Research Coordinator Enrichment Series

The CTSI Academy is offering an education series addressing day-to-day components of clinical research conduct. This series will have a strong emphasis on the practical conduct of clinical research at MCW and its partner institutions.

Upcoming Sessions

May 28, 12:00 - 1:00 p.m. - Understanding IDE Requirements: From Exemptions to Risk Assessment

This session explains how FDA Investigational Device Exemption (IDE) requirements apply to clinical investigations involving medical devices, from determining whether a study is a device study to identifying applicable exemptions. The presentation will walk through IDE exemption criteria, non-significant versus significant risk determinations, and the roles of sponsors, IRBs, and FDA in risk assessment and oversight. Attendees will gain a practical framework for evaluating IDE applicability, conducting, and documenting study risk assessments, and navigating abbreviated versus full IDE requirements with confidence.
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June 25, 12:00 - 1:00 p.m. - When Things Go Wrong in Clinical Research: Managing Errors and Staying Compliant

This session focuses on recognizing and managing issues that arise during study conduct. Participants will learn practical approaches to handling challenges, ensuring accurate documentation, and meeting reporting requirements while maintaining compliance and participant safety.
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Our aim is to equip research staff with guidance on the common challenges faced by research teams during clinical studies. Presenters will offer valuable strategies to ensure the safe, efficient, ethical, and compliant conduct of research. At the conclusion of each session, participants will have the opportunity to engage in an open discussion with our experts by bringing their questions. This program will feature experts from the MCW Clinical Trials Office, as well as various research departments across MCW.

Objectives

This series is designed to help participants:

Gain in-depth knowledge of best practices through a variety of focused topics
Build confidence in the conduct of clinical research
Apply the knowledge gained into day-to-day practice
Bring issues encountered during conduct of research for an open discussion with experts in the area
Connect and communicate with experts and use those connections to problem solve issues you encounter in your daily activities.

Intended Audience

Any staff, faculty member, resident or fellow involved in conduct of clinical research.
There are no pre-requisites for this course.

Notes

Sessions will be virtual and in-person from 12-1 p.m. Participants are welcome to bring lunch.

A completion certificate is available upon request for participants who attend at least 80% of the course. Participants may use contact hours for maintaining ACRP and SOCRA certification.