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.