The Research Compliance Program is responsible for the internal auditing of all human research studies on campus as well as TTUHSC El Paso IRB approved research conducted on off-site locations. The research compliance officer (RCO) is responsible for monitoring research to ensure compliance with federal regulations, state laws, and institutional policies to protect the rights and welfare of human research participants.

To report concerns regarding the conduct of human research at TTUHSC El Paso, please call our hotline at 1-866-294-9352.

Regulatory Compliance Program

The audit program consists of:

• Routine Regulatory Audits
• Directed Audits / For Cause Audits
• Chart Review Audits
• eCRT and Effort Statement Monitoring

Regulatory Compliance Process

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, regulatory documentation, etc.)
• 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
• Ensuring that eCRT and Effort statement deadlines are met