Validating electronic source data clinical trials


One of the goals of monitoring of clinical trials is to have accurate data for the analysis of efficacy and safety.Historically, clinical trial data were collected at the clinical research site on pieces of paper designated as Source Documents.It is rare for the clinical trials industry to spend time and money on a tedious and labor intensive process when it is not required by the U. The high cost of source data verification (SDV), particularly in large trials, has made it a target of scrutiny over the last decade.In addition, the positive impact (ie, cost-benefit ratio of SDV) on overall data quality is often questioned.As a result, regulators and industry groups have started looking at alternative SDV approaches.Oversight of the clinical trials includes clinical research, data management, biostatistics, project management, regulatory and quality assurance.It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant.


In 2010, the European Medicines Agency (EMA) issued a “Reflection Paper Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials,” and in 2013, the United States Food and Drug Administration (FDA) issued the “Guidance for Industry: Electronic Source Data in Clinical Investigations”.

Those of us in the healthcare trenches, whether physicians, patients, employers, payers or government officials, can easi Iy be forgiven for having more than a dollop of cynicism about the current enthusiasm about the adoption of EMRs.


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