REDCap data capture system pulls heavy weight for CTs

Free application is easy to use

One of the technological advances resulting from the National Institutes of Health's (NIH's) Clinical Translational and Science Awards (CTSA) project is a stream-lined, flexible, and interoperable data capture system called the REDCap (Research Electronic Data Capture).

More than 4,500 studies now use REDCap, and the REDCap Consortium includes 171 institutional partners. REDCap has a second web-based application called REDCap Survey, as well.

REDCap is a federally-funded project that provides code and technical support to nonprofit institutions or academic institutions that join the consortium.

Developed at Vanderbilt University in Nashville, TN, REDCap has received CTSA funding and is disseminated at no charge to consortium members, says Janey Wang, MS, MEng, project manager for the REDCap Project at Vanderbilt.

"What's nice about REDCap is it is a very simple data capture system that can be used for anything," Wang says. "You don't have to have a very fully finalized data collection instrument before you use REDCap."

All investigators need to do is think through data types and data elements they plan to collect.

"We're trying to empower researchers to be more [proactive] with data management," Wang explains. "REDCap saves them the cost of hiring additional personnel or constantly consulting a data management team."

New investigators can use REDCap for free, so long as they know which data elements they want to collect and can monitor these.

"The learning curve is not high, and we provide a lot of materials and resources for end users to explore REDCap on their own," Wang says. "Researchers find it's easy to learn in a cost-efficient way."

Here are some of REDCap's features:

• Retrospective and prospective data collection: REDCap has been used for clinical research, collecting everything from demographics and medical history to use in pilot trials and retrospective studies.

The application can extract data from medical records and restructure these in ways that are useful to investigators, Wang says.

"It has the capability to reduce data entry forms multiple times and put these in longitudinal format so end users define their studies' scheduled events along REDCap, as in baseline, visit 1, visit 2, etc.," Wang explains.

"Then it can create data entry forms for the study and designate which form they want to use at multiple times," she says. "If they have an adverse event form defined for their study, then they can use it for all events where they want follow-up."

REDCap can collect adverse event data without requiring every field to have an entry every time. This makes it more flexible for clinical trial use, she adds.

• Data transfer system: One of REDCap's most useful features is it's interoperability with electronic medical record (EMR) systems.

"If an investigator has some patients in the EMR repository and wants to pull out those data from the EMR, then REDCap can assist with this," Wang says.

This interoperability is being tested at Vanderbilt and four other academic research sites, Wang says.

"Each has a different EMR system, but we wrote the program to be flexible enough to allow interoperability," she adds. "It's being optimized in our shop to make sure we can accommodate the different systems out there."

It's challenging to use different EMR systems, but there is a huge need for this flexibility among researchers because it can save them a lot of time on data collection and input, Wang notes.

"You can pull data from the EMR on lab results, combined criteria, and it saves a lot of time," she says.

• Data instrument share library: The REDCap consortium website at www.project-redcap.org contains a library with a variety of validated study instruments that investigators can use.

One includes the Rand 36 Item SF Health Survey Instrument (Version 1.0), which is a short form for collecting quality of life data. Other instruments featured in the library are as follows:

— Ten-Item Personality Inventory-(TIPI).

— PROMIS Emotional Distress - Depression - Short Form 8b.

— Pittsburgh Sleep Quality Index (PSQI).

— Geriatric Depression Scale GDS Short Form.

— BRFSS 2009 Section 3: Health Care Access.

"Once investigators identify the correct instrument they want to use, they can import it into REDCap, and they won't have to develop a data entry form because it already exists," Wang says.

Researchers simply have to define the field and make sure the data entry form includes all the questions necessary and in the correct order, she adds.

"In a way, we're advocating the concept of using standardized instruments and standardized vocabulary and conventions for data elements," she adds. "Once data are exported they can change it freely, and the values are stored the same way."

This particular resource will continue to grow and increase in value to researchers as more instruments are added to the library, Wang says.

• Technical support: "The REDCap consortium is a very active group of people who are knowledgeable in terms of informatics, and they share information with others," Wang says.

Any technical problems sites have with REDCap can be answered through an archive of discussions or by members of the consortium.

"We don't have a team at Vanderbilt, so a lot of technical support is done by the consortium itself on a voluntary basis," Wang says. "Newcomers mostly feel it's well supported, and they are able to get feedback very quickly."