Choosing a Data Management System for Research

Academic Information System current offers two research data capture development solutions, both of which are recommended over the more traditional choice of Excel, Access and FileMaker, since they both satisfy the HIPAA Privacy Rule requirements, while traditional software is much hard to use in a compliant fashion.

The Velos Clinical Trials Management System is designed to aid with patient recruitment, protocol management, budgeting and financials, electronica data capture, data safety monitoring, adverse event reporting and patient calendaring. This system offers interfaces to both EPIC and eIRB thus eliminating redundant entry in multiple systems. Velos should be used for FDA governed clinical trials. Velos requires consulting with the Research Data Management Group to efficiently plan your study.

REDCap is a Research Data Capture system originally designed at Vanderbilt but now being used at more than 307 institutions worldwide including here at UT Southwestern This is a self-service system, where 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, you can start entering data immediately. AIS offers support during the process of defining and refining your database.

Deciding which tool to use

Does your study involve data entry from multiple sites?

If your study involves multiple sites performing data entry, you issue every data entry person a password-protected login if using Velos. If using REDCap you must either arrange to have all data entry performed at Stanford, or sponsor the data coordinators at the non-UTSW sites for base-level Southwestern ID's. View more information on UT Southwestern User Access.

Do you prefer to outsource your database development or keep it in-house?

If you want Academic Information Systems to design and build a database for you, 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 choices.

When planning a study database you need to bear 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 also plan on including a budget line item in your grant to support database development.

Do you have any integration needs with clinical systems?

Neither REDCap nor Velos have the ability to integrate directly with the clinical systems at this time. Indirect integration in the form of one-time data extracts from clinical systems are possible through our clinical research data warehouse team, but 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. If you are running a fixed duration study such as a clinical trial, you should be fine with REDCap.

Do you need a study calendar?

Only Velos come with 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 access to the internet to enter data into Velos or REDCap. Both offer the capability to make  paper printout. REDCap and Velos both allow the user to load data that was collected offline.