Data Services

The Data Solutions Group (DSG) provides comprehensive data management support with OnCore, REDCap, and report your trial data to ClinicalTrials.gov and Clinical Trials Reporting Program (CTRP). 

Data Management Plans

• Developed trial-by-trial basis

• Include data collection, affiliate site management, correlative labs, IND reporting and protocol management. 

• 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 Analysis

• 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.

• The DSG can help set up a REDCap survey or database.

Dashboard Development

• DSG and CISS collaborate in building dashboards for complex clinical trials

Data Visualization

• 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.

Report 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

• Trial amendments and regular updates

• Results reporting as mandated by the NIH and FDA

•  

To request DSG services please click on the relevant links below. 

• CRTI-DSG Request Form

• REDCap

• OnCore Request Form

For further information, please contact DSG or email dsg1@umn.edu.

This is a cancer center supported resource with a subsidized rate for MCC members.

Best Practices Integrated Informatics Core (BPIC) and Clinical Informatics Shared Systems (CISS) provides centralized clinical informatic services to MCC investigators. These services include access to clinical and genomic databases, data extraction and advanced analytics. 

For consultation complete, Consultation form.

For further information on services and rates please go to CISS webpage or contact CISS (ciss@umn.edu).

This is a cancer center supported resource with a subsidized rate for MCC members.

With a focus on data associated with a large-scale molecular studies, our services are developed on an ad hoc basis depending on the needs of the given researcher. These needs may be as straightforward as working with researchers to access tools available within the University (such as MSI). 

Requests for assistance will be placed in order of priority as listed below:

• Projects that provide funding for Cancer Informatics experts in the core

• Grant preparation

• Data analysis for cancer-related projects

Cancer bioinformatics also provided assistance with experimental design involving large-scale molecular studies, write bioinformatic components of grant proposals, conduct analysis of high throughput molecular data (e.g., mRNA, miRNA, insertional mutagenesis studies, ChIP-seq), and assist with the interpretation of results. 

To request consultation, fill out the request form. For more information, go to https://cancer.umn.edu/cancer-bioinformatics or contact Aaron Sarver at sarver@umn.edu.

This is a cancer center supported resource with a subsidized rate for MCC members.

The Center for Clinical Quality & Outcomes Discovery and Evaluation (C-QODE) assists data-centric research by democratizing access to clinical and non-clinical researchers. For more information please go to https://cqode.umn.edu/ or contact cqode@umn.edu.

Publicly available datasets are available through numerous resources that is available to MCC investigators. 

These include:  

• UMN EHR (i.e. Acute DataMart) 

• NTDB (National Trauma Data Bank)

• NSQIP (National Surgical Quality Improvement Program) 

• TQIP (Trauma Quality Improvement Program)

• The Surveillance, Epidemiology, and End Results (SEER)

• National Cancer Database

• MNCCTN

• National Center for Health Statistics

• Behavioral Risk Factor Surveillance System

The Office of Science and Technology Policy released a memo that states all federally funded data must be shared as broadly as possible by 2025. Funding agencies have already begun complying with this upcoming mandate. The NIH, for example, adopted a new Data Management and Sharing Policy as of January 2023. Investigators are required to have a data management and sharing plan in their grant proposals. Data Solutions Group can work with investigators in developing a data management plan for lab research or clinical trials. 

Research Data Services (RDS) at UMN libraries offers data management language, education, consultation, and services for MCC investigators. 

Data Management Plan Assistance

• RDS will review Data Management Plans (DMPs) and Data Management and Sharing Plans (DMSPs) for any funding agency prior to grant submission to offer feedback. Request a plan review or consultation from RDS.

• Learn more about NIH requirements in the RDS Guide to the NIH Data Management and Sharing Policy.

• Download the NIH DMSP template and sample plans. 

• Find templates and suggested language for other funders in the DMPTool. RDS can assist with locating additional resources as needed.

Where to Share your Data

• Explore the list of NIH-Supported Data Sharing Resources to see whether a repository listed under your Institute or Center, subject area, or model system is a good fit for your data.

• Explore generalist repositories that accept data from any discipline or type.

• Data that can be made completely open access may be shared in the Data Repository for the University of Minnesota (DRUM). 

Data Management Education 

• Attend an RDS data management workshop or virtual training.

• Request a tailored presentation or workshop from RDS for your lab, department, or course. 

Contact RDS at data@umn.edu for more information. 

MSI provides advanced research computing infrastructure and expertise to the University of Minnesota investigators.  They provide assistance on a broad range of services including research computing, big data analysis, data mining, bioinformatics, and genomics. 

To request a consultation, go https://www.msi.umn.edu/  or contact MSI at help@msi.umn.edu, for more information.