Tang 2009-04-13  4/21/2009 11:14 AM

Within this file, an evaluation was applied to metadata 2008-12-12.xls and the findings are listed as follows:

1. SE Variables - The SE Variables are not fully defined.  As highlighted below, the variable names appear to be labels and will be excluded from this evaluation.
   
   

   Domain	Variable	Label	Type
   SE	Study Identifier	Study Identifier	CHAR
   SE	DOMAIN	Domain Abbreviation	CHAR
   SE	Unique Subject Identifier	Unique Subject Identifier	CHAR
   SE	Sequence Number	Unique Subject Identifier	CHAR
   SE	Element Code	Element Code	CHAR
   SE	Description of Element	Description of Element	CHAR
   SE	Start Date/Time of Element	Start Date/Time of Element	CHAR
   SE	End Date/Time of Element	End Date/Time of Element	CHAR
   SE	Planned Order of Elements within Arm	Planned Order of Elements within Arm	NUM
   SE	Epoch	Epoch	CHAR
   SE	Description of Unplanned Element	Description of Unplanned Element	CHAR

   
    

2. Internal Attribute Consistency - An evaluation was applied to all the datasets from the set of metadata among themselves for consistency.  This is not yet compared with CDISC standards.  Some findings include:

   • Variable Label Inconsistencies 

     Data name	Variable	Type	Length	Label
     CO	idvar	C	100	Identifier Variable Name*
     SQ	idvar	C	100	Identifier Variable*

     

   SV	visit*	Visit Number
   VS	visitnum*	Visit Number

   • Variable Type Inconsistencies

     DA	visitnum	N*	8*	Visit Number*
     SV	visitnum	C*	100*	Visit Name*

    

3. Attribute Consistent with 3.1.1 - An evaluation was applied to compare against guidelines 3.1.1.  

   • Variable Label Inconsistencies

     Data Source	Domain	Variable	Type	Length	Label
     Metadata	CM	cmstdy	N	8	Study Day of Start of Event*
     CDISC 3.1.1	CM	cmstdy	N	8	Study Day of Start of Medication*

     
     

4. PROC CDISC - An example PROC CDISC was applied AE and MH as an example with findings:
    

   • AE
     [16] ERROR: Variable AEPRESP is not defined in this domain (AE) and must be dropped/deleted.
     [17] ERROR: SDTM-compliant datasets may contain only variables defined in the domain (AE).
      

   • MH
     [16] ERROR: Variable MHPRESP is not defined in this domain (MH) and must be dropped/deleted.
     [17] ERROR: SDTM-compliant datasets may contain only variables defined in the domain (MH).