Data Solutions Group
The Data Solutions Group (DSG) is responsible for developing and standardizing plans that aid in the collection, analysis, integration, and reporting of quality data for all investigator-initiated clinical trials in the Masonic Cancer Center portfolio.
Support for all Aspects of Data Management and Research Support Services
The DSG provides support for all aspects of data management and research support services beginning with the initial trial characterization of a proposed study, to interim data analysis and quality checks, through study closeout reporting (clinicaltrials.gov and CTRP) and analysis.
The data solutions team works closely with investigators and study staff on a trial-by-trial basis to understand the support requirements and deliverables of a study, and to ensure accurate and timely completion by creating study specific Data Management Plans (DMPs).
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. Electronic Case Report Forms (eCRFs) are developed for each individual trial to capture study specific data that is required to answer all objectives and endpoints.
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. At any time during a study, work with your DMA on data requests.
Initial trial characterization: Working with the Trial Resource Utilization Committee (TRUC) to ensure that all necessary clinical trial details required for reporting purposes are entered into OnCore correctly during the initial phase of trial set up (i.e. Data Table 3 and 4 reports)
Data monitoring and quality assurance
Product processing management: Setting up validation runs for affiliate site product processing labs, providing OnCore access and training on specialized validation protocols, and creating CRFs for local and affiliate product data.
- Providing product data reports: including lot release information, analyte data, and infusion related details for IND annual reports
Data analysis and reporting
- eCRF development and testing
- Early: We perform high-level data analysis early in the life of a clinical trial to confirm that data collection tools have been set up and are being completed appropriately.
- Interim: Interim data analysis is used for many different status reports (FDA, Sponsor, etc.) as well as for abstracts and presentations.
- Final: Thorough, in depth quality checks and data sets (through CISS) will be provided at study closure to the Principle Investigator containing the data necessary to answer the protocol directed study end points.
- Provide mapping specifications/documentation to CISS team outlining what data needs to be visualized and it’s location for use.
Study specific data management planning and development
- Data Management Planning for Investigator Initiated Trials
- Clinical and affiliate staff CRF training
Clinical Trial Management System (OnCore) database management
Publication and presentation assistance
- Utilizing final data sets to generate graphs, figures, animations, and tables for publication in abstracts, manuscripts, and presentations.
- Preparation of draft figure legends, introduction/background information, and reference locating.
- Creation of PowerPoint slides for presentation of data and analysis
Clinical Trials Reporting Program (CTRP) – The NCI's Clinical Trials Reporting Program maintains a comprehensive database of information on all NCI-supported interventional clinical trials open to accrual as of January 1, 2009. The purpose is to help identify gaps and duplicate studies in clinical research, facilitates clinical trial prioritization, and standardizes trial data capture and sharing. The Data Solutions group will perform the following duties for the benefit of Principle Investigators and the Clinical Trials Office.
- Initial trial registration, amendments, and updates
- Quarterly patient accrual reporting from opening until study closure
ClinicalTrials.gov - is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world, aiming to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. The Data Solutions group will perform the following duties for the benefit of Principle Investigators and the Clinical Trials Office.
Initial trial registration information as mandated by the NIH and FDA including:
- Disease or condition
- Intervention (for example, the medical product, behavior, or procedure being studied)
- Title, description, and design of the study
- Requirements for participation (eligibility criteria)
- Locations where the study is being conducted
- Contact information for the study locations
Final Summary Results submission
- Description of study participants (the number of participants starting and completing the study and their demographic data)
- Outcomes of the study
Summary of adverse events experienced by study participants