Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Priya Nair, Vikram Singh

ABSTRACT: Quality assurance (QA) in clinical data management and documentation is critical to ensure the integrity, reliability, and regulatory compliance of clinical trials. Accurate, complete, and consistent data support decision making for drug development, safety assessments, and regulatory submissions. This paper explores QA strategies in clinical data management, focusing on data validation, monitoring, audit trails, and regulatory adherence. Tables illustrate QA processes, documentation standards, and common errors with mitigation approaches. Challenges such as human errors, technological limitations, and regulatory complexities are addressed. Emphasis is placed on implementing robust QA frameworks, electronic data capture systems, staff training, and continuous monitoring to enhance data quality and reliability in clinical research.

KEYWORDS: Quality Assurance, Clinical Data Management, Documentation, Regulatory Compliance, Data Validation, Audit Trails, Electronic Data Capture.