Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Jun;29(6):337-43.
doi: 10.1097/NCN.0b013e3181fcbc95.

Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults

Beverly S Musick  1 , Sheri L Robb, Debra S Burns, Kristin Stegenga, Ming Yan, Kathy J McCorkle, Joan E Haase
Affiliations

Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults

Beverly S Musick et al. Comput Inform Nurs. 2011 Jun.

Abstract

Recent advances in technology provide support for multisite, Web-based data-entry systems and the storage of data in a centralized location, resulting in immediate access to data for investigators, reduced participant burden and human entry error, and improved integrity of clinical trial data. The purpose of this article was to describe the development of a comprehensive, Web-based data management system for a multisite randomized behavioral intervention trial. Strategies used to create this study-specific data management system included interdisciplinary collaboration, design mapping, feasibility assessments, and input from an advisory board of former patients with characteristics similar to the targeted population. The resulting data management system and development strategies provide a template for other behavioral intervention studies.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Process of Designing Data Collection Forms
Figure 2
Figure 2
Process of Developing the User Interface
Figure 3
Figure 3
Participant Questionnaire
Figure 4
Figure 4
Face Page for Entry to Study Activities by Participant. User’s Role Determines Access
Figure 5
Figure 5
Sample of Real-Time Report: Recruitment Report
See this image and copyright information in PMC

References

    1. Welker JA. Implementation of electronic data capture systems: barriers and solutions. Contemporary Clinical Trials. 2007 May;28(3):329–336. - PubMed
    1. Marks RG. Validating electronic source data in clinical trials. Controlled Clinical Trials. 2004 Oct;25(5):437–446. - PubMed
    1. Kennedy C, Charlesworth A, Chen JL. Interactive data collection: benefits of integrating new media into pediatric research. Computers, Informatics, Nursing: CIN. 2003 May-Jun;21(3):120–127. - PubMed
    1. Rivera ML, Donnelly J, Parry BA, et al. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department. BMC Medical Informatics & Decision Making. 2008;8:3. - PMC - PubMed
    1. Weber BA, Yarandi H, Rowe MA, Weber JP. A comparison study: paper-based versus web-based data collection and management. Applied Nursing Research: ANR. 2005 Aug;18(3):182–185. - PubMed

LinkOut - more resources