Choosing a Data Management System for Research
Academic Information Systems offers two research data capture development solutions – Velos and REDCap. Both solutions are recommended over Excel, Access, and FileMaker because they satisfy HIPAA Privacy Rule requirements.
The Velos Clinical Trials Management System is designed to aid with patient recruitment, protocol management, budgeting and financials, electronic data capture, data safety monitoring, adverse event reporting, and patient scheduling. This system offers interfaces with both EPIC and eIRB, eliminating redundant entry in multiple systems. Velos should be used for FDA-governed clinical trials. It requires consulting with the Research Data Management Group to efficiently plan your study.
REDCap is a research data capture system originally designed at Vanderbilt University. It is used at more than 307 institutions worldwide – including UT Southwestern Medical Center. It is a self-service system in which the researcher defines the database fields either in a spreadsheet or with the help of user-friendly web tools. Once the database fields have been finalized, researchers can start entering data immediately. AIS can help define and refine a database.
|Who manages projects/surveys?||Users must have a Southwestern ID, Children’s Health℠ ID, or Parkland ID||Users must have a Southwestern ID for identified studies.|
|Study size/complexity||Can be used for studies of all sizes but is best suited to investigator-initiated studies requiring case report form or longitudinal registries||Can be used for studies of all sizes|
|HIPAA-compliant||Can be used for fully identified and anonymized studies||Can be used for fully identified and anonymized studies|
|21 CRF Part 11 compliance||Yes|
|Web-enabled||A web application (behind firewall, need VPN)||A web application|
|Cost||No cost for using the application. There is a $90/hour charge for AIS to create complex forms and design reports for data extracts for your study.||Surveys are free. There is a $300 per project per year cost for a database project. There is a $90/hour charge for AIS to create forms or surveys for your study.|
|Training||AIS offers a variety of Velos training classes||In person with free consultation (60 minutes) offered by AIS; or online video training|
Deciding Between Data Management Tools
Does your study involve data entry from multiple sites?
- If using Velos and your study involves multiple sites performing data entry – you must issue a password to every data entry user.
- If using REDCap, you must either arrange to have all data entry performed at Stanford, or sponsor data coordinators at the non-UTSW sites for base-level UT Southwestern IDs.
Do you prefer to outsource your database development? Or stay in-house?
If you would like to design and build a database, Velos is your best option. If you have people on staff with the skills necessary to design and implement a study database, REDCap is your best choice.
Keep in mind that the time taken to actually field an operational system is largely determined by the complexity of the study. The time and resources required will typically be substantial, but will vary widely depending on the requirements of (and personnel involved with) the individual project. You should plan to include a budget line item in your grant to support database development.
Does your database need to integrate with clinical systems?
Neither REDCap nor Velos can integrate directly with clinical systems. Indirect integration in the form of one-time data extracts from clinical systems can be performed by our clinical research data warehouse team. This process is cumbersome and not well-suited to projects with ongoing integration needs. You may incur a charge for this service.
Is your study of indefinite or fixed duration?
If building a longitudinal registry (e.g., to track all patients seen in your department), Velos is your best choice – since it gives you the option of integrating with the clinical record. For a fixed duration study such as a clinical trial, use REDCap.
Do you need a study calendar?
Only Velos has a comprehensive study calendar for scheduling patient follow-up visits and calls. REDCap has relatively few features compared to Velos.
Do you need offline data entry?
You must have Internet access to enter data into Velos or REDCap. Both REDCap and Velos allow users to load data that was collected offline and print results.