Monitoring and Quality Assurance
- All Sponsor-Investigator studies are monitored for the following:
- Protocol compliance and deviations
- Informed consent
- Adherence to GCP
- Adherence to regulations, guidelines, and SOPs
- IRB applications, approval notices, reports, correspondence
- Conflict of interest/financial disclosure
- Safety reporting
- Pharmacy and investigational product (IP) accountability
- Laboratory procedures
- Training records
- Site support
- Adverse events (AE)/safety review
- Essential document review
- Source data verification (SDV)
- Site performance assessment
- Study progress against milestones
- In addition, the CRSO QA team provides the following services, as needed:
- Review Investigator-Initiated Trials (IIT) protocols prior to study start-up
- Provide mentorship and training for study teams
- Conduct pre-reviews prior to FDA and audits by other entities
- Develop Standard Operating Procedures and guidance documents
Email: CRSOQA@hsc.utah.edu