Research Coordinator Enrichment Series Header
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
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1/23/2025 - Guidance on IRB Submissions: Amendments and Continuing Progress Reports (CPR)
An amendment to a research protocol is a formal document outlining changes to an approved study, needing IRB review before implementation. A Continuing Progress Report (CPR) updates the IRB on the study's overall progress and status. This presentation will provide guidance on the necessary information and documentation for submitting amendments or CPRs to the IRB.
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2/27/2025 - Study Closeout Logistics
Study closeout logistics refers to the organized process of concluding a clinical trial in compliance with regulatory, ethical, and contractual requirements. During this session, concise guidance will be provided on when to close a study and what steps need to be taken. We will discuss what procedures can take place after closure and what cannot, as well as rules and regulations that need to be followed before and after closing. This session will focus specifically on investigator-initiated trials.
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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.
View Past Sessions
5/18/23 - Contractual Agreements in Clinical Trials
6/15/23 - Reportable Events UPIRSO, AE, SAE
7/20/23 - Site Selection & Study Start Up
8/17/23 - Source Documents and Case Report Forms
9/21/23 - Clinical Trial Inpatient Enrollment
10/19/23 - Compassionate vs Emergency Use of Investigational Treatments
2/22/24 - Preparing for an FDA Inspection
3/28/24 - Exception From Informed Consent (EFIC)
5/23/24 - Delegation of Authority Log
6/27/24 - Using Epic for Day To Day Conduct of Clinical Research
Contact Us
Please contact us with questions.