Proposal Development
Industry-Sponsored Clinical Trials: Checklist
| What the PI Does | What OBIC Does |
| Contact OBIC as soon as participation in a clinical study appears likely, e.g., when protocol and/or confidentiality agreement are received. Send OBIC a brief summary of the study and any contract related materials the sponsor has provided. | Contacts the sponsor to introduce the office as point of contact for contracting matters, and to begin discussing contracting issues. |
| Prepare and submit application to Institutional Review Board (IRB). | Reviews materials, obtains any additional information required, and works with sponsor to develop an acceptable agreement and payment terms. |
| Develop budget, with assistance from OBIC. | Keeps the PI informed of and involved in negotiations. |
| IRB approves protocol. (IRB review process should run concurrently with subsequent steps.) | Receives agreement from sponsor, sends to PI for review and approval, then signs agreement and sends it to sponsor for signature |
| Submit proposal package to OBIC: Authorization to Seek Off-Campus Funds Form(ePA-005) signed by PI, chair and dean; Conflict of Interest screening form, if not already on file; budget; protocol; company agreement, if provided; any correspondence with sponsor. | Sponsor signs agreement, returns it to OBIC, and may send first payment. |
| Inform the sponsor and OBIC when IRB approval has been granted. | OBIC assigns account number for the project after ensuring that all necessary approvals are in place. |
