About Clinical Research at HDFCCC

ITR UCSF Research

The clinical shared resources in the HDFCCC are as follows and perform the listed functions:

PRMS:  Program/Disease Site Committees:

  • perform disease-specific scientific and feasibility review.

PRMS:  Protocol Review Committee (PRC):

  • performs HDFCCC-wide scientific and feasibility review
  • monitors for adequate accrual and ongoing scientific relevance
  • closes studies that do not accrue or lose scientific relevance.

DSM:  Data and Safety Monitoring (DSM):

  • conducts internal audits on investigator-initiated* clinical trials
  • assesses results of internal and external audits
  • approves cohort dose escalations in investigator-initiated* phase I clinical trials
  • reviews planned interim analyses on investigator-initiated* clinical trials
  • evaluates safety and study design concerns
  • oversees SAE and toxicity reporting from Program/Disease Site Committees
  • develops the HDFCCC Data Safety Monitoring Plan (DSMP)
  • closes studies for non-compliance or safety issues

CRSO:  Clinical Research Support Office: