Module 12 2019

5 Most Common 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 dataset specifications • 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 • Mis-use 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

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