Ογ½ΆΦ±²₯

Compliance

To report concerns regarding the conduct of Human Research at Ογ½ΆΦ±²₯, please call our hotline at 1-866-294-9352

Research Compliance Program

The Research Compliance Program is responsible for internal auditing of human research studies to monitor compliance with federal regulations, state laws, and Ογ½ΆΦ±²₯ institutional policies for the protection of the rights and welfare of human research participants.

The audit program consists of:

• Routine Regulatory Audits
• Directed Audits
• Financial Monitoring

The audit process includes monitoring activities such as:

• Review of investigator study records (including signed informed consent documents, study-related data collection forms, protocol and amendments, adverse event documentation, correspondence related to the study, drug/device accountability records, and regulatory documentation)
• Review of source documentation (such as medical records)
• Observation of the informed consent process
• Interviews of investigators and research personnel
• Oversight of revenues and expenditures
• Review of Institutional Review Board (IRB) records
• Evaluation of industry-sponsored monitoring reports
  
  

The Regulatory Audit Process

• Research Compliance staff contacts Principal Investigator and Study Coordinator to notify and schedule audit
• Audit is conducted in accordance with established procedures
  • Opportunity for questions and discussion between Research Compliance staff and study personnel
  • Preliminary findings are discussed at conclusion of on-site audit
  • Written report of audit findings is sent to Principal Investigator with copies sent to others as appropriate
• A plan of correction to address findings must be submitted by established deadlines
• Follow-up audits are scheduled as necessary 

Research Integrity Office Grant Compliance

Grant Allowable Expenditure Policy

Contact Information