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.