The Department of Neurological Surgery’s Office of Clinical Research assists investigators who are seeking research support to lay the foundation for a clinical trial. Our team can assist with:
- Protocol development
- FDA IND/IDE submissions
- IRB submissions
- Budget development
- Protocol implementation
- Contract assistance
- Data entry
- Monitoring visits
- Internal auditing
- Feasibility of both nontherapeutic and therapeutic intervention
- HUD therapeutic intervention
- Nontherapeutic intervention
- Retrospective chart review
- Therapeutic intervention
- Tissue acquisition
Trial RecruitmentWe can review Neurological Surgery clinics and surgery schedules for patients who might be a good candidate for an identified IRB-approved neurosurgery trial. If we identify a patient of yours, we will share that information with you so that you can discuss the possibility of enrollment with your patient during the appointment. If your patient indicates an interest, our office can assist in the enrollment process by:
- Assessing his or her eligibility.
- Obtaining informed consent.
- Scheduling the patient for any research-only procedures. If a procedure is determined to be for research purposes only, that procedure cannot be done prior to the study consent form being signed.
- Reviewing any eligibility-dependent research-only procedure results.
- Registering the patient for the study.
- Recording all patients on a screening log whether they are enrolled in the study or not. If a patient is not enrolled, providing the reason why he or she was not.
Opening a StudySo you have a new study you just wrote or you have been contacted by an industry sponsor or another institution about participating in their study. What happens next? All you need to do is contact the clinical research coordinator who works on your studies.
Here is an overview of the steps involved to opening a study:
- Our research staff completes a site survey for industry and some multi-institutional studies.
- An agreement (CDA/NDA) between the sponsor and the OSU Technology Commercialization Office (TCO) is negotiated for industry and some multi-institutional studies.
- A Clinical Trials Agreement (CTA or contract) between the sponsor and the OSU Office of Sponsored Programs (OSP) is negotiated for industry and some multi-institutional studies. (This can be done concurrently with the Institutional Review Board [IRB] review process.)
- Prospective studies are entered into the Research Billing Office system for IHIS uploading and research billing account establishment (as necessary).
- Our research staff works with the sponsor/lead site to negotiate a clinical trials budget for industry and some multi-institutional studies. (This can be done concurrently with the IRB review process.)
- All cancer studies must be submitted to the Clinical Scientific Review Committee for review and approval prior to IRB submission.
- Protocol submission (e.g., application, consents, data capture forms) is prepared and submitted by the research staff and PI to OSU IRB/Western Institutional Review Board (IRB/WIRB). The research staff strives to submit new projects to the IRB within four weeks of receipt of final protocol.
For WIRB-reviewed protocols (industry-sponsored): Submission is sent to OSU Office of Responsible Research Practices (ORRP) for entry into the system and brief review of project materials. Then ORRP provides authorization to submit to WIRB. WIRB approves and amends documents received.
For OSU IRB-reviewed protocols: IRB analyst will screen submission and then forward for review by either the full IRB at a convened meeting or for expedited review by an IRB reviewer. Modification requests from the reviewers are received approximately one week after meeting/expedited review. Our research staff works with the PI to answer modifications promptly. Finally, approval is received.
- IRB/WIRB approval forwarded to OSP for final execution of the contract as necessary.
- Our research staff helps schedule any training that is required before opening the protocol to accrual.
- The research staff facilitate scheduling the Site Initiation Visit for industry studies and some multi-institutional studies.
- Lead clinical research coordinator conducts implementation meeting to ensure that all study team members understand the study and their respective responsibilities.
- Protocol is opened to accrual.
Our TeamIf you have a new study you just wrote, or you have been contacted by an industry sponsor or other institution about participating in their study, we can help.
Amy Minnema, Department Clinical Research Coordinator
For questions about how to begin your own neurosurgery study, contact any of the team members listed here. Visit studysearch.osumc.edu for clinical trial listings.