Best practices in social and behavioral research: report from the Enhancing Clinical Research Professional's Training and Qualifications project.

Introduction: 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.

Methods: 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.

Education and training of clinical and translational study investigators and research coordinators: A competency-based approach.

Introduction: Training for the clinical research workforce does not sufficiently prepare workers for today's scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals' Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.

Methods: Clinical and Translational Science Awards representatives refined competency statements.

Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.

Introduction: The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.