Clinical trials are intended to find answers to research questions by means of generating data for proving or disproving hypotheses. Clinical Data Management (CDM) is critical to the generation of high-quality, reliable, statistically sound data from clinical trials and thus plays a central role in the outcome of trials.
When done well, CDM greatly helps improve the efficiencies of clinical research, reducing both the time and cost of taking medicines from bench to market. The CDM process, like a clinical trial, begins with the end in mind.
CDM personnel are actively involved in all stages of clinical trials from inception to completion. They require adequate process understanding and knowledge to help maintain the quality standards of data management activities.
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 clinical trial.
In today’s global regulatory environment, there is an increasing demand to continually improve CDM standards to ensure regulatory requirements are met. In regulatory submission studies, maintaining an audit trail of data management activities is of paramount importance.
CDM tools are available to ensure the audit trail and help in the management of any data discrepancies. These tools, along with the records they produce, have to comply with Title 21 (Food and Drugs) of the Code of Federal Regulations (CFR), Part 11 (electronic records and signatures), or more commonly, 21 CFR Part 11.
CDM has evolved in recent time in response to the ever-increasing demand from biopharmaceutical companies to fast-track the drug development process whilst ensuring quality systems are in place to generate high-quality data necessary for the regulators and their evaluation processes.
CDM has become a specialty in its own right and is inexorably intertwined with the clinical trial process.
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This article was written by Ric DeGaris from our Clinical Development team.