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.
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:
- 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
- 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.
- 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?
Pubget, Microsoft, BCG, University of California-Berkeley, Dartmouth College
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