The following documentation contains test scripts
and expected results for validating the CDISC Builder
Suppqual tool. Do the following to verify proper
installation:
- Start CDISC Builder application by double
clicking on the desktop icon.
-
Perform each test by performing the steps specified
by the instructions.
- Evaluate the results of each step by comparing
them with results described in the Documentation
column.
| Script
|
Description
|
Documentation
|
| Source
Data |
Type
invalid path
Navigate
to location with no SAS datasets
Path
name that is longer than 200 characters
Use
[...] path navigation
|
Instructions
1
|
| Data
Sets |
List
of datasets match what is in the selected path
Verify
preview button with a separate PROC PRINT |
Instructions
2
|
| Variable
Names |
List
of names are from the selected datasets. This
is confirmed through PROC CONTENTS
Verify
Select all button toggle. |
Instructions
3
|
|
Variable
Origin
|
List
the source type including CRF, ASSIGNED, or DERIVED.
The
[...] button allows assignment.
Default
source type to be CRF.
Select
All button in Variable Origin toggles.
|
Instructions 4
|
|
Related
Domain
|
Verify
list of domains matches list in documentation.
If
CDISC dataset is selected, related domain is
defaulted.
Verify
the assignment of related domain as shown in the
assigned related domain.
|
Instructions 5
|
|
Study
Identifier
|
Verify
name that is long over 200 characters. |
Instructions 6 |
|
Identification
Variable |
List
of variables match what is in the selected
dataset. Verify via PROC CONTENTS.
Default
to the first "SEQ" variable it
finds.
|
Instructions
7 |
|
Unique
Subject ID Variable |
List
of variables match what is in the selected
dataset. Verify via PROC CONTENTS.
Default
to the first "Subject" variable it
finds.
|
Instructions 8
|
| Output |
The
[...] library manager returns the last libname
selected |
Instructions 9
|
| Merge
into SUPPQUAL |
Verify
with and without selection when the OK button is
clicked. |
Instructions 10 |
| Base
Code |
Default
base program is the name of the selected dataset
with the extension of .sas.
Verify
the [...] button correctly assigns path.
|
Instructions 11 |
| OK/Cancel |
OK
button applies all selected parameters.
Memory
of all fields is retained.
Cancel
does not apply logic.
|
Instructions 12 |
| Save
Code |
Program
is saved with proper comments
Generated
program is submitted and results verified |
Instructions 13 |
Instructions
1
Start the CDISC Builder application from the icon in
desktop.
-
Create the
following path if it does not already exist.
c:\temp\cdiscbuilder\input
c:\temp\cdiscbuilder\source
c:\temp\cdiscbuilder\output
-
Submit
the following program:
libname
input 'C:\temp\cdiscbuilder\input';
libname
source 'C:\temp\cdiscbuilder\source'; libname
output 'C:\temp\cdiscbuilder\output';
data
input.shoes;
set sashelp.shoes; run; data
input.company;
set sashelp.company; run; data
input.manage;
set sashelp.manage; run; data
input.ae (label="Adverse
Events");
set sashelp.shoes; run;
-
On the Main screen, select Source Data as
'C:\temp\cdiscbuilder\input' and Data Sets as AE.
-
Click on
Suppqual icon to open Suppqual screen.
-
Verify that Source Data is
'C:\temp\cdiscbuilder\input' and Data Sets as AE.
-
Type an invalid path such as 'C:\invalid'
in Source Data textbox and click on the Enter button.
-
Verify that the warning message is
displayed:
Source Data path does not exist.
-
Click OK to close the message box. Verify
that Datasets list box is empty.
-
Type
'C:\temp\cdiscbuilder\input' in
Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Type an empty directory such as
'C:\temp\empty' in Source Data textbox and click on the
Enter button.
-
Verify that Datasets
list box is empty.
-
Create a directory that is longer than 200
characters such as:
C:\temp\This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long
path.
-
Type this path in Source Data textbox and
click on the Enter button.
-
Verify that the Warning message is
displayed:
You cannot select a path longer than 200 characters
using Select dialog. Please enter the path directly to
the Source Data field.
-
Click on the OK button.
-
Click on [...] button next to Source Data
textbox.
-
Select
'C:\temp\cdiscbuilder\input' path
and then click OK.
-
Verify that Datasets
list box is filled
with all datasets in 'C:\temp\cdiscbuilder\input'.
-
Click on [...] button next to Source Data
textbox.
-
Select the path 'C:\temp\This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path. This is a test of long path.'.
-
Click OK button. Verify that there is a
warning message as the following:
Instructions
2
Start the CDISC Builder application from the icon in
desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box and dataset AE is
selected.
-
Click on Preview button. Verify that the
first 100 observations of dataset AE are displayed.
-
Open SAS program and submit the following
code:
libname
input 'C:\temp\cdiscbuilder\input';
proc
print
data=input.ae;
run;
-
Verify that the result of the above code
is the same with the result of the Preview button.
Instructions
3
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select COMPANY from the Datasets
list box.
Verify that Variable Names list box is filled with the
variables in dataset COMPANY.
-
Open SAS program and submit the following
code:
libname
input 'C:\temp\cdiscbuilder\input';
proc
contents
data=input.company;
run;
-
Verify that the variables in the result
are the same with variables in variables in the Variable
Names list box.
-
Click on Select All button. Verify that
all variables in Variable Names list box are selected.
-
Click on Select All button again. Verify
that no dataset in Variable Names list box is selected.
Instructions
4
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual
screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select COMPANY from the Datasets
list box.
Verify that Variable Names list box is filled with the
variables in dataset COMPANY.
