COMOR-CT monitors compliance of COM Applicable Clinical Trials (ACT) registered on ClinicalTrials.gov (external link) in order to detect and prevent potential compliance risks that could impact the COM. 

ClinicalTrials.gov is a National Institutes of Health (NIH) nationwide registry of applicable clinical trials (ACT), consisting of an online database for clinicians, researchers, and patients of publicly and privately-funded human subjects research (HSR) studies on a variety of diseases and conditions. Sponsors or investigators are required to provide information and updates about ACTs on ClinicalTrials.gov in accordance with (IAW) Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and Title 42 Code of Federal Regulations (CFR) Part 11, Clinical Trials Registration and Results Information Submission.

For information about College of Medicine department-specific Protocol Registration System (PRS) administrators, contact: COM Research Compliance at: COMResearchCompliance@osumc.edu.

Downloadable Guides 

ClinicalTrials.gov Frequently-asked Questions (FAQ) (PDF)

Managing ClinicalTrials.gov  (PDF)

Standard Operating Procedure 100-001 Clinical Trials.gov Compliance (PDF)

In March 1997, the U.S. Food and Drug Administration (FDA) issued regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, signatures and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

Sponsors of FDA-regulated research may request that researchers confirm whether The Ohio State University’s (Ohio State) Electronic Health Record (EHR) is compliant with 21 CFR 11.

• Please refer to this memorandum, Guidance for Responding to Inquiries about Ohio State EHR Compliance with 21 CFR 11 (internal access only).
• For assistance completing a Sponsor IT checklist, please refer to the following contacts:
  • For CCRM/CTMO-managed studies, and for studies performed by groups not yet within CCRM: COMRTS@osumc.edu. 
  • For CTO-managed studies: cancer-it@osumc.edu

  For questions about the memorandum or these instructions, please contact ITRiskAndCompliance@osumc.edu.

• Faculty Conflict of Commitment (Office of Academic Affairs) (PDF)
• Conflict of Interest and Work Outside the University, 1.30 (PDF)

• Food and Drug Administration
  • 21 CFR 50, Protection of Human Subjects (external link) 
  • 21 CFR Part 54, Financial Disclosure by Clinical Investigators (external link) 
  • 21 CFR 56, Institutional Review Boards (external link) 

• The Enterprise for Research, Innovation and Knowledge (ERIK) (external link)
• The Ohio State University Office of Research (external link) 
  • The Ohio State University Office of Research Compliance (external link) 
• Office of Responsible Research Practices (ORRP) (external link) 
  • Institutional Animal Care and Use Committee (IACUC) (external link) 
  • Institutional Review Board (IRB): Human Subjects (external link) 
  • Investigator Guidance (external link)  
  • Institutional Biosafety Committee (IBC) (external link)