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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SCRS responded on behalf of its almost 300 site members from over 12 countries with the site's perspective on the two recently issued FDA Draft Guidance Documents: Guidance for IRBs, Clinical Investigators and Sponsors IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed &; Guidance for Industry: Electronic Source Data in Clinical Investigations.
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.
The clinical trial is an observational study in up to 400 subjects that are admitted to various ICU wards and comes on the heels of FDA's draft guidance on "Electronic Source Documentation in Clinical Investigations," and the European Medicines Agency (EMA) "Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials.
With the ability to combine both paper source and electronic source data into one seamless database, esi Specialists will deliver processed electronic data to any software or platform its clients specify.
Dave is co-lead of the CDISC electronic Source Data Interchange (eSDI) group that is working with the Food and Drug Administration (FDA), examining the difficult topic of electronic source documents and data.
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