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

3/27/2025 - Emergency Use Access: A Coordinator's Tale

The FDA permits emergency use of an investigational drug for patients in a life-threatening situation when no standard acceptable treatment is available and there isn't enough time to provide the FDA with an expanded access submission and obtain IRB approval. This session will provide guidance on the steps for getting necessary approvals and completing the required follow up information and documents.
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4/24/2025 - Understanding Investigational New Drug (IND) Applications: When You Need One and How to Obtain it

This course will provide a comprehensive overview of Investigational New Drug (IND) applications, which are required by the FDA to authorize the use of experimental drugs in clinical trials. Attendees will learn when an IND is necessary, the key components of a successful application, and the regulatory requirements involved in the submission process. This session will equip participants with the knowledge to navigate the IND process effectively and ensure compliance with FDA regulations.
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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.