Module 12 Presentations

26/01/2024

Module 4 and 5 Study Data Specifications

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The Organisation for Professionals in Regulatory Affairs

45

5 Most Common Data Challenges • Inconsistencies between the SAS Datasets and the Dataset specifications • The number/names of variables in the dataset do not match those listed in the datasetspecifications • Incomplete variable specifications • Incorrect variables listed in derivations and incorrect naming convention used • Dataset Specifications not created with eSubmission in mind for our tools • Not able to create define file for submission without reformatting • Misuse of the word CDISC and it’s implication on submission requirements

• eSubmissions not considered early enough and insufficient time allowed

The Organisation for Professionals in Regulatory Affairs

10

46

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