Findings from CDISC Evaluation

Variable Navigator
    dm:  ds:  eg:   ie:  lb:    pe:    se:   sv:  ta:  te:  ti:  ta:


Findings from CDISC Evaluation
Data Table Name = dm Data Table Label=Demographics

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib dm.age Age in AGEU at RFSTDTC N 8 7 Variable name matches guidelines but not label which is: Age

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = ds Data Table Label=Disposition

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
3 datalib ds.epoch Trial Epoch C 9 7 Variable name matches guidelines but not label which is: Epoch

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = eg Data Table Label=ECG

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib eg ECG   . 10 Data name matches guidelines but not data label which is: ECG Test Results

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml




Findings from CDISC Evaluation
Data Table Name = ie Data Table Label=Inclusion/Exclusion Exceptions

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib ie Inclusion/Exclusion Exceptions   . 10 Data name matches guidelines but not data label which is: Inclusion/Exclusion Criterion Not Met
7 datalib ie.ietestcd Inclusion/Exclusion Criterion Short Name C 6 7 Variable name matches guidelines but not label which is: Incl/Excl Criterion Short Name

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = lb Data Table Label=Laboratory Tests

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib lb Laboratory Tests   . 10 Data name matches guidelines but not data label which is: Laboratory Test Results

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml



Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = pe Data Table Label=Physical Exam

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib pe Physical Exam   . 18 An expected variable PESTRESN is missing.
2 datalib pe Physical Exam   . 18 An expected variable PESTRESU is missing.

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml


Findings from CDISC Evaluation
Data Table Name = sv Data Table Label=Subject Visits

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib sv.svstdy Actual Study Day of Visit N 8 7 Variable name matches guidelines but not label which is: Study Day of Start of Visit

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = ta Data Table Label=Trial Arms

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib ta.epoch Trial Epoch C 30 7 Variable name matches guidelines but not label which is: Epoch

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = ti Data Table Label=Trial Inclusion

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib ti Trial Inclusion   . 10 Data name matches guidelines but not data label which is: Trial Inclusion/Exclusion Criteria
3 datalib ti.ietestcd Inclusion/Exclusion Criterion Short Name C 6 7 Variable name matches guidelines but not label which is: Incl/Excl Criterion Short Name

Generated on: 08/21/2009, 4:31:14 pm, Sy Truong
Located at: C:\apache\htdocs\cdisc\definexml