eSource data

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eSource data

In a clinical trial, source data that is captured initially into a permanent electronic record used for the construction and evaluation of a clinical study. Any changes made in a permanent record can be assessed via an audit trail.

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eSource document

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Vault EDC can be deployed as a standalone application or integrated electronic source data (eSource) with Vault eSource to record patient data directly into a mobile application.

Veeva Systems expands EDC and eSource

The accumulation of electronic source data and the evolution of electronic documents toward more dynamic forms that can combine written text, bookmarks, hyperlinks, and multimedia features create the need for digital archives and electronic signatures to preserve the integrity of originals.

Digital archiving in the pharmaceutical industry: while relatively new as a retention method in the drug industry, e-archiving of records is a must-do to best ensure the health of patients and the industry

As information is saved, its electronic source data is captured and stored all in the same step.

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While dragging and dropping the eGems into storage, students automatically capture the eGems' electronic source data and store it in the same step.

Gemteq Software Introduces New Research Tool

If clinical patient data was collected only as electronic source data, it would be possible to integrate that data into an EMR using healthcare interoperability standards such as Health Level Seven (HL7) data export or, alternatively, printing the electronic source data and add it to the patient's medical record.

The promise of EDC: how soon is now?

Food and Drug Administration (FDA or Agency) released a draft procedural guidance document relating to the conduct of clinical trials regarding electronic source data in clinical investigations that is intended to enhance the reliability, quality, integrity, and traceability of electronic source data.

Electronic source data are a subset of source data: those that were initially recorded electronically.

Electronic data in clinical investigations: FDA revises draft guidance document to address industry comments