Development, Implementation and AssessMent of Novel Training in Domain-based Competencies (DIAMOND)

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Critical impediments currently exist regarding how clinical trials are conducted which include inconsistent (or absent) training, as well as passive learning techniques used for developing the clinical research workforce. Our group lead efforts to identify clinical research competency domains related to clinical research; however a curriculum mapped to these domains and objective competency based assessments for these domain-specific competencies don’t exist. Therefore there exists a critical need to develop, demonstrate, and publically disseminate competency-based training for clinical research personnel involved in executing clinical trials throughout the CTSA consortium. To do this, we will build upon our efforts to harmonize multiple core clinical research competencies into a set of single, role-based standards (developed in Phase II of the Enhancing Clinical Research Professionals’ Training & Qualification [ECRPTQ] project supported by NCATS) that serve as the framework for developing a competency-based curriculum, demonstrating its use, and disseminating this training across CTSA hubs. Our proposal entitled, Development, Implementation and AssessMent Of Novel Training in Domain-based Competencies (DIAMOND), has the objective to develop an online educational portal (DIAMOND portal) for competency-based educational offerings and assessments and to demonstrate integration of this curriculum into CTSA clinical trial education programs at DIAMOND hubs and partner sites in ways that promote the more effective, efficient, and safe execution of clinical trials; allowing for dissemination to a broader audience. Our rationale is that use of competency-based educational offerings and validated observational assessment rubrics will ensure consistency in how clinical research personnel are trained to standards that optimize the quality and efficiency of clinical trial execution. This project addresses a significant issue in clinical trials research as scientific ‘answers’ derived from interventional clinical trials are only as good as the quality with which the study is executed and are dependent on a highly competent study team to execute the research procedures. Therefore, translation of novel drugs, devices, and interventions into improved human health requires a well-prepared, competent workforce of clinical research professionals who effectively and efficiently conduct trials. The innovative development and demonstration of mapped competency based assessments through the DIAMOND portal will then be freely disseminated to all CTSA hubs and beyond, which we hypothesize, will eventually improve clinical trials execution, potentially resulting in accelerated health outcomes. Ultimately, DIAMOND will facilitate improved knowledge and capacity of the clinical research workforce within the CTSA consortium and strengthen clinical trials research quality by enabling NCATS’ vision for an efficient and effective clinical trials network between the CTSA hubs and overall consortium.