Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis Diabetes Pancreatic Cancer	Other: Data Management and Monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

25000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

Actual Study Start Date :

Jan 19, 2017

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Chronic Pancreatitis	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.
Diabetes	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.
Pancreatic Cancer	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

Intervention/Treatment

Chronic Pancreatitis

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.

Diabetes

Other: Data Management and Monitoring

Pancreatic Cancer

Other: Data Management and Monitoring

Outcome Measures

Primary Outcome Measures

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.