The OhioHealth Research & Innovation Institute provides an array services to support clinicians and research sponsors in conducting investigational clinical studies of new drugs, surgical devices, and diagnostics.
OHRI works with sponsors to identify their needs and host pre-study site visits in the clinic and research offices. OHRI also ensures that all research personnel complete the necessary study-specific training.
Documentation & Submissions
OHRI handles the preparation of the many FDA and sponsor-required documents (e.g., 1572, financial disclosure forms). OHRI organizes and completes the submission of the proposed study to the Institutional Review Board (IRB) as well as managing communications with the IRB for ongoing studies.
Budgeting & Contracts
OHRI experts identify research-related costs and incorporate them into the study budget. They coordinate contract negotiations and ensure the necessary legal agreements are executed.
OHRI provides clinical operations support, including research and regulatory coordinators as well as assistants at various levels, allowing for the flexibility needed to match research staff to the particular task at hand. Typical activities include:
- Review of patient charts for trial eligibility;
- Patient consent;
- Scheduling of research-related tests, procedures and follow-up visits;
- Reporting of adverse events;
- Completing and maintaining case report forms;
- Storage and tracking of investigational drugs and devices; and
- Scheduling and attending to all sponsor monitoring visits.
OHRI's clinical operations professionals perform regular monitoring of studies to ensure compliance with Federal regulations and to maintain high quality of research. They interact with sponsor monitoring representatives who regularly audit the clinical studies.
Upon completion of the trial, OHRI conducts a final monitoring, review of outstanding action items, and comprehensive review of all study regulatory documents. Arrangements for the long term storage of study regulatory files are made during this visit.
When regulatory agencies such as the US Food & Drug Administration audit an investigator's study, OHRI's clinical operations staff serve as a primary contact for the auditors and ensure that documents are available for review. They schedule meetings with the auditor(s) and investigator(s) to review all findings.
Clinical Operations Process Overview
Christine Gilliland, RN, CCRC, CCRA
Director, Clinical Operations