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Clinical Protocol & Data Managment (CPDM)

Co-Director: Adina Londrc, M.D.
Co-Director: Ajay Shah, Ph.D.
Manager: Karen Rickard


Clinical Protocol and Data Management (CPDM) is led by Adina Londrc, M.D. (Director of Clinical Research Information Support), and Ajay Shah, Ph.D. (Director of Research Informatics) with Karen Rickard serving as manager. CPDM provides centralized infrastructure and support for effective, efficient conduct of clinical research.

CPDM offers comprehensive services to City of Hope's comprehensive 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, multi-site coordination, and customized and routine reports.
 
CPDM Services
Protocol Management
 
  • Protocol Document Management, i.e. Clinical Trials On-lineSM
  • Clinical Trials Reporting Program (CTRP) Reporting
  • Clinical Trials Management Systems
  • Research Informatics Architecture

Electronic Data Capture
 
  • Case Report Form Development
  • Data Collection Grid Creation
  • Forms Instructions
  • Metadata Management
  • Electronic Case Report Form Construction
  • Laboratory Data Capture
  • Enterprise Data Warehouse

Training
 
  • Protocol Management Training
  • Case Report Form Training
  • Training Workshops and In-Services
  • Training Tools and Manuals
  • E-learning
  • Communities of Practice

Study Recruitment Management
 
  • Subject Registration
  • Accrual Monitoring
  • Online Subject Registration
  • Online Informed Consent Linkage

Study Conduct Management
 
  • Data Quality Monitoring
  • Multi-Site Coordination
  • Audit Preparation
  • Programmatic Edit Checks
  • Subject Safety Decision Support

Reporting and Analysis Support
 
  • Monitoring and Validating Accruals
  • Data Curation for Statistical Analysis
  • Database Lock
  • Decision Support
  • Data Mart Creation
  • Online Informed Consent Linkage

Data Integration Querying
 
  • De-identified Cohort Discovery (iCoDE)
  • Cancer Registry Data
  • Diagnosis and Procedures
  • Tissue Specimen Information
 

Abstract for Grants

The Clinical Protocol and Data Management (CPDM) 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 CPDM 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, multi-site coordination, and customized and routine reports.
 
The CPDM 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 CPDM 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 21CFR Part 11, and international data standards such as HL7, SNOMED, and LOINC.

Pricing

Pricing

Prices and availability vary. Please contact us for current information.

Comprehensive Cancer Center
In recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.

Using the Facility

The CPDM services are available to all City of Hope faculty, with members of City of Hope's comprehensive cancer center receiving the highest priority.

To request service or discuss how we can facilitate your scientific goals, please contact us.
 

Clinical Protocol & Data Managment Core Team

Clinical Protocol & Data Management (CPDM)

Clinical Protocol & Data Managment (CPDM)

Co-Director: Adina Londrc, M.D.
Co-Director: Ajay Shah, Ph.D.
Manager: Karen Rickard


Clinical Protocol and Data Management (CPDM) is led by Adina Londrc, M.D. (Director of Clinical Research Information Support), and Ajay Shah, Ph.D. (Director of Research Informatics) with Karen Rickard serving as manager. CPDM provides centralized infrastructure and support for effective, efficient conduct of clinical research.

CPDM offers comprehensive services to City of Hope's comprehensive 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, multi-site coordination, and customized and routine reports.
 
CPDM Services
Protocol Management
 
  • Protocol Document Management, i.e. Clinical Trials On-lineSM
  • Clinical Trials Reporting Program (CTRP) Reporting
  • Clinical Trials Management Systems
  • Research Informatics Architecture

Electronic Data Capture
 
  • Case Report Form Development
  • Data Collection Grid Creation
  • Forms Instructions
  • Metadata Management
  • Electronic Case Report Form Construction
  • Laboratory Data Capture
  • Enterprise Data Warehouse

Training
 
  • Protocol Management Training
  • Case Report Form Training
  • Training Workshops and In-Services
  • Training Tools and Manuals
  • E-learning
  • Communities of Practice

Study Recruitment Management
 
  • Subject Registration
  • Accrual Monitoring
  • Online Subject Registration
  • Online Informed Consent Linkage

Study Conduct Management
 
  • Data Quality Monitoring
  • Multi-Site Coordination
  • Audit Preparation
  • Programmatic Edit Checks
  • Subject Safety Decision Support

Reporting and Analysis Support
 
  • Monitoring and Validating Accruals
  • Data Curation for Statistical Analysis
  • Database Lock
  • Decision Support
  • Data Mart Creation
  • Online Informed Consent Linkage

Data Integration Querying
 
  • De-identified Cohort Discovery (iCoDE)
  • Cancer Registry Data
  • Diagnosis and Procedures
  • Tissue Specimen Information
 

Abstract for Grants

Abstract for Grants

The Clinical Protocol and Data Management (CPDM) 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 CPDM 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, multi-site coordination, and customized and routine reports.
 
The CPDM 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 CPDM 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 21CFR Part 11, and international data standards such as HL7, SNOMED, and LOINC.

Pricing

Pricing

Pricing

Prices and availability vary. Please contact us for current information.

Comprehensive Cancer Center
In recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.

Using the Facility

Using the Facility

The CPDM services are available to all City of Hope faculty, with members of City of Hope's comprehensive cancer center receiving the highest priority.

To request service or discuss how we can facilitate your scientific goals, please contact us.
 

Clinical Protocol & Data Managment Team

Clinical Protocol & Data Managment Core Team

Research Shared Services

City of Hope embodies the spirit of scientific collaboration by sharing services and core facilities with colleagues here and around the world.
 

Recognized nationwide for its innovative biomedical research, City of Hope's Beckman Research Institute is home to some of the most tenacious and creative minds in science.
City of Hope is one of only 41 Comprehensive Cancer Centers in the country, the highest designation awarded by the National Cancer Institute to institutions that lead the way in cancer research, treatment, prevention and professional education.
Learn more about City of Hope's institutional distinctions, breakthrough innovations and collaborations.
Support Our Research
By giving to City of Hope, you support breakthrough discoveries in laboratory research that translate into lifesaving treatments for patients with cancer and other serious diseases.
 
 
 
 
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