Abstract:

Clinical data management helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM including case report form (CRF) designing, CRF annotation, data designing, data-entry, data validation, discrepancy management, medical coding, data extraction and data locking are assessed for quality at regular intervals during the trial. Presently there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory complaint data management tools. CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit data electronically. It is advocated that CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. Pls refer Binny Krishnankutty, Shantala Bellary, Naveen B. R. Kumar et al 2011 Data management in clinical research an overview Indian Journal of pharmacology 44(2):168-172. doi 10. 4103/0253-7613.93842 

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