Acute care research competencies for clinical research professionals

Introduction:Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings.Methods:Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom’s Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics.Results:There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success.Conclusion:The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.

Competency to Stand Trial

A core principle of modern-day law is that all defendants maintain the right to a fair trial. A defendant must be able to factually and rationally understand and participate in a court process, the ability to do so deems the defendant competent. Competency is relevant through all stages of the criminal justice process from arrest through sentencing. This article describes research and scholarship related to competency to stand trial. Competency to stand trial is a doctrine of jurisprudence that requires criminal proceedings to be postponed if a defendant is unable to meaningfully participate in his or her defense on account of a mental disease or defect. The US law regarding trial competency was established in the 1960 US Supreme Court Case Dusky v. United States (cited under Origins of Competency to Stand Trial and Key Legal Cases), and currently all states use some variant of the Dusky standard, with the exact definition varying by jurisdiction. Competency evaluations are essential to ensure the protection of a defendant’s due process rights guaranteed by the US Constitution. Approximately sixty thousand defendants are evaluated for trial competency annually, making this the most common forensic issue evaluated. Ultimately, an individual’s competency is a legal issue and does not have a distinct or easily identifiable psychological correlate. However, judges’ rulings closely follow mental health professionals’ recommendations most of the time, highlighting the importance of forensic mental health evaluators understanding the reason for the referral, the concerns surrounding competency, and the specific demands of the case. Issues of competency may be raised at any point during the proceedings, and if a bona fide doubt exists regarding competency, the issue must be formally considered: thus requiring a forensic evaluation. A defendant’s competency is assessed based on his or her present ability to understand court proceedings, make educated legal decisions, conduct oneself in a manner appropriate for court, and contribute to the development and execution of one’s legal defense. Forensic evaluators are tasked with describing the degree of congruence or incongruence between the relevant jurisdictional competency standard and the defendant’s current abilities. To complete this task, forensic evaluators must maintain a combination of advanced clinical skills coupled with knowledge about the legal system, competency standards, and the proper interpretation of the data collected for the evaluation.

Clinical research coordinators’ instructional preferences for competency content delivery

IntroductionA lack of standardized clinical research coordinator (CRC) training programs requires determining appropriate approaches for content delivery. The purpose of this study was to assess CRCs preferred training delivery methods related to the 8 designated Joint Task Force Clinical Trial Competency domains.MethodsRepeated measures analysis of variance and split-plot analysis of variance were adopted to compare the group means among 5 training delivery methods by 8 competency content domains and to examine whether demographic variables caused different preference patterns on the training delivery methods.ResultsParticipants reported a preference for online video; mentoring/coaching was the least preferred. Significant training delivery method preferences were reported for 3 content domains: participant safety considerations, medicines development and regulation, and clinical trials operations.DiscussionObserved statistical differences in the training delivery methods by the content domains provides guidance for program development. Ensuring that standardized educational training is aligned with the needs of adult learners may help ensure that CRCs are appropriately prepared for the workforce.

2479 Acute care research competencies for clinical research professionals: A practitioner inquiry approach and assessment

OBJECTIVES/SPECIFIC AIMS: Acute care research is a unique area of clinical research that demands specialized skills, knowledge, and talents from empathetic professionals working in the field. Building off existing competencies for clinical research professionals, the Cincinnati Acute Care Research Council (ACRC) developed additional areas of competency for professionals working in the acute care research discipline. METHODS/STUDY POPULATION: Qualitative data obtained from job shadowing, clinical observations, and interviews were analyzed to understand the educational needs and desires of the acute care research workforce. We then utilized Bloom’s Taxonomy to build acute care research competencies that are measurable for job performance and build off of foundational clinical research professionals’ domains and competencies developed by the Joint Task Force of Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: Results suggest 35 special interest competencies for acute care clinical research professionals under 8 common domains set by the Joint Task Force of Clinical Trial Competency. Additionally an approved ACRC tactic, from actionable learnings through community assessments throughout 2017, is the creation of a Task Force made up of acute care research Principal Investigators and Clinical Research Directors to focus on the identified training and professional development obstacles in the clinical research enterprise. DISCUSSION/SIGNIFICANCE OF IMPACT: The competencies developed for acute care research should serve as guidelines for training a workforce prepared for the challenges of conducting research with each acute audience, as its own vulnerable population. These competencies will guide development of a multi-pronged program of professional development that will include new hire onboarding, new hire on-job training, and ongoing on-job training.

2007 The clinical research operations program: Educating clinical research staff

OBJECTIVES/SPECIFIC AIMS: The Clinical Research Operations Program is a free educational program designed to educate clinical research personnel on the conduct of clinical research (CR). The participant completes 16 required core sessions (24 h), 4 elective sessions (4 h), and passes the final exam to receive a certification in CR operations at Stanford. Sessions focus on the 9 domains of CR (established by the Joint Task Force for Clinical Trial Competency), such as Ethical & Participant Safety Considerations, Clinical Study Operations, & Data Management/Informatics. METHODS/STUDY POPULATION: Sessions are taught by volunteer lecturers. Participants may also attend the sessions without pursuing the certification. The program objective is to provide easy-access education in CR in order to increase regulatory compliance, staff retention, and improve CR at Stanford. The program targets CR coordinators, however, staff, postdocs, fellows, and faculty also participate. RESULTS/ANTICIPATED RESULTS: Since the program’s launch in January 2017, 119 individuals have enrolled in the certification program. The most represented group is the Department of Medicine. Sessions consistently reach their maximum with a waiting list. Each core session requires that the participant complete an evaluation (Likert scale, 1–5) of the registration process (4.5/5), the class environment (4.6/5), the presented content (4.5/5), and the instructor (4.6/5). Data from these evaluations are positive to date and is used to continually refine the program. DISCUSSION/SIGNIFICANCE OF IMPACT: N/A.