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Review
. 2015 Oct-Dec;6(4):179-83.
doi: 10.4103/2229-3485.167101.

Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management

Jagadeeswara Rao Gaddale  1
Affiliations
Review

Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management

Jagadeeswara Rao Gaddale. Perspect Clin Res. 2015 Oct-Dec.

Abstract

In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.

Keywords: Clinical Data Acquisition Standards Harmonization; Study Data Tabulation Model; clinical data interchange standards consortium; data standards.

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Figures

Figure 1
Figure 1
CDASH standard domains
Figure 2
Figure 2
Traditional case report form for inclusion and exclusion criteria
Figure 3
Figure 3
Traditional physical examination page
See this image and copyright information in PMC

References

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    1. Linger RS. Implementing CDASH Standards into Data Collection and Database Design. [Last accessed 2015 Jun 2]. Available from: http://www.portal.cdisc.org/CDISC20User20Networks/North20America/Bay20Ar... .