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.
- Audits
- ClinicalTrials.gov Compliance Oversight
- Consulting and Quality Pre-Review (QPR)
- Controlled Substances Program (CSP)
- Research Compliance Investigations
- Standard Operating Procedure (SOP) Development
- Youth Research Observation Program and Research Contributors
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.
- Dilution Solution Log (Form 1.2A)
- Administration Log (Form 1.2B)
- Individual Drug Log (Form 2)
- Authorized Agent List (Form 3)
- Security Release Form (Form 4)
- Internal Transfers of Schedule III-V Drugs (Form 7)
Forms can be found under the "Recordkeeping" section of the Controlled Substance page.
Title 21 Code of Federal Regulations Part 11, Electronic Records; Electronic Signatures (21 CFR 11)
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.
Tips for Researchers
University Policies:
Related Sites:
- Department of Health Human Services
- 45 CFR 46, Protection of Human Subjects (Subpart A) Basic HHS Policy for Protection of Human Research Subjects (external link)
- 45 CFR 46, Protection of Human Subjects (Subpart B) Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (external link)
- 45 CFR 46, Protection of Human Subjects (Subpart C) Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (external link)
- 45 CFR 46, Protection of Human Subjects (Subpart D) Additional Protections for Children Involved as Subjects in Research (external link)
- 42 CFR 93, Public Health Services Polices on Research Misconduct (external link)
- 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)
COMOR-C Team
- Daisy Lausell, Senior Director, Research Compliance and Operations
- Alana Mahley, Research Compliance Consultant
- Zach Polcyn, Research Compliance Analyst
- Melissa Riley, Research Compliance Analyst
- Sage Schmalenberger, Research Compliance Analyst
Contact: COMResearchCompliance@osumc.edu