Office of Sponsored Programs
The Ohio State University

Clinical Trials Workflow

Establishing a clinical trial at Ohio State requires the coordination of the efforts of several offices, including the PI’s office, the Clinical Trials Management Office (CTMO) in the College of Medicine or the Clinical Trials Office (CTO) in the Comprehensive Cancer Center, the Office of Sponsored Programs, the Ohio State University Wexner Medical CenterResearch Billing Office, and the Office of Responsible Research Practices (ORRP). Each party’s role is described in the workflow diagram below, in which the term PI refers to the PI and/or the CMTO/CTO.

clinical trials flowchart

When a PI receives a request from a sponsor to participate a clinical trial, 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 should contact the contracts team in the Office of Innovation and Economic Development (OIED). Factors that the PI should consider in determining whether a trial can be successfully conducted at Ohio State include subject population, staffing, financial feasibility, 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 Ohio State:

  • Send the contract, protocol and sponsor contact information to the Sponsored Program Officer.
  • Submit the protocol package through Buck-IRB.
  • If the PI does not negotiate the budget, send the protocol and budget materials to the CTMO/CTO or 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 Ohio State 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, and all the following tasks must be complete before the contract can be signed by the Office of Sponsored Programs.

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 is completed 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 CTMO/CTO 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 explanatory document to assist PIs with this task. The internal budget is then compared to the budget offered by the sponsor. The PI or budget manager negotiates the budget directly with the sponsor. After the budget is negotiated, the final budget is sent to the Sponsored Program Officer for inclusion in the contract.

IRB

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

Office of Sponsored Programs

The Sponsored Program Officer reviews the contract, protocol, informed consent form 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 Sponsored Program Officer forwards the contract to the PI for review and signature. The PI returns the contract to the Sponsored Program Officer.

The Office of Sponsored Programs will sign the contract after all the following conditions are met:

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

After the fully signed contract is returned to OSP, a grant number is assigned and sent to the PI and a copy of the agreement is uploaded to the PI Portal. The PI submits the OSP grant number to the Research Billing Office to obtain a research billing number for hospital-billed services.