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 sponsors (including investigator sponsors) 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.
The FDA has recently distributed draft Guidance on Risk-Based Monitoring. Our monitors are using this new guidance to ensure that monitoring is focused on areas where the investigator is potentially at the highest risk.
We ensure not only that the IRB-approved protocol is being followed, but also that your site documentation tells the story of the work you have put into the trial. Study-specific site monitoring services available include:
- IND/IDE-required monitoring services
- Site initiation, interim, close-out visits
- Pre-/post-OHRCR audit reviews
- NIH/DoD preparation visits
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 an hourly rate.