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

  • Susan L. Murphy (a1) (a2), Christine Byks-Jazayeri (a1), Nancy Calvin-Naylor (a3), Vic Divecha (a1), Elizabeth Anderson (a1), Brenda Eakin (a1), Alecia Fair (a4) and Laura Denton (a5)...

Abstract

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. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research.

Results

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 lacking.

Discussion

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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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Pressmust be obtained for commercial re-use or in order to create a derivative work.

Corresponding author

*Address for correspondence: S. L. Murphy, Sc.D., O.T.R., Associate Professor, Department of Physical Medicine and Rehabilitation, University of Michigan, 24 Frank Lloyd Wright Drive, Lobby M, Suite 3100, Ann Arbor, MI 48105, USA. (Email: sumurphy@med.umich.edu)

References

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1. Notice of Revised NIH Definition of “Clinical Trial” [Internet] [cited March 23, 2016]. (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).
2. Arango, J, et al. Good clinical practice training: identifying key elements and strategies for increasing training efficiency. Therapeutic Innovation & Regulatory Science 2016; 50: 480486.
3. Minimum Criteria for ICH E6 GCP Investigator Site Personnel Training. [Internet] [Cited March 3, 2016]. (http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-GCP-Training-Minimum-Criteria-in-Operating-Principles_0.pdf).
4. Sonstein, SA, et al. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 2014; 28: 1723.
5. Calvin-Naylor, NA, et al. Education and training of clinical and translational study investigators and research coordinators: A competency-based approach. Journal of Clinical and Translational Science 2017; doi:10.1017/cts.2016.2.
6. Good Clinical Practice for Social and Behavioral Research – eLearning Course. Office of Behavioral and Social Sciences Research. [Internet] [cited December 20, 2016]. (https://obssr.od.nih.gov/training/web-based-learning/good-clinical-practice-for-social-and-behavioral-research-elearning-course/).

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