Research Integrity Office - Compliance

Compliance

To report concerns regarding the conduct of Human Research at TTUHSC, 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 TTUHSC 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 Expenditures FAQs

Grant Allowable Expenditure Policy

Contact Information