Informatics Core
The GCRC offers Informatics services for investigators. The data management services are complementary to those offered in the Biostatistics Center and in the Division of Biomedical Informatics. Investigators are encouraged to determine their data management needs at the time they establish the statistical analysis needs for the project.
Data Management Consultation
We can facilitate use of the resources of CCHMC for data management for protocol projects.
Database Design - REDCap
Electronic Data Capture (EDC) for clinical research studies was identified as a top priority need by the Informatics Working Group of the NCRR/NIH (IWG) and by GCRC Informatics Core membership nationwide (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.
Over the past 3 years, Vanderbilt University (with collaboration from the University of Puerto Rico and the Medical College of Wisconsin) has developed a software toolset and workflow methodology (REDCap - Research Electronic Data Capture) to manage research data for small/medium (typical GCRC) 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 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 2-3 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.
Since August 2006 the existing software and workflow methods were freely shared in a consortium with other GCRC/RCMI/CTSA institutions. In this way, the project was used as a mechanism for studying and improving basic informatics collaboration among universities. Rather than charging money for the software to those institutions interested in REDCap, the centers that received and utilized the software were required to become a 'team member' and agreed to participate in further development or support of the project. Committed support by members of the consortium took on various forms (programming, technical support, documentation, testing, etc) and was deemed successful in terms of broadening the community base of users and support personnel and in furthering development of the REDCap project. CCHMC GCRC became active in the REDCap consortium in October 2007.
Is REDCap right for your Study?
You can see a demonstration of REDCap and get started working on your database before getting the protocol approved by GCRC. You can request REDCap even if you use no other resources of GCRC. However, your study must be submitted to the GCRC and approved before the database is made active. There is no charge for REDCap.
Contact Us
Contact Informatics Manager Catherine McGraw for more information, 513-636-8211 or Cathy.McGraw@cchmc.org.
