Guidelines for Evaluating Clinical Research Training using Competency Assessments [Version 2]

Abstract

Response to reviewers Amendments from Version 1: We thank the reviewers for their valuable comments. We have summarized the changes made to the body of the paper since the initial version below. No changes have been made to the tables and figure included in the initial version. 1. The reviewers stated that the paper would benefit from more definitions and more clarity about CTR training programs and their intended audience. "For an example about definitions, medical education programmes in the UK (undergraduate and postgraduate) are subject to quality control (by the providers) and quality management and quality assurance by regulators. This ensures that the standards for training are being met. I was unclear how this differed from the evaluations that this paper discusses." In the (new) second paragraph of the Introduction, we have provided a description of CTSA programs and what sort of programs are offered for different audiences. Education for CTR is less formal than that of medical education which is designed for clinical practice. We have clarified this point in the third paragraph of the Introduction. 2. The reviewers stated that ad hoc training might be happening within CTR training programs and that evaluators may be fitting competency assessments into this process. We acknowledge that evaluators often have limited control over the content of training, and may find themselves in a situation where they are adapting competency assessments to training programs that have already been implemented. We have added this under the heading "Integrate competency frameworks into evaluation planning". 3. The reviewers stated that some of the guidelines were not specific enough to CTR. We have now provided examples of how these platforms have been used in CTR. We have provided two new citations. These changes are found under the heading "Use technology platforms that best facilitate data collection, analysis and reporting". 4. of some of the terminology used (e.g., evaluations vs. assessments, outcomes). We have clarified the use of these terms throughout the paper. Abstract Effective training programs in clinical and translational research (CTR) are critical to the development of the research workforce. The evolution of global CTR competencies frameworks motivates many CTR institutions to align their training offerings with these professional standards. Guidelines for integrating competency-based frameworks and assessments into rigorous program evaluations are needed in order to promote the quality and impact of these training programs. These guidelines provide practical suggestions for how to ensure that subjective and objective assessments of CTR knowledge and skill can be effectively integrated in the evaluations used to improve these essential training programs. The approach presented here necessarily involves the systematic and deliberate incorporation of these particular types of assessments into comprehensive evaluation plans. While these guidelines are broadly applicable to the work of those charged with developing, administering and evaluating CTR training programs, they have been specifically designed for use by program directors.