(1) eSource in clinical trials means eliminating the possibility for transcription errors.
(2) Data collected in Electronic Data Capture (EDC) systems is eSource.
Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.
FDA Guidance on eSource in Clinical Investigations
FDA defines eSource as *any* data initially recorded in electronic format. That’s a broad definition, one that includes:
a) equipment-generated data, such as digital imaging and labs
b) electronic Patient Reported Outcome (ePRO) transmissions
c) data streams from mobile health devices, such as Apple ResearchKit
d) data entered directly into an EDC, known as Direct-Data-Entry (DDE) solutions
e) data entered into an Electronic Health Record (EHR) or electronic Medical Record (EMR) system
Discussion of Direct-Data-Entry (DDE)
DDE systems allow research staff members to use portable devices to enter study data directly into an EDC system. DDEs have been garnering a lot of industry attention of late, and a number of companies offer solutions that offer a DDE data flow. As independent 3rd party auditors, we don’t want to play favorites by mentioning specific systems as examples, but if your company sells or uses a DDE system that you want to highlight, feel free to add a comment below to give it a shout out.
Discussion of EMR/EDC Integration
Not long after finalizing its e-Source guidance, FDA hosted a webinar that encouraged companies to explore direct EMR/EDC integration. While a few industry players have taken up the effort, movement has been slow. One difficulty: generally EMRs are built with healthcare in mind, not clinical research. Secondly, with so many EMR and EDC vendors, ensuring that EMR data from one system is mapped to appropriate EDC fields in another system relies heavily on data standards that are still being defined and need to be implemented on both sides.
Source Data Verification (SDV)
If data is transmitted directly from the source system to an Electronic Data Collection (EDC) system, SDV is not required, since the source data isn’t being transcribed manually. (Note: other types of Source Data Review (SDR) activities are still necessary, even if SDV isn’t. SDR must be conducted to verify ALCOA-C data principles such as attribution, originality, accuracy, completeness, etc.) Direct transmission from source system to EDC system is the typical pathway for items (a) – (d) above, and so SDV is not required for these types of eSource.
Common Confusions
SDV. Unless there is EMR/EDC integration – Item (e) above – source data from an EMR system needs to be manually transcribed. This is what makes T/F question #1 false. Just because source data originates in an EMR, it does *not* suggest SDV checks are superfluous. You could argue, as many have, that SDV is not a high-value activity and uncovers only a small percent of data error. That argument may well influence how much SDV is conducted, but whenever data is transcribed from original source into an EDC system, SDV is a relevant discussion.
EDC Data. It’s not unusual for someone to refer to data stored in EDCs as eSource. Data stored in EDCs are electronic, and may be source, but only if the EDC is the first place the data is recorded. This is what makes T/F question #2 false.
In Summary
If you’re ever in a discussion about eSource and things start going sideways, it may be time to haul out the formal definition of eSource -- in all its tedious detail -- to make sure everyone is using the term the same way.
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Image Credit: Paradox by Brett Jordan
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