032-2008: Clinical-Data Acceptance Testing …

1 Paper 032-2008 Clinical-Data Acceptance Testing Procedure Sunil Gupta, Quintiles, Thousand Oaks, CA ABSTRACT In the pharmaceutical industry, there is a regulatory responsibility, 21 CFR Part 11, to analyze only the clinical data that has passed data Acceptance Testing or is considered clean data after a database lock. clinical data Acceptance Testing procedure involves confirming the validity of critical data variables. These critical data variables might need to be non-missing, consist only of valid values, be within a range, or be consistent with other variables. If incorrect clinical data is analyzed, then invalid study conclusions can be drawn about the drug s safety and efficacy. In 2001, the data Warehousing Institute conducted a survey of over 600 business professionals. Across all industries, the survey results estimate that data quality problems cost corporations more than $ 600 billion per year. Proactive steps need to be taken to identify, isolate and report clinical data issues using a system that is flexible, easy to update and facilitates good communication with the clinical data Management (CDM) department to help resolve these data quality problems.

Feb 04, 2008 · 1 Paper 032-2008 Clinical-Data Acceptance Testing Procedure Sunil Gupta, Quintiles, Thousand Oaks, CA ABSTRACT In the pharmaceutical industry, there is a regulatory responsibility, 21 CFR Part 11, to analyze only the clinical data

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  Data, Testing, Clinical, Procedures, Acceptance, Clinical data acceptance testing, Clinical data acceptance testing procedure

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