Protocol Development and Monitoring

Purpose:

Protocol development (writing/editing), scientific and safety peer review, and study administrative monitoring are the responsibility of the Office of Protocol Development and Monitoring. This office collaborates with the CTSC in providing infrastructure for HCCC clinical investigators.

Services provided include:

1. Protocol writing and editing
2. Coordination of biostatistical consultation with the Biostatistics Core
3. Development of data and safety monitoring plans
4. Bi-annual and quarterly safety audits
5. Administrative support of the PRMC and DSMC
6. Communication with regulatory offices for oversight of clinical research

Contacts:

Administrative Office: 11510 PFP