Performance Improvement 2008. Could Good Clinical Practice Computer-Based Training Change Researcher Behaviors and Improve Human Subject Safety, Data Integrity and Research Efficiency?


A feasibility study of the Good Clinical Practice (GCP) Computer-Based Training program was conducted to determine whether an outcome evaluation could be designed to provide objective data on whether the training program improved outcomes such as quality of data and patient safety. The GCP training program was implemented to provide a single training e-portal on the scientific and ethical standards of human subject research including NIH, FDA, and international clinical trial policies, guidelines, and regulations. The answers to these studies might provide the basis for the allocation of training resources and the establishment of policies for GCP training for the agency and perhaps other research communities.

The feasibility study showed it would not be possible to attribute directly to the training program improvements in patient safety, data integrity, and research efficiency. A second evaluation was proposed to develop benchmarks for participation rates, user satisfaction and knowledge acquisition. These benchmarks and ongoing evaluation will guide future training program development and quality improvement, allocation of training resources, and GCP training policies. 

Report Title: Feasibility Study of Optimal Approaches for Evaluating the NIAID Good Clinical Practice Computer-Based Training (GCP CBT) Program. Report may be obtained from Federal Contact
Agency Sponsor:
NIH, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID)
Federal Contact:
Nancy L. Jones, Ph.D., 301-451-1399
NOVA Research Company

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"PerformanceImprovement2008.pdf" (pdf, 1.29Mb)

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