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 Demographics   . 74 The DM domain contains a variable ARMCD 'SCRNFAIL' which is not found in the TA domain.
2 datalib dm Demographics   . 79 In observation 5, the value for variables: ARMCD and ARM are not found in the TA domain.

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml

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

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib eg ECG Test Results   . 40 In observation 12, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
2 datalib eg ECG Test Results   . 40 In observation 13, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
3 datalib eg ECG Test Results   . 40 In observation 19, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
4 datalib eg ECG Test Results   . 40 In observation 20, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
5 datalib eg ECG Test Results   . 40 In observation 26, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
6 datalib eg ECG Test Results   . 40 In observation 27, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
7 datalib eg ECG Test Results   . 40 In observation 33, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
8 datalib eg ECG Test Results   . 40 In observation 34, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
9 datalib eg ECG Test Results   . 40 In observation 40, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
10 datalib eg ECG Test Results   . 40 In observation 41, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
11 datalib eg ECG Test Results   . 40 In observation 47, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
12 datalib eg ECG Test Results   . 40 In observation 48, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
13 datalib eg ECG Test Results   . 40 In observation 5, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
14 datalib eg ECG Test Results   . 40 In observation 54, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
15 datalib eg ECG Test Results   . 40 In observation 55, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.
16 datalib eg ECG Test Results   . 40 In observation 6, the value for variable EGDRVFL equals 'Y' but the value for variable EGORRES is null.

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml

Findings from CDISC Evaluation
Data Table Name = ie Data Table Label=Inclusion/Exclusion Criteria Not Met

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib ie Inclusion/Exclusion Criteria Not Met   . 10 Data name matches guidelines but not data label which is: Inclusion/Exclusion Criterion Not Met
2 datalib ie Inclusion/Exclusion Criteria Not Met   . 42 In observation 1, the value for variable IETEST is greater than 40 characters.

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml

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

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib lb.lbstresu Standard Units C 7 57 In observation 17, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
2 datalib lb.lbstresu Standard Units C 7 57 In observation 18, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
3 datalib lb.lbstresu Standard Units C 7 57 In observation 37, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
4 datalib lb.lbstresu Standard Units C 7 57 In observation 56, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
5 datalib lb.lbstresu Standard Units C 7 57 In observation 57, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
6 datalib lb.lbstresu Standard Units C 7 57 In observation 78, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
7 datalib lb.lbstresu Standard Units C 7 57 In observation 79, the value for variable LBSTRESU has a missing value while the variable LBSTRESN has a non missing values.
8 datalib lb.lbtestcd Lab Test or Examination Short Name C 7 22 The LBTESTCD which is named "GLUC" has corresponding LBSTRESU which is not consistent across all records.

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml
 
Findings from CDISC Evaluation
Data Table Name = qs Data Table Label=Questionnaire

Obs Library Name Dataset and Variable Variable Label Variable Type Variable Length Case Number Comments
1 datalib qs Questionnaire   . 10 Data name matches guidelines but not data label which is: Questionnaires

Generated on: 10/16/2009, 3:23:54 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.taetord Order of Element within Arm N 8 7 Variable name matches guidelines but not label which is: Planned Order of Elements within Arm

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml

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

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

Generated on: 10/16/2009, 3:23:54 pm, Sy Truong
Located at: c:\apache\htdocs\cdisc\definexml