Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work. All researchers try their hands on CDM activities during their research work, knowingly or unknowingly. Often research students ask the question, “what is Clinical Data Management (CDM) and what is its significance?” Clinical data management is a relevant and important part of a clinical trial. The quality of data generated plays an important role in the outcome of the study. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.Ĭlinical trial is intended to find answers to the research question by means of generating data for proving or disproving a hypothesis. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. Additionally, it is becoming mandatory for companies to submit the data electronically. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion.

This helps to produce a drastic reduction in time from drug development to marketing.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

Data dredging in clinical trials