Clinical Trial Monitoring

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Get expert assistance with regulatory compliance from CTSI's clinical research associates (CRAs).
 

Request support

Off campus? Connect to VPN before requesting support.

How we can help

  • Review study materials (documents, records, drug/device accountability, case report forms, etc.) to assure that the study is conducted, recorded, and reported in compliance with University of Minnesota policy, 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. 

It’s the investigator’s responsibility to request monitoring for their trial(s). 

Who we support

  • UMN-initiated studies under an IND or IDE, or designated 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.
  • All Department of Psychiatry studies, regardless of design.

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Not eligible for CTSI monitoring support?

Not eligible for CTSI monitoring support?

Consider these alternatives:

  • Reviewing your own safety data and overall data integrity when deemed appropriate by the UMN IRB.
  • Engaging the services of a Clinical Research Organization (CRO) when required by the UMN IRB.

Promoting and facilitating compliance with Good Clinical Practice

Cost

Free for eligible University of Minnesota investigators.

Consult with an expert

Sydney Viel
Regulatory Specialist Manager
[email protected]

Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)