Site-level Quality Assurance Outcome: Identification of Sponsor-provided Source Documents With Greatest Prevalence of Errors

Time

Tue, Jun 25 11:45AM
T 03

Title

Site-level Quality Assurance Outcome: Identification of Sponsor-provided Source Documents With Greatest Prevalence of Errors

Abstract Summary

Case files of a 24-wk outpatient study source pages examined for corrections required. Pages were either: error-free, needed self-evident corrections (SEC) or non-self-evident corrections (NSEC). NSEC either met (NSEC-met) or failed (NSEC-fail) GCP. Additional methodology is provided in the poster.

Poster Presenter

Patrick G. Clay
PharmD,
Professor,
University of North Texas
United States

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