Data Solutions Group (DSG)
The Data Solutions Group (DSG) is Masonic Cancer Center (MCC) comprehensive data management group. The DSG is responsible for developing and standardizing data management plans that aid in the collection, analysis, integration, and reporting of quality data for all investigator-initiated clinical trials in the MCC portfolio.
Data Management Plans
Data management plans (DMPs) are developed trial-by-trial working closely with investigators and study staff
- The DMPs encompass all aspects of data collection, affiliate site management, correlative labs (sample data and data transmission requirements), IND reporting, and protocol amendment management
- Product processing management by assisting in setting up validation runs for product processing labs, providing OnCore access and training on specialized validation protocols, and creating CRFs for local and affiliate product data. The DSG can provide product data reports that include lot release information, analyte data and infusion related details for IND annual reports
Electronic Case Report Forms
The DSG supports development of electronic Case Report Forms (eCRFs) for each individual trial to capture study specific data that is required to answer all objectives and endpoints
Data Quality Throughout the Life Cycle of the Trial
- Early data analysis is done to confirm that data collection tools have been set up and used appropriately
- Interim data analysis is completed for many different status reports (FDA, Sponsor, etc.) as well as for abstracts and presentations.
- Final data analysis includes thorough, in depth quality checks and data sets (through CISS) before being sent to the Principle Investigator at study closure.
- At any time during a study, work with your Data Management Associate (DMA) on data requests.
OnCore and REDCap Support
- The DSG provides support with Clinical Trial Management System (OnCore) database management by:
- Setting up Access
- The DSG can help set up a REDCap survey or database
- Build REDCap forms and maintain data throughout life cycle of trial
- Setting up access
DSG and CISS collaborate in building dashboards for complex clinical trials
- The DSG works in collaboration with Principle Investigators, Biostatisticians, CTO, and CISS to perform complex data integration and analytics used for the publication of abstracts, manuscripts, and presentations.
- Specifically DSG can help generate and prepare graphs, figures, animations, tables, draft figure legends, introduction/background information, reference locating, and PowerPoint slides.
Reporting Trial Data to Federal Agencies
- Clinical Trials Reporting Program (CTRP) –The DSG will perform the following duties:
- Initial trial registration, amendments, and updates
- Quarterly patient accrual reporting from opening until study closure
- ClinicalTrials.gov - The DSG will perform the following duties:
- Initial trial registration information as mandated by the NIH and FDA
- Results reporting as mandated by the NIH and FDA