Data Solutions Group (DSG)

The Data Solutions Group (DSG) is a comprehensive data management team for the Masonic Cancer Center (MCC). DSG can provide the development of electronic case report forms, standardized data management plans, and support federal results reporting. These services contribute to the data collection, analysis, integration, and reporting for all investigator-initiated clinical trials in the MCC portfolio.

Services

CRTI-DSG Request Form

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Data Management Plans

  • Develop DMP on a trial-by-trial basis with investigators and study staff 
  • DMPs encompass all aspects of data collection and reporting, affiliate site management, correlative labs (sample data and data transmission requirements), IND reporting, protocol amendment management, and product data support.  

Electronic Case Report Forms

Development of electronic Case Report Forms (eCRFs)to capture study specific data required to answer all objectives and endpoints of the protocol.

Data Quality Plan

Data Quality 

  • Early data analysis to confirm all data points from the data collection tools have been captured appropriately.
  • Interim data analysis and reporting for study maintenance and various reports (FDA, Sponsor, etc.)
  • Final data analysis and study closeout.

  Data Monitoring

  • For Local Investigator Initiated Trials, the Primary Data Management Associate (DMA) will provide a data review schedule based on the DMP and the internal institutional monitoring schedule.

Data Curation for reports, abstracts, and presentations.

OnCore and REDCap Support

Clinical Trial Management System (OnCore) 

  • Study forms development
  • User Training
  • Troubleshooting
  • Internal and affiliate staff member training

REDCap Survey Application

  • Study forms and database development
  • User access setup and maintenance
  • Database quality checks and monitoring
  • End-user Troubleshooting
  • Internal and affiliate staff member training

Dashboard Development

  • DSG works in collaboration with Principal Investigators, Biostatisticians, TTL, and CISS to perform complex data integration and analytics used for the publication of abstracts, manuscripts, and presentations.
  • DSG can help generate and prepare graphs, figures, animations, tables, draft figure legends, introduction/background information, reference locating, and PowerPoint slides.
  • DSG and CISS collaborate in building dashboards for complex clinical trials

Reporting Trial Data to Federal Agencies

  • Clinical Trials Reporting Program (CTRP)
    • Initial trial registration, amendments, and updates
    • Quarterly patient accrual reporting from opening until study closure
  • ClinicalTrials.gov
    • Initial trial registration information as mandated by the NIH and FDA
    • Results reporting as mandated by the NIH and FDA

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