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 Disease 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 administrative oversight, multi-disciplinary faculty collaboration, and infrastructure for the conduct of early phase clinical trials via the Early Phase Clinical Trials Unit
- 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 centralized protocol-specific budget development, coverage analysis and pre-award management, and initiates sponsor contract negotiations via the Finance Unit
- 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 [Committee on Human Research or CHR], Biosafety Committee [BSC] and Radiation Safety Committee [RSC]), IND/IDE filing and maintenance, case report form creation, regulatory audit preparation, and protocol template development, all via the Protocol Development and Regulatory Unit. This unit is divided into three divisions: the Cooperative Groups Trials Division, the Institutional Trials Division and the Sponsored Trials Division.
- 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 (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. View instructions on how to acknowledge funding sources and how to obtain a PMCID.