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.
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ResearchCoordinatorEnrichment_Intro Component

Upcoming Sessions

11/21/2024 - Expanded Access

The FDA has a mechanism for use of unapproved drugs and biologics outside of a clinical trial for patients with serious diseases or conditions when there is no satisfactory alternative therapy to treat the patient’s disease or condition. While not a clinical trial, the FDA still requires that the physician submit an IND to the FDA to allow the use of the product. IRB review and approval is also required as part of FDA ‘s permission to use the drug process. This presentation will provide circumstances where individual patient or intermediate group expanded access can be requested as well as steps to obtain FDA approval specifically for the patient / small group, and work flows necessary to obtain IRB approval.
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Our goal is to provide research staff with guidance on specific situations encountered by research teams on a routine basis while conducting clinical research. Presenters will share tips and tools for safe, efficient, ethical, and compliant conduct of research. At the end of each session, participants are invited to bring their questions for an open discussion with our experts. This program will feature experts from the MCW Clinical Trials Office and from various other 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.