Abstract

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A PERSPECTIVE OF CLINICAL DATA MANAGEMENT IN THE CONTEXT OF THE APPLICATION OF INDIAN GOOD CLINICAL PRACTICES

Bajpai N, Chatterjee A, Dang S, Sharma SK


The focus of this article is on the areas wherein the Indian GCP (Good clinical Practice) interface core themes of Clinical Data Management (CDM). In particular, it highlights evolving trends in CDM and emphasizes the increased necessity to focus on data from a regulatory requirements perspective. To this end, contemplations with respect to CDM activities in context of Indian GCP are reported.