Transcription of 032-2008: Clinical-Data Acceptance Testing Procedure
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032-2008: Clinical-Data Acceptance Testing Procedure
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.
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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