About Clinical Research at HDFCCC
The clinical shared resources in the HDFCCC are as follows and perform the listed functions:
- perform disease-specific scientific and feasibility review.
- 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.
- 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 Site Committees
- develops the HDFCCC Data Safety Monitoring Plan (DSMP)
- closes studies for non-compliance or safety issues
- provides a central core of personnel with expertise in all types of clinical trials management including protocol development and trial design, regulatory, compliance and financial management
- provides central oversight of research personnel (clinical research coordinators and data managers) via the Research Personnel Unit, which provides initial and ongoing training, education, monitoring, and mentorship
- provides protocol development and editing, consent form development, full regulatory compliance (NCI, FDA, DOD, peer reviewed sponsors or foundations, HDFCCC PRC, and the UCSF IRB, Institutional Biosafety Committee, and Radiation Safety Committee), IND/IDE filing and maintenance, case report form creation, regulatory audit preparation, and protocol template development, all via the Regulatory Unit.
- provides protocol navigation, study start-up and study maintenance services via the Protocol Project Mangers (PPMs) embedded in the programs
This unit is supported by a National Cancer Institute Cancer Center Support Grant (P30CA082103). Any publications related to work done by this core should reference grant number P30CA082103 and must include a PMCID as required by the NIH. View instructions on how to acknowledge funding sources and how to obtain a PMCID.
For more information on the CCSG, please email Erin Bank, PhD.