Sample submission 2009-06-10

Within this file, an evaluation was applied to the datasets  and the findings are listed as follows:

1. Leading Space Label - Most if not all the SAS label defined for the dataset has a leading blank space.  For example: AE dataset with variable STUDYID has label as shown below where the leading space is highlighted.
   
      Study Identifier
   
   A complete list of labels with leading space are found at: Difference Test 1.
   
2. Missing Label - The datasets were missing dataset level label for each domain.  For example, AE domain would need the label "Adverse Events".  A complete list of missing labels are found at: Difference Test 5.
    
3. Subject vs. Patient - We tend to use "Subject" as a standard rather than refer to "Patient".  Only a suggestion but we can consider updating CO domain with the comment in value of COVAL.
   
   from:
   PATIENT DID NOT TAKE DOSE
   
   to:
   SUBJECT DID NOT TAKE DOSE
   
4. Expected Variables - In the PE domain, there were two variables that was expected but are missing from the dataset:
   

   Obs	Library Name	Dataset and Variable	Case Number	Comments
   2	datalib	pe	18	An expected variable PESTRESN is missing.
   3	datalib	pe	18	An expected variable PESTRESU is missing.