Proposal Development

Industry-Sponsored Clinical Trials: Checklist

Bringing an industry-sponsored clinical trial to Ohio State requires the coordination of the efforts of several offices, including the PI’s office, the Research Foundation, the OSU Hospital’s Research Billing Office, and the IRB. Each party’s role is described below, as is the timeline for completion of each party’s responsibilities.

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When a PI receives a request from an industry sponsor to participate in one of its clinical trials, s/he must evaluate the materials provided by the sponsor to determine if it is feasible to perform the work at Ohio State. If the sponsor requires that a confidentiality or non-disclosure agreement be in place before it will send the materials to the PI, the PI must work with the Technology Licensing & Commercialization office (click here for the form for to send agreements to TLC). Factors that the PI should consider in determining whether a trial can be successfully conducted at OSU include subject population, staffing, and academic significance.

If a PI decides to proceed with a trial, the PI needs to inform the other parties responsible for bringing the study to OSU:

Send the contract, protocol, fee agreement, and sponsor contact information to the Research Foundation sponsored program officer (SPO) in charge of negotiating the contract.
Submit the protocol package to the IRB.
If the PI does not negotiate the budget, send the protocol and budget materials to the budget manager in the department.
Submit the ePA-005 to obtain institutional approval to proceed with the trial.
If not already complete, submit the OSU conflict of interest disclosure to the Office of Research Compliance (this disclosure must be submitted annually and updated as necessary).

The major tasks and the parties responsible for each are outlined below. In most cases, these tasks can be completed concurrently. Please note that all the following tasks must be complete before the contract can be signed by the Research Foundation.

Internal Approvals

The ePA-005 must be signed electronically by the PI and all co-investigators named in the form. It is also signed by the departments and colleges involved. The form iscompleted online by the PI or a delegate and routed electronically.

All investigators named on the ePA-005 must have an up-to-date conflict of interest disclosure on file with the Office of Research Compliance.

The PI also must ensure that s/he has no outstanding effort certifications.

Budgeting

The PI (or department budget manager, if applicable) develops an internal budget for the trial based on the procedures outlined in the protocol. The College of Medicine has developed an Excel spreadsheet template and an accompanying explanatory document to assist PIs with this task. Costs for hospital-billed services are provided by the Hospital's Research Billing Office via their ROWA online application, which requires access to the OSU Medical Center's intranet, OneSource. PIs without access to OneSource may call the Research Billing Office for rates at 293-2103. It may also be necessary to work with the Hospital's Research Billing Office to determine rates for unique services or device purchase agreements. The internal budget is then compared to the budget offered by the sponsor. The PI or budget manager negotiates the budget with the sponsor, with help from the Research Foundation SPO, as necessary. After the budget is negotiated, the final budget is sent to the SPO for inclusion in the contract.

As the PI develops the internal budget, s/he must usually complete the Medicare Assurance Document and submit it to the Research Billing Office. See the Research Billing Office’s website to determine whether a particular trial requires this document.

IRB

After the IRB approves the protocol, the PI should send a copy of the approved informed consent form to the SPO. The SPO will ensure that the terms of the contract are congruent with the approved informed consent form.

Research Foundation

The SPO reviews the contract, protocol, informed consent form and fee agreement and negotiates acceptable terms. The PI and department may be asked to approve unusual terms, such as publication restrictions. After the contract and budget are finalized, the SPO forwards the contract to the PI for review and signature. The PI returns the contract to the SPO.

The Research Foundation will sign the contract after the following conditions are met:

Protocol and informed consent form are approved by the IRB
ePA-005 is fully signed
Medicare Assurance Document sent to Research Billing Office, if required
Conflict of interest disclosure complete
Contract fully negotiated
Effort certifications are up-to-date

After the fully signed contract is returned to the Research Foundation, a project number is assigned and sent to the PI along with a copy of the contract. The PI submits the RF project number to the Research Billing Office to obtain a research billing number for hospital-billed services.