Standardize Operating procedure for Clinical Data Management (CDM), exploring the possibility under Indian Regulations

Abstract

With the advent of modifications in Indian regulations for clinical trials, there is the need to have standardization of individual clinical data management steps. This will not only have cost saving by mitigation of risk by avoiding data corruption but will help to evolve the Indian regulation towards globalization. This report shares the authors view based on experiences drawn by implementation of clinical trial data management procedures in an Indian biopharmaceutical company on vaccine trails.