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This article discusses the process of defining competencies and development
of a best practices training course for investigators and clinical research
coordinators who conduct social and behavioral research.
The first project phase established recommendations for training in Good
Clinical Practice (GCP) and was done in conjunction with representatives
from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in
behavioral clinical trials and differences in regulation of behavioral
trials compared with clinical trials involving drugs, devices, or biologics
necessitated a separate Social and Behavioral Work Group. This group worked
with CTSA representatives to tailor competencies and fundamental GCP
principles into best practices for social and behavioral research.
Although concepts underlying GCP were deemed similar across all clinical
trials, not all areas were equally applicable and the ways in which GCP
would be enacted differ for behavioral trials. It was determined that
suitable training in best practices for social and behavioral research was
Based on the training need, an e-learning course for best practices is
available to all CTSA sites. Each institution is able to track outcomes for
its employees to help achieve standardized competency-based best practices
for social and behavioral investigators and staff.
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