When discussing eSource there is as much detail to explore as any other segment of clinical trial operations. But from small biotechs to top 20 pharma, the starting point for discussions is more simple: how do we define eSource?
After numerous deployments of eBinders and eBinders eSource, we’ve come to understand that eSource is three things.
First, let’s set the groundwork with the FDA’s definition:
Common examples include, but are not limited to, clinical data initially recorded in electronic health records maintained by healthcare providers and institutions, electronic laboratory reports, digital medical images from devices, and electronic diaries completed by study subjects.
FDA regulations define an electronic record as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.5 An eCRF is an example of an electronic record.
We organize that definition into three practical categories:
The first step to a paperless trial is the regulatory binder at the site. How does this present itself? Electronic trial master files
(eTMF) have become commonplace among sponsors. This isn’t eSource. On the other hand, the study takes a meaningful step toward eSource when sites replace their investigator site file— all regulatory documents from CVs, to the protocol, to delegation logs and IRB comms— and make it paperless. This transition creates tremendous value for the site in:
- Reducing redundant tasks,
- Increasing compliance for all parties through reporting and frackers,
- Driving huge financial value for the sponsor in speed to startup, and preparedness for the 2017 eCTD mandate, and
- Enabling remote monitoring
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If we apply a crawl-walk-run analogy to defining eSource, eRegulatory is the crawl and Snapshots are the walk. With the right infrastructure, sites can capture the data and documents that are natively electronic in the study and turn them into source. For example, an eSource system with moderate sophistication enables the capture, filing, and if necessary, blinding / de-identifying of:
- Electronic health record (EHR) capture and filing
- Lab reports
- Device output
- Adverse event documentation
Yikes, sounds complicated. It used to be. What’s different today is that software has become succinctly sophisticated to make capture of key electronic source data like this easy for any site— all they need is a web browser and Internet access. What’s more is that through Snapshots, sites comfortable recording data into their EHR can stop right here— they can have 100% eSource operation by employing their EHR and a filing system that provides an audit trail.
If we’ve discussed the crawl and walk so far— this is the run. Bedside capture of eSource, outside of using the site’s EHR, requires adopting a digital input method in place of a case report form and a pen. There are three of forethought required when deploying Bedside eSource:
- Input: How will site users enter data? Will you ship tablets or provide something more familiar, like Microsoft Excel, on their PC?
- Compliance: How will that data be captured and managed to ensure HIPAA and 21CFR compliance?
- Output: Will the eSource platform offer full electronic data capture capabilities, or will it integrate with the EDC of choice?
Whereto from here? Now it becomes protocol-specific. In future posts we’ll discuss how Florence is rolling out solutions for specific protocol examples. For more information on how we can help your protocol, learn more about eBinders here