indonesia for a decade, but budget constraints only allow this course to be offered once a year to 15 participants. This paper describes how the move from a face-to-face course to an online authentic learning environment was accomplished through EDR and concludes with a discussion of design principles derived from the research. The results of a beta test of the new online course with 12 participants are also described in the paper.