Site Inspections
In order to ensure operational compliance with research standards, all research conducted through Trinity Health Michigan remain answerable to and is subject to inspection by the appropriate authorities. These authoritative groups include, but are not limited to, the following:
- Trinity Health Office of Research & Innovation – West Michigan
- Trinity Health Regional Institutional Review Board
- Other designated IRB
- FDA (US Food and Drug Administration)
- OHRP (Office for Human Research Protections)
- Privacy Board
- Research Sponsor
Depending on the project's design, inspection of any component of the research project may occur, including, but not limited to, the following:
- Study specific records
- Study Equipment
- Processes (such as the Informed Consent process)
- Policies
- Physical location
Non-compliance with any federal regulations, institutional or investigative site policies may result in study closure, data considered non-useable for research purposes or other implications under local, state and federal laws.
For further guidance or additional questions, please submit a consultation request.
Helpful Links
Institutional Review Board SOPs: