About Clinical Research at HDFCCC

ITR UCSF Research

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

PRMS:  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 Disease Site Committees
  • develops the HDFCCC Data Safety Monitoring Plan (DSMP)
  • closes studies for non-compliance or safety issues

CRSO:  Clinical Research Support Office:

This unit is supported by a National Cancer Institute Cancer Center Support Grant (5P30CA082103). Any publications related to work done by this core should reference grant number 5P30CA082103 and must include a PMCID as required by the NIH. For complete instructions on how to acknowledge funding sources, please see http://grants.nih.gov/grants/acknow.htm. For more information on how to obtain a PMCID, please see http://publicaccess.nih.gov/submit_process.htm.

For more information on the CCSG, please contact Kate Shumate at kate.shumate@ucsf.edu.