SOURCE: Xtalks

Xtalks Webinars

November 16, 2016 07:00 ET

Implementation, Evolution and Change Management Required for Remote Source Data Verification (rSDV), New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - November 16, 2016) - Dr. Gavin H. R. Boodoo, Remote Clinical Data Monitoring (RCDM) Manager at Quanticate, will walk the audience through how implementation, evolution and change management are critical for a successful remote monitoring program. He will also be outlining how a remote monitoring program harmonizes with current SDV practices. The live event will take place on Tuesday, November 29th, 2016 at 11am EST (4pm GMT/UK).

Source Data Verification (SDV) is a fundamentally non-value added activity. It is a quality control step that fails to produce quality but seeks to test the quality of the data, an approach widely recognized as being inefficient and ineffective. As a non-value added activity, it should be a prime target for cost reduction while at the same time sustaining and increasing the integrity of clinical data with the source records on site. Recently, the pendulum has swung from 100% non-discriminating SDV to extremely low levels. An example of a Sponsor's reduced algorithm for a post marketing study significantly reduced the amount of data items under review and focused primarily on data.

The Sponsor set monitoring guidelines at 10% of sites and 28% of data points at sites (= 2.8% of all data review). Not because statistical or "reduced" Source Data Verification was better practice or science, or because a magic algorithm was found that could assure quality of data points not verified, but primarily to reduce cost and reduce the occurrence and duration of monitoring visits.

Remote Source Data Verification (rSDV) is a well-­‐defined task within our industry by Sponsors, vendors and sites, but is a relatively new practice that due to its infancy has a multitude of definitions and applications. The practices proposed, explored and piloted, range from reviewing fax transmitted source documents to video recording and archiving patient visits. The term remote Source Data Verification needs to be both defined and standardized across the industry to create a common and targeted dialog that explores the impact of different practices and technologies on both cost and achievable data integrity.

This webinar will cover the innate weaknesses of onsite monitoring, advantages of remote monitoring/rSDV which includes the increased accuracy of data, reduced time to submission, how there can be more focus to enhance CRA activities, the cost savings that occur and improved patient recruitment. We will also look at the internal change management required, advantages of rSDV to fulfill ICH E6 addendum and new job functions required.

To learn more about this event visit: Implementation, Evolution and Change Management Required for Remote Source Data Verification (rSDV)

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