Chronic Pancreatitis, Diabetes, Pancreatic Cancer
Conditions
Keywords
Chronic Pancreatitis, Diabetes, Pancreatic Cancer, Data Management, Protocol compliance, Regulatory compliance, Consortium studies
Brief summary
The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data Management Center (CDMC) will provide high quality, efficient and consistent leadership and services in all aspects of data quality and assurance; data harmonization and management; while providing assistance to the projects in disseminating and interpreting those data. The CDMC PI will provide statistical (study design, analysis plans, data analysis, and interpretation), data management, and data monitoring/auditing (data quality assurance and harmonization) expertise for the proposed projects. The Cancer Center will have access to identifiable data from studies; analysis of this data will not be conducted under this protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will be conducted under a separate IRB approved data or lab protocol. The CDMC will leverage existing support, infrastructure, and resources from the Data Management and Coordinating Center for the Global Cancer Early Detection and the clinical expertise of the Division of Pathology/Lab Medicine at MDACC.
Interventions
Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) teams responsible for monitoring protocol and regulatory compliance for all consortium studies. MCSS responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
M.D. Anderson Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through Consortium.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) | 3 years | Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) will monitor data quality and protocol compliance at all participating institutions. |
Countries
United States
Contacts
Primary ContactYing Yuan, PHD
Outcome results
None listed