What is CTME?
Clinical Trial Management Ecosystem Maturity Project
- A working group created to discuss all aspects of clinical research operations
- Team of 36 people from 17 different institutions around North America
- Model developed by a multi-instiutional CTSA team
- Eleven categories with detailed descriptions across five levels of maturity
- The University of Iowa CTME assessment team rated and created plan for improving our maturity level FY 23 & 24
- The goals of this assessment include:
- Improving the understanding of technicals and organizational issues related to the Clinical Trial Management Ecosystem (CTME) project.
- Establishing consortium wide benchmarking
- Enabling leadership to identify and remove barriers related to the CTME
Maturity Model Criteria
- Study Management
- Regulatory and Audit Management
- System Integration and Interfaces
- Financial Management
- Investigational Product Management
- Subject Identification and Recruitment
- Staff Training and Personnel Management
- Subject Management
- Data Capture and CRF
- Reporting Analytics and Dashboard
- Organizational Maturity and Culture
Publications
- Subramain M, Sprenger K, O’Connell-Moore D, Jones-Bitterman C, Knosp BM. 532 Application of the CTME Maturity Model in a CTSA Hub: An Initiative to Improve Clinical Research Operations. Journal of Clinical and Translational Science. 2024;8(s1):158-158. Doi:10.1017/cts.2024.454
Contact
Maran Subramain, Ph.D.
- Assistant Director for Evaluation
- Institute for Clinical and Translational Science
- University of Iowa
- 200 Hawkins Drive/C44-C GH
- Iowa City, IA 52242
- 319-384-8319
The CTME Team
The CTME Team
Faculty Sponsor
- John Buatti, MD
- Professor of Radiation Oncology
Team Members
Human Subjects Office
- Michele Countryman
- Director, Human Research Protection Program
- Debra O'Connell-Moore
- Assistant Director of Education & Compliance
Grant Accounting Office
- Maria Soliman
- Director, Grant Accounting
Holden Comprehensive Cancer Center
- Cena Jones-Bitterman
- Assistant Director, Compliance & Informatics
Institute for Clinical and Translational Science
- Sandra Ahrendsen
- Senior Business Analyst, Informatics
- Kim Sprenger
- Assistant Director of Clinical Research Services
- Maran Subramain
- Assistant Director for Evaluation
- Kristy Mahan
- Administrative Services Coordinator, Clinical Research Services
- Laura Jacobus
- Director of Operations and Research Administration
More information re: the CTSA initiative that has been sunset - though we continue local efforts across the house at UI