Investigation of inferencing and implementation of standardized cdm protocols as per Indian GCP guidelines

Clinical Data Management (CDM) is a cornerstone of clinical research, ensuring the accuracy, reliability, and regulatory compliance of data collected in clinical trials. This dissertation investigates the development, implementation, and standardization of CDM protocols specifically tailored to align with Indian Good Clinical Practice (GCP) guidelines, with a focus on vaccine trials conducted in India. The study emphasizes the lack of detailed procedural guidelines in Indian regulations and addresses the resulting variability and compliance risks in CDM practices. Through an industry survey and practical case studies involving Myfive™ and NUCOVAC® vaccine trials at Panacea Biotec Ltd., the research defines a step-wise CDM model grounded in GCP principles. The proposed model was validated through audits and replicated to ensure procedural standardization, data quality, and regulatory acceptance. Key CDM activities such as CRF design, data validation, discrepancy management, and audit trail maintenance were optimized. The study concludes that standardized CDM practices significantly enhance operational efficiency, reduce compliance risks, and facilitate smoother regulatory submissions, marking a strategic advancement for the Indian pharmaceutical and vaccine research industry.