Regulatory Support
Regulatory Knowledge and Support
Regulatory Knowledge and Support enhances research operations by collaborating with internal Ohio State and Nationwide Children's Hospital research partners, core services and external entities, such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
Regulatory Knowledge and Support serves researchers by:
- Accelerating the process of obtaining regulatory approvals for clinical and translational research
- Developing and implementing efficient, compliant and ethical research proposals across all stages – from preclinical through clinical and post marketing stages
- Providing comprehensive clinical trial oversight through development of data safety monitoring plans, study monitoring, safety monitor oversight and data and safety monitoring boards
Primary Services and Support
Protocol/Consent Development
Plan and develop your protocols and your consent documents
IRB Submission
Find numerous resources to help navigate the IRB
ClinicalTrials.gov
Support to get your study registered on ClinicalTrials.gov
Ethical Considerations
Important ethical considerations with regulatory support
Essential Documents
Find essential documents that are used to evaluate the conduct and quality of clinical trials
IND/IDE Support
Helping research teams navigate the investigational new drug approval process
NIH Requirements
Support in navigating NIH requirements
Request an Regulatory Knowledge and Support Consultation
Regulatory Knowledge and Support provides expert consultations to navigate through regulatory and ethical requirements for clinical and translational research.
Request an Regulatory Knowledge and Support consultation through MyCTSI or by contacting CTSI-Regulation@osumc.edu.
Other regulatory related questions can be directed to CTSI-Regulation@osumc.edu so that the Regulatory Knowledge and Support team can identify how to best support you.
Initial regulatory consultations are a complimentary service provided by the CTSI and funded through NIH NCATS. Estimated costs for additional services are outlined in the Regulatory Knowledge and Support service fee table. For a study specific cost calculation to be included in a grant application please contact CTSI-Regulation@osumc.edu.