The Clinical Protocol and Data Management Core (CPDMC) is a collaborative integrated unit staffed by professionals with expertise in protocol data management and clinical research informatics, to provide centralized infrastructure and support for the effective efficient conduct of clinical research. Working closely with the Biostatistics Core, this team blends technical and scientific expertise to provide City of Hope investigators with world-class research support and informatics solutions for clinical trials, observational studies, and outcomes research. The CPDMC offers comprehensive services to COH Cancer Center members including: protocol document management, electronic data capture, standardized clinical research staff training and education, honest broker process for accessing tissue samples, study recruitment tracking, patient safety decision support tools, data quality assurance and monitoring, multisite coordination, and customized and routine reports, including CCSG Summaries 3 and 4. The CPDMC provides input into developing protocols with respect to practicality and appropriateness of protocol management, study calendar, and data collection issues. Data Quality Monitors ensure that study research staff are fully trained in protocol management, data collection, and overall study conduct according to Good Clinical Practice (GCP) and COH policies. The CPDMC database monitors ensure that protocol and patient registration is carried out according to NCI guidelines. Key informatics services provided include;Clinical Trial Management Systems to manage planning, execution, and reporting of clinical research studies;Electronic Data Capture to provide electronic case report forms;and Clinical Research Decision Support to translate data into scientific decisions. Our emerging work on Translational Research Informatics includes implementation of the enterprise data warehouse, i2b2 open source system for cohort selection for tissue correlative studies, along with Electronic Lab Notebook and Laboratory Information Management Systems. For all these functions we use international architectural and vocabulary standards and project management methodologies to deliver clinical and translational informatics applications. In summary, the CPDMC delivers resources, education, and information management processes to establish best practices in accordance with FDA, GCP, regulatory requirements such as 21 CFR Part 11, and international data standards such as HL7, SNOMED, and LOINC The Core's services are available to all COH faculty, with COH Cancer Center members receiving the highest priority.
The overall goal of the Clinical Protocol and Data Management core facility is to provide centralized infrastructure and support for effective, efficient conduct of clinical research including protocol document management, electronic data capture, standardized training and education, study tracking, patient safety decision support tools, quality assurance and monitoring and reporting. This goal enhances the Cancer Center's dedication to developing innovative new disease-fighting strategies in the battle against cancer.
|Nakamura, Ryotaro; La Rosa, Corinna; Longmate, Jeffrey et al. (2016) Viraemia, immunogenicity, and survival outcomes of cytomegalovirus chimeric epitope vaccine supplemented with PF03512676 (CMVPepVax) in allogeneic haemopoietic stem-cell transplantation: randomised phase 1b trial. Lancet Haematol 3:e87-98|
|Kuo, Ching-Ying; Cheng, Chun-Ting; Hou, Peifeng et al. (2016) HIF-1-alpha links mitochondrial perturbation to the dynamic acquisition of breast cancer tumorigenicity. Oncotarget 7:34052-69|
|Zhou, Ting; Pan, Feiyan; Cao, Yan et al. (2016) R152C DNA Pol Î² mutation impairs base excision repair and induces cellular transformation. Oncotarget 7:6902-15|
|Wittenberg, Elaine; Ferrell, Betty; Goldsmith, Joy et al. (2016) Family Caregiver Communication Tool: a new measure for tailoring communication with cancer caregivers. Psychooncology :|
|Li, Zhongqi; Oganesyan, Diana; Mooney, Rachael et al. (2016) L-MYC Expression Maintains Self-Renewal and Prolongs Multipotency ofÂ Primary Human Neural Stem Cells. Stem Cell Reports 7:483-95|
|Sun, Virginia; Ruel, Nora; Chung, Vincent et al. (2016) Pilot study of an interdisciplinary supportive care planning intervention in pancreatic cancer. Support Care Cancer 24:3417-24|
|Leung, Amy; Trac, Candi; Du, Juan et al. (2016) Persistent Chromatin Modifications Induced by High Fat Diet. J Biol Chem 291:10446-55|
|Reid, Michael A; Lowman, Xazmin H; Pan, Min et al. (2016) IKKÎ² promotes metabolic adaptation to glutamine deprivation via phosphorylation and inhibition of PFKFB3. Genes Dev 30:1837-51|
|Thomas, Carissa M; Saulnier, Delphine M A; Spinler, Jennifer K et al. (2016) FolC2-mediated folate metabolism contributes to suppression of inflammation by probiotic Lactobacillus reuteri. Microbiologyopen 5:802-818|
|Champer, Jackson; Ito, James I; Clemons, Karl V et al. (2016) Proteomic Analysis of Pathogenic Fungi Reveals Highly Expressed Conserved Cell Wall Proteins. J Fungi (Basel) 2:|
Showing the most recent 10 out of 1181 publications