Clinical Study/Clinical Trial Agreements
Efficient study start-up of industry-supported clinical research requires attention to multiple processes concurrently. This includes:
- IRB (Human Subjects Committee) review and approval
- Review and Approval of other committees as required by protocol and/or institutional policy (IBC, radiation safety and ESCRO)
- Clinical Study Contract review, negotiation and full execution in OVPR - Clinical Research
- Proper account set up in Financial Services at UMass and, if hospital charges are required, set up of a UMass Memorial billing number known as "G98" #
The attached forms and slide deck explain the layers of process and shared responsibilities of the investigator, study staff, OVPR Clinical Research staff and administration to ensure thorough review of contracts and appropriate budget approval.