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Year : 2015  |  Volume : 6  |  Issue : 4  |  Page : 179-183

Clinical data acquisition standards harmonization importance and benefits in clinical data management

Domain Consultant, Life Sciences, Tata Consultancy Services, Mumbai, Maharashtra, India

Correspondence Address:
Jagadeeswara Rao Gaddale
S-2, Brundavana Apartments, 2nd Cross, Patellappa Layout, Nagashettyhalli, Bengaluru - 560 094, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.167101

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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.

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