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Remote Source Document Verification (rSDV)

The Cost Effective Alternative to Traditional Trial Monitoring


What will you learn in this eBook?

Remote Source Document Verification (rSDV) is a relatively new practice. This ebook will explain its definition, present explored and piloted practices of conducting rSDV, discuss the shortcomings of traditional monitoring and 100% SDV, and showcase the cost savings that can be incurred, as well as process efficiencies compared to traditional trial monitoring when using an rSDV approach. You will learn how rSDV offers the best alternatives to ensure both the quality of the trial while providing appropriate oversight to safeguard the rights and wellbeing of trial participants.


Benefits of rSDV presented in this ebook include: 

  • Quality - Site issues are identified within days or weeks rather than months. This protects research subjects as the Sponsor is able to pinpoint issues and initiate remediation plans immediately.
  • Speed  - The entire data access and review process for any patient visit can be complete within one week after a subject is seen at site.
  • Cost - Remote SDV reduces trial budget in many areas. The first and most obvious saving pertains to the frequency and costs associated with a clinical research associate travelling to research sites to conduct site monitoring visits.
  • Site Interactions - A survey of 115 sites that had completed a Phase III study with remote SDV revealed that the sites were very accepting of remote SDV. When asked about their favourite feature, many cited that they preferred the rapid feedback on their activities. It enables them to “close out” a subject’s visit when it is still fresh in their minds.


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