Validating electronic source data clinical trials
A major publication by CTTI of monitoring practices has helped to transform the monitoring of clinical trials.
According to the Food and Drug Administration (FDA) e Source Guidance of 2013: “Electronic source data are data initially recorded in electronic format.
An acceptable amount of delay should be defined and justified prior to trial recruitment.
The source data and their respective capture methods should be clearly defined prior to trial recruitment (i.e., in the protocol or study-specific source data agreement).
Perhaps failure to appreciate the wisdom contained in the quotes below explains why those doing clinical research spend a lot of their time on non-productive activities.
There is broad agreement across the pharmaceutical industry that it no longer makes sense to collect clinical trial data by writing results and observations first on a piece of paper, then to transcribe those data into an EDC system, and then to save that paper so that a clinical research associate (CRA) can check how precisely a person transcribed information from a piece of paper into the EDC system.
Even earlier, however, in 2010, the EMA GCP Inspectors Working Group e Source subteam released the “EMA Reflection Paper On Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials.” The reflection paper—which is very similar in nature to an FDA guidance—was followed up by direct exchanges with industry representatives (the Society for Clinical Data Management and the e Clinical Forum, among others).
If this is not possible the chronology of events should be recorded.
Figure 1: The Problem There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.