Support for Clinical Trials
MICHR's Clinical Trials Office (CTO) is an excellent resource to assist investigators in planning and carrying out clinical trials, https://www.michr.umich.edu/services/cto. The CTO can also provide study monitoring for clinical trials, especially for those trials that require monitoring for the FDA, such as a study under an investigational new drug application.
Investigational Drug Service (IDS)
The IDS is an invaluable resource for conducting trials that involve FDA regulated drugs or in some cases non-regulated substances. The IDS procures, monitors and dispenses study drugs. Costs involved include study set up, monitoring, purchasing, preparation, and dispensing. To contact IDS, go to TK.
Planning for and Charging Health Care Procedures
Many times, clinical trials will involve health care procedures, such as x-rays, MRIs or lab tests. A billing calendar is required and part of the IRB approval process. To access pricing tools and the MBECT system, go to the Grants Management page http://pmr.med.umich.edu/research/research-operations/grants-management under Billing and Health Care Procedures.
Registering Clinical Trials
All clinical trials are required to be registered on clinicaltrials.gov prior to recruitment of the first subject. To learn more about support and resources at UM, go to TK. To register a trial, go to https://clinicaltrials.gov/.
Writing Standard Operating Procedures (SOPs)
For guidance and templates for creating SOPs, go to https://www.michr.umich.edu/services/projectmanagement/clinicalresearchmanagement/resourcecenter/sops
Michigan IND/IDE Investigator Assistance Program (MIAP)
MICHR's MIAP Program was established to support investigators involved in FDA regulated clinical research. Get in touch with the program early on in the planning of your project, especially for budgetary planning (services are not free or charge!). Go to https://www.michr.umich.edu/services/regulatorysupport/miap to learn more.