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  2. 2022 (JAN-FEB) ELITE INSTITUTE OF PHARMA SKILLS SPECIAL ISSUE
  3. OVERVIEW ON CLINICAL DATA MANAGEMENT, HISTORY, TOOLS AND PROCESS
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Mr. Diptanshu Sandip Kasar 1, Ms.Archana Gawade2

OVERVIEW ON CLINICAL DATA MANAGEMENT, HISTORY, TOOLS AND PROCESS

CDM is Clinical data management from which we can get high quality, reliable, and statistically sound data from clinical trials. Overall time required for drug development to marketing is decrease by this process. Team member must be participated in every stage of this process. For maintenance of quality standards team members have required knowledge of the process. CDM procedure includes designing case report form , CRF annotation, designing of database, entry of data, data validation, management of discrepancy; medical coding, extraction of data and database locking are observed for quality at different interval of time during clinical trial. In current scenario raised demand to improve standards of CDM to fulfil requirements of regulatory authorities and stay ahead of competition by faster commercialization of product. These demands can be meeting by CDM team by implementing regulatory compliant data management tools. Submission of data electronically is also mandatory for companies. CDM professionals must fulfil appropriate expectations and fix standards for data quality.                                            KEYWORDS

Clinical trial, Clinical data management, Medical coding, Database locking, Discrepancy management, MedDRA