Best Practices in Social and Behavioral Research: A multisite pilot evaluation of the good clinical practice online training course

Abstract

IntroductionThe Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course.MethodsParticipants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted.ResultsParticipants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later.DiscussionThe course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

Mobilizing cross-disciplinary teams to advance translational research using design thinking methods

“…Indeed, Research Jams provided a unique opportunity for faculty champions to identify collaborators who have the potential to be most invested in the work before it begins. Future evaluation of Research Jams will seek to understand if and how participants' ways of working change over time using open-ended questions, such as described in Murphy et al [32], which are intended to identify a broad array of outcomes. We will map survey responses to the transtheoretical change model [33], which posits that changes in behavior progress through a series of stages, including contemplation, preparation, and action.…”

Creating and testing a GCP game in an asynchronous course environment: The game and future plans

“…The requirement for documentation of GCP training has been a well-established standard to ensure improved quality, safety, and compliance in clinical research. With the revision of the ICH guidelines to include E6 R2 (Step 4), including the emphasis on risk-based approaches for study development, monitoring, and quality improvement, continued calls for GCP training have been issued, especially to address the needs in Social and Behavioral clinical research and in workforce development [17][18][19]. We have described an innovative approach to GCP training using the Kaizen-Education gamification platform.…”

Updating and evaluating a research best practices training course for social and behavioral research professionals

“…NIH-funded researchers involved in clinical trials to complete GCP training and identified various training opportunities for the workforce to meet the new requirement [ 15 ]. The original Social and Behavioral Research Best Practices course was developed in 2016 by a team at the University of Michigan (U-M) to educate clinical and translational researchers to apply GCP principles to social and behavioral research [ 16 ]. This training course, which took a median of 3.2 hours to complete, contained modules on key topics including research protocols, participant recruitment and retention, informed consent communication, confidentiality and privacy, participant safety and adverse event reporting, quality control and assurance, and research misconduct.…”

“…This training course, which took a median of 3.2 hours to complete, contained modules on key topics including research protocols, participant recruitment and retention, informed consent communication, confidentiality and privacy, participant safety and adverse event reporting, quality control and assurance, and research misconduct. A description of the development and evaluation of the original course is available elsewhere [ 16 ]. The NIH Office of Behavioral and Social Sciences Research included this course in online training resources offered to the health research workforce [ 17 ].…”