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

Abstract

IntroductionThe 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.MethodsIn 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.ResultsThis paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.ConclusionsWe anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

“…The findings from our study are in line with recommendations released by the CTSA Consortium Enhancing Clinical Research Professionals' Training and Qualification (ECRPTQ) project calling for GCP trainings that are reciprocally accepted by sponsors in an effort to reduce redundant training requests [2]. The CTSA Consortium accepted the industry standard of having GCP refresher trainings every 3…”

“…years, but further research should be conducted to better ascertain the right training frequency to simultaneously reduce redundancy and protect patient safety [2].…”

“…Concerns have been raised over the current structure and delivery of GCP training to prepare clinical investigators and their delegates to conduct registrational clinical trials [1,2]. GCP training has been described as timeconsuming [3], emphasizing trial activities unrelated to research validity [4] and providing only the minimum of what is needed in the quality conduct of clinical trials [1]; redundant [1]; lacking specificity about the definition of site quality or clinical investigators' perspectives on site [5]; and having monitoring standards that vary widely across research studies and sites [6,7].…”

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.…”

Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study

“…A growing number of professional societies, funding agencies, and clinical trial sponsors now offer GCP training programs [4]. In 2014 and 2017, expert consensus committees adopted eight core competencies for GCP training programs, each with specific sub-competencies [4][5][6]. However, GCP training programs are currently highly variable in format (including diverse online and face-to-face formats), duration (from 45 minutes to lengthy certification programs), and scope of content.…”