Providing you with a flexible data management system customized to you and your study’s needs is what we designed CDART to do best. Tell us what you need, and we can apply CDART to it.
CDART (Carolina Data Acquisition and Reporting Tool) is an enterprise-grade, scalable, web-based data management tool made for multi-center clinical trials, observational studies, and patient registries.
We’ll work with you to customize the CDART data management system to meet your needs. Instead of changing your study to fit a system, we customize CDART to the needs of your study and your staff.
We applied decades of experience when creating CDART. It’s a well-tested system, with five years of proven and consistent reliability.
Among CDART features are versatile form entry capabilities, custom reporting options, and indispensable patient information confidentiality and data security attributes.
Versatile Form Entry Capabilities:
You and your staff can use CDART to fill out simple or intricate forms with these capabilities:
- Capture data in real time using validation to prevent errors.
- Move faster, with fields that change or skip to other fields, in real-time, based on previous data that was just entered (this is also known as form-specific field dependencies).
- Attach files to any form, such as PDFs of signed consent forms, images, or documents.
- Enter data anywhere there’s an internet connection, on any browser, computer, or tablet.
- Calculate data in real-time, such as using a birthday to populate a study participant’s age.
- Resolve data discrepancies through CDART queries and reports within the system, allowing site staff to find and correct their own queries as they work.
- Capture data into CDART from external sources, like labs, reading centers, and electronic medical records, with automatic data cleansing and formatting. (You may have heard this called ETL: Extract, Transform, and Load.) We can also create data collection instruments for specialized data entry (e.g. Universal Numbering System for patient dental records).
- Create reports within the electronic data capture system using data immediately after it is entered. Using data quickly and efficiently you can customize reports in CDART using a variety of options for output such as graphs or tabular format.
- For Randomized Clinical Trials, determine patient eligibility and perform complex algorithms to determine treatment assignment.
- Create forms within the integrated form design with a preset library in CDART. Forms can have large inputs (including complex skip logic), and they can have calculated fields based on other data values, links to external websites, and integrated reports or documents.
Custom Reporting Options:
Whatever information you require for reporting in any timeframe can be set up in CDART. Because CDART includes a report-writing tool, study-specific reports can be added easily.
Reports like enrollment status, patient tracking, data query resolution, adverse events, and form completion are a few options, and the integrated tool is customizable for graphical or tabular reporting. For example, CDART can create bar charts to display recruitment at each study site location.
Data collected in CDART can be exported for use in statistical software. Export formats include .csv and CDISC ODM Data Export.
Patient Information Confidentiality and Data Security Attributes:
CDART has robust security features such as secure logins and encrypted data transmission. User logins are set with your specified access privileges to ensure data safety and patient confidentiality. Audit logs capture any modifications made to the data.
We created CDART to be compliant with FDA 21 CRF Part 11 compliance, and with the Federal Information Security Act (FISMA).
The systems that host CDART technologies reside in a secure server environment within a severe weather-proof center on the campus of the University of North Carolina – Chapel Hill (UNC). The data center is governed by standard UNC and UNC School of Medicine information security guidelines.
A third-party vendor performs weekly vulnerability detection scans. The vendor has full administrative credentials to perform maximum detective techniques. Real-time virus protection software is implemented, and weekly full system virus scans are performed.
Who Created CDART:
CDART was designed and implemented at the University of North Carolina – Chapel Hill by the Collaborative Studies Coordinating Center (CSCC), part of the UNC Department of Biostatistics.
The CSCC is the oldest coordinating center continuously funded by the National Institutes of Health (NIH) in the country. We pioneered some of the earliest advances in data management tools for research.
Learn More – Contact Us
Study data management start-up and deployment is easy and fast using CDART. For more information about CDART data management capabilities, please contact Hope Bryan, IT and Data Manager, at email@example.com
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