Compliance

College of Medicine Office of Research – Compliance (COMOR-C)

The College of Medicine Office of Research Compliance (COMOR-C) is responsible for ensuring compliance with applicable laws, regulations, and policies pertaining to the conduct of research performed by the College of Medicine (COM). The following task areas are within the scope of COMOR-C.

If you are a COM researcher and have questions regarding compliance and how it affects your research, please contact: COMResearchCompliance@osumc.edu. 

For questions specific to the use of controlled substances in research, please contact: COMORCS@osumc.edu.

Internal Resources for COM: https://osumc.sharepoint.com/sites/COMResearch-Compliance.

Note: Conflicts interest (COI) in research, human gene transfer (HGT) research compliance research misconduct, and responsible conduct of research (RCR), is managed by The Ohio State University Office of Research Compliance (ORC). Export controls and foreign international engagements are managed by The Ohio State Office of Secure Research (OSR).

ClinicalTrials.gov

COMOR-C monitors compliance of COM clinical trials registered on ClinicalTrials.gov (external link).

ClinicalTrials.gov is a National Institutes of Health (NIH) nationwide registry of clinical trials 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 Principal Investigators (PI) are required to provide information and updates about applicable clinical trials (ACT) 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 Part 11 (42 CFR 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.

College of Medicine Controlled Substances Program (COM CSP)

COMOR-C oversees the compliance of COM researchers utilizing controlled substances in approved research, in alignment with COMOR-C standard operating procedures, The Ohio State University Office of Research Compliance (ORC) policy, Individual Investigator Use of Controlled Substances in Non-Therapeutic Research, U.S. Drug Enforcement Administration (DEA), and State of Ohio Board of Pharmacy (BOP) rules and regulations.

For questions about the COM Controlled Substances Program (CSP), please contact COMORCS@osumc.edu.

Title 21 Code of Federal Regulations Part 11, Electronic Records; Electronic Signatures (21 CFR 11)

Tips for Researchers

University Policies:

Related Sites:

COMOR-C Team

  • Daisy Lausell, Senior Director, Research Compliance and Operations
  • Alana Mahley, Research Compliance Consultant
  • Allyson Miller, Research Compliance Consultant
  • Sage Schmalenberger, Research Compliance Analyst
  • Shirley Ventresca, Research Compliance Analyst

Contact: COMResearchCompliance@osumc.edu