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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA033572-31
Application #
8764854
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
31
Fiscal Year
2014
Total Cost
$213,824
Indirect Cost
$86,546
Name
City of Hope/Beckman Research Institute
Department
Type
DUNS #
027176833
City
Duarte
State
CA
Country
United States
Zip Code
91010
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