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REDCap Project Summary
Electronic Data Capture (EDC) for clinical research studies has been identified
as a top priority need by IWG and AGITP membership (through survey and GCRC annual
meeting engagement). Although clinical trials software exists, most are geared
around the business or project-management side of studies, rather than raw data
capture and dissemination. Commercial EDC software is expensive from both a
monetary cost and time to initiate and manage case report forms for individual
studies. Several open-source EDC products are available, but appear also to be
costly from a time commitment standpoint, especially when running multiple,
concurrent studies.
Vanderbilt University (with collaboration from many other institutions)
has developed a software toolset and workflow methodology (REDCap - Research Electronic Data Capture)
to manage research data for research studies. The software is easy to
implement on a study-by-study basis and depends on a solid data dictionary
(metadata) to eliminate virtually all requirements for programming. The
resulting product is a secure, web-based application that is flexible enough to
be used for any type of research, provides an intuitive interface for users to
enter validated data, and an export mechanism for end-of-study export of data to
common statistical packages (SPSS, SAS, Stata, R/S-Plus). The workflow
methodology developed for collecting the required study metadata consists of
an initial 1-hour meeting with research teams for training and occasional
interaction to build software prototypes based on provided data. Once the
web-based data repository is built, researchers are encouraged to iteratively
review and correct the data dictionary until completed, at which time the study
is placed in production or 'live' status. An estimate of the total time
investment by informatics personnel (including training, prototype and
production mode builds) for a typical study is 1.5 hours. Researcher teams
spend an average of 9 hours in the iterative development of the final data
dictionary used to run the study. In addition to providing a useful and
secure electronic tool for data collection and dissemination, researchers
report that the iterative and collaborative development of the study case
report forms is a very useful part of the workflow methodology in supporting
their scientific projects.
We initiated a consortium project around REDCap in August, 2006 and have since shared
the software and methodology with a larger research community of CTSA, GCRC and RCMI institutions.
The consortium is open to any academic institution, and members are provided software and support at no
charge with the expectation that participants will contribute back to the overall project.
© REDCap Software - Vanderbilt University Medical Center - 2008
