Clinical Data Acceptance Testing Procedure
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[edit] Title
Clinical Data Acceptance Testing Procedure
[edit] Author
Sunil Gupta, Sunil.Gupta@Quintiles.com
- CDISC for Medical Device Team (Industry Expert)
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New Webinar: Effective Clinical Data Acceptance Testing
February 19, 2009 at 11:00 a.m. - 12:30 p.m. (EST), Register Now - [1]
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[edit] 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 U.S. 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.
This paper will review an effective method to implement a clinical data acceptance testing procedure using edit check macros for creating an RTF file with minimum SAS® expertise and maintenance. In addition, because all clinical studies have common issues, the edit check macros developed could easily be used to check similar data issues across other clinical studies.
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More information on popular SAS clinical class: Best Practices in SAS Statistical Programming for Regulatory Submission [2].
