Abstract

A SHORT REVIEW ON CLINICAL DATA MANAGEMENT

Sandeep Goud Mitta*, Bandari Chandana, Manda Snehanjali, Mothe Paidi, Abdul Karim, Arelli Sukanya and Katnam Shylaja

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Abstract

Clinical Data Management (CDM) is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. It is a vital phase in clinical research, which leads to establishment of high quality, consistent, and statistically significant data from clinical trials. Research that examines novel diagnostic procedures and therapeutic approaches and assesses their impact on human health outcomes is known as clinical trials.[1] An important factor in the study's outcome is the kind and Caliber of the clinical data. A Clinical Data Management (CDM) system is required for the research's verification since the clinical data that has been acquired is properly maintained to produce correct clinical study results. Clinical research has become impossible without the use of Clinical Data Management Systems to handle the increasing amount of data that must be collected, processed and analysed for clinical trials. There are many steps involved in the data management such as- collection, cleaning, and organize or management of all subject data in compliance with regulatory standards. CDM team evaluates all discrepancies in database at regular intervals to make sure that they have been resolved.

Keywords: Clinical data management, Clinical Research, Discrepancy, regulatory standards.