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Risk-Based Source Data Verification Approaches: Pros and Cons

November 1, 2010

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Data Services

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Article

The high cost of source data verification (SDV), particularly in large trials, has made it a target of scrutiny over the last decade. In addition, the positive impact (ie, cost-benefit ratio of SDV) on overall data quality is often questioned. As a result, regulators and industry groups have started looking at alternative SDV approaches. 

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Drug Information Journal
Vadim Tantsyura, Imogene Grimes, Jules Mitchel, Kaye Fendt, Sergiy Sirichenko, Joel Waters, Jim Crowe, Barbara Tardiff
November 1, 2010
http://www.diaglobal.org/resources/publications

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