Clinical trialObsUnknown
Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Obs
- Status
- Unknown
- Study type
- Observational
- Start
- 19 January 2017
- Expected end
- January 2020
- Enrollment
- 25,000 participants
- Sites
- 1
- Primary outcomes
- Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 January 2019
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Other: Data Management and Monitoring. 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.
Arm public domain (ClinicalTrials.gov)
Chronic Pancreatitis ():
Arm public domain (ClinicalTrials.gov)
Diabetes ():
Arm public domain (ClinicalTrials.gov)
Pancreatic Cancer ():
Primary outcome public domain (ClinicalTrials.gov)
Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) will monitor data quality and protocol compliance at all participating institutions. Time frame: 3 years.
Eligibility public domain (ClinicalTrials.gov)
Inclusion Criteria: * Participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through Consortium. Exclusion Criteria: * N/A
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 25000 participants (estimated).