Processing Checkpoints

During the initial consultation with the Trinity Health Office of Research & Innovation – West Michigan staff, the following topics will be addressed, whether for an investigator initiated study or sponsored clinical trial:

Investigator Initiated Research

1. HR clearance
2. Study design development
3. Feasibility/proposal/budget
4. Required agreements
5. Privacy review
6. Data security analysis
7. After all other requirements have been fulfilled, you will be given permission to submit to the Institutional Review Board (IRB)

Sponsored Clinical Trial

1. Feasibility/proposal/budget
2. Confidentiality Disclosure Agreement (CDA) & Clincal Trial Agreement (CTA)
3. Privacy review
4. Data security analysis
5. After all other requirements have been fulfilled, you will be given permission to submit to the Institutional Review Board (IRB)