Remote source document verification (rSDV): Our patented system to create network-accessible certified source-document copies relieves the clinical monitor/auditor from having to go on site to view physical copies of source documents. Instead, source-document verification can be done at a centralized location using images of the paper documents created using the TheraScan system — which uses a standard personal computer and document scanner. This is at a cost near that of a standard photocopy or facsimile.
Certified copy of Electronic Health Record screen
Electronic certified copies can be used in lieu of an orginal for source document verification. Integration with electronic data capture systems is as simple as adding a field to hold the TheraScan ID which links the data record to the source document.
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Electronic files can also be copied and certified with the TheraScan system. This opens the possibility of certifying output from imaging systems, web archives/screen shots from EMR systems, or clinical flowsheets retained as spreadsheets.
When combined with an EDC system, network-accessible source documents greatly simplify risk-based monitoring by having the source documents available concurrently with EDC data. EDC systems do not require customization in order to incorporate rSDV into the process.
As protected health information (PHI) can be included in the source documents, it is necessary that patients consent to appropriate monitors having permission to view source documents.
Other that monitors, only the site staff have the ability to view the content of source documents. Each viewing is logged in the system. The only other source data may be viewed is in the case of a severe adverse event. In this case only information specifically uploaded for the event may be views by the study director as well as the sponsor’s medical director.