Clinical Trial Monitoring
Get expert assistance with regulatory compliance from CTSI's clinical research associates (CRAs).
How we can help
- Review study materials (regulatory documents, participant records, drug/device accountability, and consent and eligibility) to assure that the study is conducted, recorded, and reported in compliance with the University of Minnesota policies, FDA regulations, and Good Clinical Practice.
- Ensure the study is conducted in accordance with the protocol and inclusion/exclusion criteria as approved by the IRB.
Setting studies up for success
“
Our [CTSI] monitor is very detail-oriented, which is great, because that's really what you need when somebody is making sure that you're audit-ready,
Rachel Johnson, MA, PhD
Interventional Psychiatry Research Lab
Who we support
- UMN-initiated studies under an IND, IDE, or NSR-IDE by the reviewing IRB.
- Center for Magnetic Resonance Research (CMRR) studies as determined by the CMRR ancillary review.
- Masonic Cancer Center studies as determined by the CPRC ancillary review.
- The UMN site of a multisite trial, if the study would otherwise be eligible for monitoring.
It’s the investigator’s responsibility to request monitoring for their trial(s).
Promoting and facilitating compliance
Templates
Example logs are available upon request.
Standard operating procedures (SOPs)
Cost
Free for eligible University of Minnesota investigators.
Consult with an expert
Sydney Viel
Regulatory Affairs Program Manager
[email protected]
Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)