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When traceability is successfully implemented, reviewers are able to identify

 
 
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When traceability is successfully implemented, reviewers are able to identify
by John Zhang - Monday, 9 November 2015, 8:22 PM
 

a. information that exists in the submitted SDTM study tabulation data

b. information that is derived or imputed with the ADaM analysis dataset

c. the method used to create derived or imputed data

d. information used for analyses, in contrast to information that is not used for analyses yet is included to support traceability or future analysis


 
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two levels of tracebility
by John Zhang - Monday, 9 November 2015, 8:24 PM
 

a. Metadata traceability enables the user to understand the relationship of the analysis variable to its source dataset(s) and variable(s) and is required for ADaM compliance.

b. Data point traceability enables the user to go directly to the specific predecessor record(s).