The Clinical Protocol Data Management (CPDM) Office provides infrastructural support for the conduct of clinical research at the HICCC. Its functions include: (1) clinical trial development (from concept to IRB approval), execution, and monitoring;(2) liaising with the HICCC Clinical Informatics Shared Resource (CISR) to ensure the optimal operation of clinical research information systems and databases, and (3) interfacing with regulatory and sponsoring agencies. To successfully accomplish these functions, the CPDM has developed 5 cores overseen by the Director of Clinical Operations and ultimately the Medical Director: Research Nursing, Clinical Research Coordination, Regulatory, Compliance, and Finance. The Research Nursing and Clinical Research (Data Management) cores consist of 8 Research Nurses, 2 Research Nurse Managers, 24 Clinical Research Coordinators (Data Managers), and 2 Clinical Research Coordinator Managers;these cores are responsible for trial assignments, supervision, and training. The Regulatory core consists of 8 Regulatory Research Coordinators and 1 Regulatory Manager;this core is responsible for interfacing with the IRB and maintaining files on each protocol executed by the CPDM (protocol, consents, amendments, annual reviews, etc.). The Compliance core consists of 3 Compliance Coordinators and 1 Compliance Manager;this core is responsible for monitoring investigator-initiated trials(IIT) per our NCI-approved DSMP and managing central registration processes, including eligibility review. The Finance core consists of 1 Finance Manager who is responsible for managing the CPDM operating budget and providing financial oversight of our trial portfolio. The CPDM works very closely with the HICCC Clinical Informatics Shared Resource (CISR), which is responsible for NCI reporting (including CTRP) and Velos support (training, CFR design, interface development, and security/oversight). The CPDM complements the PRMS, while providing investigators with efficient, seamless, and responsible clinical trial oversight for the Cancer Center. The Data and Safety Monitoring Committee (DSMC) Is responsible for data and safety monitoring of ongoing clinical trials. The DSMC prioritizes local investigator-initiated phase I, II, and III clinical trials. The committee will assume responsibility for other interventional trials when it is deemed appropriate by the Protocol Review and Monitoring System Committee (PRMSC), IRB or at the request ofthe PI.
Increasingly; discovery in cancer research is driven by analyses of multidimensional; genome-wide datasets; requiring the use of powerful computational resources and sophisticated analytical methods. The BISR enables cost-effective execution through the aggregation of expensive personnel and computational infrastructure that would be impractical to replicate in individual investigator labs.
|Sitko, Austen A; Kuwajima, Takaaki; Mason, Carol A (2018) Eye-specific segregation and differential fasciculation of developing retinal ganglion cell axons in the mouse visual pathway. J Comp Neurol 526:1077-1096|
|Tzoneva, Gannie; Dieck, Chelsea L; Oshima, Koichi et al. (2018) Clonal evolution mechanisms in NT5C2 mutant-relapsed acute lymphoblastic leukaemia. Nature 553:511-514|
|Wang, Gang; Biswas, Anup K; Ma, Wanchao et al. (2018) Metastatic cancers promote cachexia through ZIP14 upregulation in skeletal muscle. Nat Med 24:770-781|
|Chen, Yen-Hua; Kratchmarov, Radomir; Lin, Wen-Hsuan W et al. (2018) Asymmetric PI3K Activity in Lymphocytes Organized by a PI3K-Mediated Polarity Pathway. Cell Rep 22:860-868|
|Cho, Galaxy Y; Schaefer, Kellie A; Bassuk, Alexander G et al. (2018) CRISPR GENOME SURGERY IN THE RETINA IN LIGHT OF OFF-TARGETING. Retina 38:1443-1455|
|Zyablitskaya, Mariya; Munteanu, E Laura; Nagasaki, Takayuki et al. (2018) Second Harmonic Generation Signals in Rabbit Sclera As a Tool for Evaluation of Therapeutic Tissue Cross-linking (TXL) for Myopia. J Vis Exp :|
|Arnes, Luis; Liu, Zhaoqi; Wang, Jiguang et al. (2018) Comprehensive characterisation of compartment-specific long non-coding RNAs associated with pancreatic ductal adenocarcinoma. Gut :|
|Petersen-Jones, Simon M; Occelli, Laurence M; Winkler, Paige A et al. (2018) Patients and animal models of CNG?1-deficient retinitis pigmentosa support gene augmentation approach. J Clin Invest 128:190-206|
|Sones, Jennifer L; Merriam, Audrey A; Seffens, Angelina et al. (2018) Angiogenic factor imbalance precedes complement deposition in placentae of the BPH/5 model of preeclampsia. FASEB J 32:2574-2586|
|Park, Karen Sophia; Xu, Christine L; Cui, Xuan et al. (2018) Reprogramming the metabolome rescues retinal degeneration. Cell Mol Life Sci 75:1559-1566|
Showing the most recent 10 out of 331 publications