A National Cancer Institute-designated Comprehensive Cancer Center

Make an appointment: 800-826-HOPE

Clinical Protocol & Data Management Core (CPDMC)

Clinical Protocol & Data Managment Core (CPDMC)
Co-Director: Adina Londrc, M.D.
Co-Director: Ajay Shah, Ph.D.
Core Managers: Karen Rickard & Gabe Peterson


The Clinical Protocol and Data Management Core (CPDMC) 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 and Gabe Peterson serving as Core Managers. The Core provides centralized infrastructure and support for effective, efficient conduct of clinical 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, multi-site coordination, and customized and routine reports.
 
CPDMC Core 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 FormDevelopment
  • 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 & 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 & 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 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, multi-site coordination, and customized and routine reports.
 
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 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 Core's services are available to all City of Hope faculty, with City of Hope Cancer Center members 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

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.
 
 
 
 
Media Inquiries/Social Media

For media inquiries contact:

Dominique Grignetti
800-888-5323
dgrignetti@coh.org

 

For sponsorships inquiries please contact:

Stefanie Sprester
213-241-7160
ssprester@coh.org

Christine Nassr
213-241-7112
cnassr@coh.org

 
CONNECT WITH US
Facebook  Twitter  YouTube  Blog
 
NEWS & UPDATES
  • An aspirin a day might help keep breast cancer away for some breast cancer survivors, a new study suggests. Obese women who have had breast cancer could cut their risk of a recurrence in half if they regularly take aspirin or other nonsteroidal anti-inflammatory drugs, called NSAIDs, report researchers from the...
  • Christine Crews isn’t only a fitness enthusiast, she’s also a personal trainer and fitness instructor. Being active defines her life. So when she was diagnosed with bladder cancer at age 30, she decided she absolutely couldn’t let the disease interfere with that lifestyle. And it didn’t. For t...
  • Cancer treatment and the cancer itself can cause changes in your sense of taste or smell. These side effects typically subside after treatment ends, but there are ways to help alleviate those bitter and metallic tastes in your mouth. Here are tips from the National Cancer Institute to help keeps tastes and food...
  • Immunotherapy — using one’s immune system to treat a disease — has been long lauded as the “magic bullet” of cancer treatments, one that can be more effective than the conventional therapies of surgery, radiation or chemotherapy. One specific type of immunotherapy, called adoptive T cell thera...
  • Today, when cancer spreads from its original site to other parts of the body, a process known as metastasis, patients face an uphill battle. Treatments are poorly effective, and cures are nearly impossible. Further, incidence rates for these types of cancers are increasing – particularly for cancers that have s...
  • Thanks to the California Institute for Regenerative Medicine (CIRM), high school students across the state gained valuable hands-on experience with stem cell research this summer. City of Hope hosted eight of those students. As part of the CIRM Creativity Awards program, the young scholars worked full time as m...
  • Radiation therapy can help cure many children facing Hodgkin lymphoma and other cancers. When the radiation is delivered to a girl’s chest, however, it can lead to a marked increase in breast cancer risk later in life. A recent multi-institutional study that included City of Hope’s Smita Bhatia, M.D., M.P.H., t...
  • A patient diagnosed with cancer – especially a rare, advanced or hard-to-treat cancer – needs specialized care from exceptionally skilled and highly trained experts. That kind of care saves lives, improves quality of life and keeps families whole. That kind of care is best found at comprehensive cancer centers ...
  • Appetite loss may be common during cancer treatment, lasting throughout your therapy or only occasionally, but it can be managed. Below are tips from the National Cancer Institute (NCI) that can help you keep your weight up and, in doing so, keep your body well-nourished. (See the end of this article for a deli...
  • Myelodysplasia, sometimes referred to as myelodysplastic syndrome or MDS, is a rare group of blood disorders caused by disrupted development of blood cells within the bone marrow, resulting in a decreased number of healthy blood cells. People diagnosed with the condition, considered a precancer, may be at great...
  • Twenty years ago, scientists discovered that a mutation in a gene now widely known as BRCA1 was linked to a sharply increased risk of breast cancer, paving the way for a new chapter in identifying women at risk of the disease and giving them options to potentially avoid an aggressive cancer. But experts have al...
  • The Eugene and Ruth Roberts Summer Student Academy at City of Hope turned 54 this year. Marking the occasion, the academy announced a new scholarship in honor of longtime director Paul Salvaterra, Ph.D. Salvaterra, a professor in City of Hope’s Department of Neurosciences, has led the summer student acade...
  • Stevee Rowe has a very personal connection to the research she’s conducting on neural stem cells: Her late father participated in a City of Hope clinical trial involving neural stem cells. Rowe — her full name is Alissa Stevee Rowe, but she prefers to use her middle name — will enter her senior year at the [...
  • Although multiple myeloma is classified as a blood cancer, patients with this disease often experience bone-related symptoms, too. This includes bone pain, frequent fractures and spots of low bone density or bone damage that show up during a skeletal scan. Here, Amrita Krishnan, M.D., director of City of Hope&#...
  • Women using some birth control pills, specifically those with high doses of estrogen and a few other formulations, may be at an increased risk of breast cancer, a new study has found. At first glance, the findings seem alarming, but a City of Hope breast cancer surgeon is warning against overreaction. The study...