Should SEND output be reviewed by the GLP Quality Assurance Unit?

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SEND output should be subjected to similar QA and QC controls as those that have been applied to the production of individual data listings. On non-GLP studies the GLP Quality Assurance Unit does not generally audit the individual data listings and would consequently not audit the SEND dataset even if included in a regulatory submission; however, they do audit GLP studies. SEND datasets are a standardized format of the individual data listings (e.g. report appendix) included in a .pdf final study report submission. So, SEND datasets may in practice be used for study reviews, and therefore should generally be produced, reviewed, referenced, cited, and otherwise treated with similar controls as is applied to the individual listings.

Last revision by William.houser,09/21/2012

Questions and options when creating and exchanging data for SEND