23 - Enhancing Clinical Research Coordinator Competencies

Background: : Data quality impacts treatment decisions for future patients and is essential for maintaining public trust in research. At a healthcare system, a project to assess current training needs and develop targeted educational strategies to enhance Clinical Research Coordinator (CRC) competencies was executed.

Program

Description: : To achieve the projects objectives, a comprehensive pretest was developed and administered to the CRC staff to identify gaps in CRC knowledge. The pretest consisted of 40 questions across 5 key categories, including Protocol Adherence and Understanding, Adverse Events and Severe Adverse Events, Informed Consent and Regulatory Compliance, CRC Responsibilities, and Research Ethics. The test was administered to 17 CRCs, who used unique 6-digit subject IDs to maintain anonymity. A comprehensive literature review was conducted based on the gaps identified via the pretest, examining the challenges CRCs face and existing educational strategies.

Program

Assessment: : The CRC’s scored lowest on the questions related to Protocol Understanding and Adherence. A literature review on this topic revealed a widespread gap in this area across various research sites. It also explored successful intervention strategies and training programs implemented at other institutions. This analysis informed a comprehensive needs assessment for CRC staff, which included structured training programs, mentorship programs, peer learning opportunities, simulated-based learning, access to online resources and robust feedback mechanisms.

Limitations:: The project could have been enhanced by implementing a more comprehensive pretest that evaluated specific key areas, rather than relying on the broader categories. This would have allowed for a more nuanced understanding of training needs. Also, it was noted that several pretest questions were ambiguous, leading to adjustments in the results to account for this. If these questions have been more clearly formulated, it is possible that the data outcomes would have been different.

Discussion: : This project underscored the critical need for targeted training of CRCs to enhance the quality of clinical trial data and ensure ethical compliance. The findings indicate that improved educational initiatives can lead to better outcomes in both the quality of collected data and adherence to study protocols. Following the design and implementation of the intervention, a post-test will be administered and compared to the pre-test results using a paired t-test to evaluate the effectiveness of the intervention. This model has the potential for easy adoption across various research institutions.