Clinical Protocol & Data Management

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
  • 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