Study Monitoring

For:

What is this service?

The Study Monitoring team is committed to providing services for all IND/IDE investigator initiated clinical trials as well as support for non-FDA trials as needed. The Food and Drug Administration (FDA) requires the sponsor, including sponsor-investigators, who hold an IND/IDE to ensure proper clinical trial monitoring. Our monitors will follow standard operating procedures and detailed monitoring plans, written in conjunction with the investigator, to provide a tailored approach for monitoring needs.

Monitoring services available include:

  • IND/IDE required monitoring
  • Site initiation, interim, and close-out visits for single and multisite trials
  • Study- and departmental-level targeted reviews

Our monitors provide routine visits to ensure:

  • Appropriate maintenance of essential documentation
  • Informed consent/assent is properly obtained for study subjects
  • Eligibility criteria have been met and documented for each enrolled subject
  • Adherence to the protocol and regulatory requirements
  • Reported study data are verifiable from source documents
  • Storage and accountability of investigational product and biological samples is adequate

Who can use this service?

These services are available to all study teams.

When should I contact MICHR about this service?

We encourage study teams to contact us early in the development of the project.

How much does this service cost?

Study monitoring services are fee-based and are billed at $75 per hour. Special considerations will be made for investigators using MICHR MIAP services. The cost pricing/recharge rates for this and other MICHR services are available here.

 

Study Monitoring

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