The Electronic Source Data in Clinical Investigations guidance document (FDA, 2013) defines eSource as “data initially recorded in electronic format.” The paper goes on to state, “this guidance promotes capturing source data in electronic form,” and eSource should “encourage entering source data during a subject visit… facilitate remote monitoring of data… [and] promote real-time access for data review.”
Thus, eSource is simply digitized source data that can originate from many possible sources:
- Sites entering data directly into an electronic data capture (EDC) system or EMR/EHR.
- EDC systems importing data directly from a laboratory system.
- Patients filling out an ePRO form on a mobile device.
- Physiological data being collected from a wearable sensor.
Since 2010, regulatory authorities worldwide have provided guidance on their expectations for using eSource in clinical trials (e.g., EMA, 2010 and 2019; FDA, 2013; MHRA, 2015; PMDA, 2015). Digital initiatives and guidance documents collectively suggest that eSource will play an increasingly important role in the future of clinical trials and in supporting regulatory submissions. For instance, in their draft guidance on heart failure, the FDA explicitly discussed the use of accelerometry data as a novel endpoint that will be considered a measure of heart failure and used to assess treatment effects (FDA, 2019).