Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.
BACKGROUND
Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process.


RESULTS
The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task).


CONCLUSIONS
The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.
Pietrobon
Ricardo
R
Center for Excellence in Surgical Outcomes, Division of Orthopaedic Surgery, Duke University Medical Center, Box 3094, Durham, NC 27710, USA. rpietro@duke.edu
Shah
Anand
A
Kuo
Paul
P
Harker
Matthew
M
McCready
Mariana
M
Butler
Christeen
C
Martins
Henrique
H
Moorman
C T
CT
Jacobs
Danny O
DO
D000046:Academic Medical Centers / Q000191:economics / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence*; D002985:Clinical Protocols; D003628:Database Management Systems; D028744:Ethics Committees, Research; D033161:Government Regulation; D019983:Guideline Adherence / Q000191:economics; D017721:Hospital Costs; D006801:Humans; D016490:Integrated Advanced Information Management Systems; D020407:Internet; D009657:North Carolina; D019982:Organizational Case Studies; D011381:Programming Languages; D013503:Surgery Department, Hospital / Q000331:legislation & jurisprudence