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 of the PI.
| Sengillo, Jesse D; Lee, Winston; Bakhoum, Mathieu F et al. (2018) CHOROIDEREMIA ASSOCIATED WITH A NOVEL SYNONYMOUS MUTATION IN GENE ENCODING REP-1. Retin Cases Brief Rep 12 Suppl 1:S67-S71 |
| Kratchmarov, Radomir; Viragova, Sara; Kim, Min Jung et al. (2018) Metabolic control of cell fate bifurcations in a hematopoietic progenitor population. Immunol Cell Biol 96:863-871 |
| Xu, Christine L; Park, Karen Sophia; Tsang, Stephen H (2018) CRISPR/Cas9 genome surgery for retinal diseases. Drug Discov Today Technol 28:23-32 |
| Gartrell, Robyn D; Marks, Douglas K; Hart, Thomas D et al. (2018) Quantitative Analysis of Immune Infiltrates in Primary Melanoma. Cancer Immunol Res 6:481-493 |
| Moayedi, Yalda; Duenas-Bianchi, Lucia F; Lumpkin, Ellen A (2018) Somatosensory innervation of the oral mucosa of adult and aging mice. Sci Rep 8:9975 |
| Sengillo, Jesse D; Lee, Winston; Bilancia, Colleen G et al. (2018) Phenotypic expansion and progression of SPATA7-associated retinitis pigmentosa. Doc Ophthalmol 136:125-133 |
| Kroeger, Heike; Grimsey, Neil; Paxman, Ryan et al. (2018) The unfolded protein response regulator ATF6 promotes mesodermal differentiation. Sci Signal 11: |
| Hopkins, Benjamin D; Pauli, Chantal; Du, Xing et al. (2018) Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature 560:499-503 |
| Ghorpade, Devram S; Ozcan, Lale; Zheng, Ze et al. (2018) Hepatocyte-secreted DPP4 in obesity promotes adipose inflammation and insulin resistance. Nature 555:673-677 |
| Jauregui, Ruben; Thomas, Amanda L; Liechty, Benjamin et al. (2018) SCAPER-associated nonsyndromic autosomal recessive retinitis pigmentosa. Am J Med Genet A : |
Showing the most recent 10 out of 331 publications
