Pharmacoéconomie : accès libre

Effective Data Cleaning and Validation Strategies in Clinical Data Management

Abstract

Rainer Rilke

Clinical Data Management (CDM) plays a pivotal role in the healthcare industry, ensuring the integrity and accuracy of data collected during clinical trials and studies. Clean and validated data is not just a regulatory requirement; it is essential for drawing meaningful conclusions, making informed decisions, and ensuring patient safety. In this article, we will delve into the world of data cleaning and validation in clinical data management, exploring why it is crucial, the challenges involved, and effective strategies to ensure data quality. Clinical trials, patient safety is of utmost importance. Inaccurate or incomplete data can lead to incorrect conclusions about a drug's safety or efficacy, potentially putting patients at risk. Regulatory bodies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate rigorous data standards to ensure the quality and integrity of clinical trial data. Non-compliance can lead to regulatory action and delays in product approvals. Regulatory bodies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate rigorous data standards to ensure the quality and integrity of clinical trial data. Non-compliance can lead to regulatory action and delays in product approvals.