Web-Based Case Report Form Design for Clinical Trial

Ling Li Fu; Tao Chen

doi:10.4028/www.scientific.net/AMM.39.19

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HomeApplied Mechanics and MaterialsApplied Mechanics and Materials Vol. 39Web-Based Case Report Form Design for Clinical...

Web-Based Case Report Form Design for Clinical Trial

Abstract:

With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.

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Periodical:

Applied Mechanics and Materials (Volume 39)

Pages:

19-24

DOI:

https://doi.org/10.4028/www.scientific.net/AMM.39.19

Citation:

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Online since:

November 2010

Authors:

Ling Li Fu, Tao Chen

Keywords:

Clinical Data Management, Electronic Case Report Form, Electronic Data Capture

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References

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[2] Frederic P. Miller, Aqnes F. Vandome and John McBrewster: Clinical data acquisition: clinical trial. Electronic data capture, case report form, good clinical practice, clinical data interchange standards consortium, clinical data management system, Alphascript publishing (2010).

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[4] Information on http: /www. cdisc. org/models/odm/v1. 3/ODM1-3-0-Final. html.

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[5] Lingli Fu, Sheng Ding and Tao Chen, in: Clinical data management system in International Conference on Biomedical Engineering and Computer Science (ICBECS 2010), Wuhan, China (2010), pp.1-4.

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