What is it about?
In the clinical trial process, precise and concise data collection at the source is imperative to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs CDASH provides guidance to develop the case report form (CRF), a data collection tool for domains that are commonly used for the majority of the clinical trials across the therapeutic areas.
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Why is it important?
Provided history of CDASH and its implementation with examples in clinical research industry. The benefits illustrated in the article were more closer to reality and based on Author's vast experience in different organizations.
Perspectives
Pharma companies spend more money on following their own standards while developing the CRFs and designing the databases in the EDC/CDMS tools. This approach again needs data conversion techniques for regulatory submissions. As a common goal, it is highly recommended to initiate and implement the CDISC standardization path that provides the benefits of cost, time and high accuracy of data. At the same time, CDASH standards act as a catalyst to reduce the turnaround time for the review process and helps companies to launch drugs in the markets. In the case of orphan drugs and fast track drugs, the implementation of standards is imperative in reducing the time required in bringing the drug to the market.
Mr Jagadeeswara Rao Gaddale
Tata Consultancy Services
Read the Original
This page is a summary of: Clinical data acquisition standards harmonization importance and benefits in clinical data management, Perspectives in Clinical Research, January 2015, Medknow,
DOI: 10.4103/2229-3485.167101.
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