163 Development and implementation of training in best practices for study documentation: A new resource for the research workforce

Objectives/Goals: To develop and implement a new course to fill an identified gap in the present IU School of Medicine Clinical Research Staff Education program, enhance data accuracy, and minimize audit findings. The goal was to provide a robust and thorough training on study orientation, source documentation, and adhering to ALCOA+ principles to clinical research staff. Methods/Study Population: A 90-minute presentation titled Best Practices for Study Documentation, or Level 1.5 because it fills the gap between the currently offered Level 1 and 2 courses, was developed by monitoring team members with input from the Director of Research Staff Education. A pilot session was presented to senior research staff for feedback prior to launch. The 90-minute presentation was designed with interactive polls to assess attendees’ research and documentation experience at the start and to maintain engagement throughout the session. Attendees receive a post-course evaluation survey along with a certificate of attendance. The course is offered every two months. Completion of Level 1 training is a prerequisite and aimed at those who are three to six months of starting in research at Indiana University School of Medicine. Results/Anticipated Results: Results from the post-course evaluation survey described Best Practices in Study Documentation as engaging, informative, and valuable for new and experienced research staff. Many learners reported increased confidence, improved understanding of documentation and regulatory requirements, greater awareness of the tools and resources available and appreciation for real-world examples from the instructors. While attendees valued the presentation’s clarity and interactive polls, they suggested leaving more time for questions, supporting reference materials, and an ability to watch a recording of the session. Overall, feedback has been highly positive, with learners emphasizing the relevance, practicality, and effectiveness of the presentation. Discussion/Significance of Impact: Best Practices for Study Documentation has been delivered nine times to 235 attendees since its inception in Jun 2024, 63% of learners report they have < 2 years’ research experience. Evaluation feedback is positive; however, no quantitative method has been identified to measure improvement in documentation quality or reduction in audit findings.