Consultation, review, and monitoring

Protocol development consultation, scientific and safety peer review, and study administrative monitoring are the responsibility of the Office of Protocol Development and Monitoring, located within Holden Comprehensive Cancer Center's Clinical Research Services (CRS). This office collaborates with CRS in providing infrastructure for Holden clinical investigators.

Services

  1. Protocol development consultation and education.
  2. Coordination of biostatistical consultation with the Biostatistics Core.
  3. Development of data and safety monitoring plans.
  4. Accrual monitoring.
  5. Routine data and safety monitoring and quality assurance audits.
  6. Administrative support of the PRMC and DSMC.
  7. Communication with regulatory offices for oversight of clinical research.
  8. Clinical trial data management and reporting.

Contacts

Administrative Contacts

Biostatistician Contacts