As of Sept. 1, 2025, all CWRU research studies that align with the World Health Organization’s definition of a clinical trial must be registered on ClinicalTrials.gov. This policy aligns with national and international standards. It also ensures investigators are not denied publication due to unregistered studies.
The CWRU IRB has expanded its review of protocol submissions. Jennifer Frame, Manager for Regulatory Compliance Monitoring, will conduct ancillary reviews to determine if registration on ClinicalTrials.gov is necessary.
Resources are available on the new Office of Research and Technology Management (ORTM) CWRU ClinicalTrial.gov Support webpage, including:
- Human Research Protection Program (HRPP) Investigator Manual, Chapter 26: Overview of ClinicalTrials.gov Records (PDF)
- CWRU ClinicalTrials.gov Registration Requirements
- CWRU ClinicalTrials.gov FAQs
Direct assistance with questions about ClinicalTrial.gov records or registration procedures is available at irbqip@case.edu.