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:
-
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
