ROLE OF CLINICAL DATA MANAGEMENT SYSTEM: CLINICAL RESEARCH MONITORING TOOL IN MULTI-CENTRE CLINICAL TRAIL
Multidisciplinary co-operation in multi trail Centre need an organized data management, configuring to ensure true progress monitoring and high-quality research data. So, that CLINICAL DATA MANAGEMENT (CDM) is an essential tool in the medical study, leads to produce high –quality, reliable and statically significant data from multiple clinical trials and diminish time phase of drug development to marketing. CDM’s members are extremely active during all stages of clinical trial or drug development, from inception to completion and maintain the quality standards of CDM process on the other hand, multiple procedure in CDM, including Case Report Form (CRF) designing, CRF annotation, database designing, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular interval during a multi centric clinical trial. Presently, CDM is becoming compulsory for drug development companies to submit data electronically. This review article spotlight on the process involved and provide the reader on overview of the tool & Elements of CDM, Data management’s tools as well as the role and responsibilities in CDM .
KEYWORDS: Clinical Data Management, Elements of CDM, Data Management Tools, Data Storage, Scope Responsibility of CDM, Importance of CDM.