-
Select
'level1, level2, level5' in the Variable Names list box.
Verify that there is 3 CRF value in Origin Type.
-
Click [...]
button next to Origin Type list box. Verify that Origin
Data Type screen is displayed.
-
Select
'level2' in Variables list box. Select Source Type is
'ASSIGNED' and click on [<<] button.
-
Verify that
Original Source of variable 'level2' is 'ASSIGNED'.
-
Select
'level1' in Variables list box. Select Source Type is
'DERIVED' and click on [<<] button.
-
Verify that
Original Source of variable 'level1' is 'DERIVED'.
-
Click on OK
button to return to Suppqual screen. Verify that Origin
Type of variable 'level2' is 'ASSIGNED' and variabled
'level1' is 'DERIVED'.
-
Click [...]
button next to Origin Type list box. Verify that Origin
Data Type screen is displayed.
-
Click on
Select All button. Verify that all variables are selected.
-
Select 'CRF'
in Source Type and click on [<<] button.
-
Verify that
Original Source of all variables are 'CRF'.
-
Click Cancel
button.
-
Verify that
Origin Type of variable 'level2' is 'ASSIGNED' and
variabled 'level1' is 'DERIVED'.
Instructions
5
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box and dataset AE is
selected.
-
Click on Related Domain
combo box. Verify
that all CDISC datasets are display.
-
Select dataset COMPANY in Datasets
list box.
Verify that no domain in Related Domain is selected.
-
Select dataset AE in Datasets
list box.
Verify that domain AE in Related Domain is selected.
Instructions
6
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual
screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box and dataset AE is
selected.
-
Type a name
into Study Identifier textbox. Verify that Study
Identifier could not input more than 10 characters.
Instructions
7
Start the CDISC Builder application from the icon in
desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select
COMPANY from the Datasets list box.
Verify that Identification Variable combo box is
filled with the variables in dataset COMPANY.
-
Open SAS program and submit the following
code:
libname
input 'C:\temp\cdiscbuilder\input';
proc
contents
data=input.company;
run;
-
Verify that the variables in the result
are the same with variables in variables in the
Identification Variable combo box.
Instructions
8
Start the CDISC Builder application from the icon in
desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in 'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select
COMPANY from the Datasets list box.
Verify that Unique Subject ID combo box is filled
with the variables in dataset COMPANY.
-
Open SAS program and submit the following
code:
libname
input 'C:\temp\cdiscbuilder\input';
proc
contents
data=input.company;
run;
-
Verify that the variables in the result
are the same with variables in variables in the Unique
Subject ID combo box.
Instructions
9
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select AE from the Datasets
list box.
-
Click on [...]
button next to Output. Verify that Libname
Management is displayed.
-
Select library OUTPUT and then click Back
button.
-
Verify that the libname OUTPUT is
selected in the Output combo box.
-
Select
"AE - Adverse Events" in Related Domain combo box.
-
Verify that
output dataset is 'SUPPQUAL_AE'.
Instructions
10
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select
COMPANY from the Datasets list box.
-
Verify that
Base Code textbox has value 'suppqual_company_.sas'.
-
Select AE from the Datasets
list box.
-
Select
"CO - Comments" in Related Domain combo box.
-
Verify that
Base Code textbox has value 'suppqual_ae_co.sas'.
-
Click on the
[...] button next to the Base Code textbox.
-
Select
'C:\temp\cdiscbuilder\output\suppqual_ae.sas' in Save As
dialog box and click OK button.
-
Verify that
Base Code textbox has value 'C:\temp\cdiscbuilder\output\suppqual_ae.sas'.
Instructions
11
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select AE from the Datasets
list box.
-
Select
'Product' in Variable Names list box.
-
Select 'AE - Adverse Events' in the
Related Domain.
-
Type '12345' in Study Identifier textbox.
-
Select
'Region' in Identification Variable combo box.
-
Select 'Region' in Unique Subject ID
Variable combo box.
-
Select Output with libname 'OUTPUT' and
dataset 'SUPPQUAL_AE'.
-
Uncheck
'Merge into one SUPPQUAL dataset'.
-
Type 'c:\temp\cdiscbuilder\output\suppqual_ae_ae.sas'
-
Click OK button. Verify that there is a
message box as the following:
-
Click OK button.
Verify that View Code button is displayed. Click Back
button.
-
Navigate to
the Output directory, verify that dataset suppqual_ae and
dataset suppqual_ae_index have been created.
-
Click Cancel button to return to the Main
screen.
-
Click on
Suppqual icon. Verify that Suppqual screen is displayed.
-
Verify that all parameters are selected as
the previous session.
Instructions
12
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual
screen.
-
On the Suppqual screen, type 'C:\temp\cdiscbuilder\input'
in Source Data textbox and click on the Enter button.
-
Verify that all datasets in
'C:\temp\cdiscbuilder\input'
are inserted in Datasets list box.
-
Select AE from the Datasets
list box.
-
Select
'Product' in Variable Names list box.
-
Select 'AE - Adverse Events' in the
Related Domain.
-
Type '12345' in Study Identifier textbox.
-
Select
'Region' in Identification Variable combo box.
-
Select 'Region' in Unique Subject ID
Variable combo box.
-
Select Output with libname 'OUTPUT' and
dataset 'SUPPQUAL_AE'.
-
Check 'Merge
into one SUPPQUAL dataset'.
-
Type 'c:\temp\cdiscbuilder\output\suppqual_ae_ae.sas'
-
Click OK button. Verify that there is a
message box as the following:
-
Click OK button.
Verify that View Code button is displayed. Click Back
button.
-
Navigate to
the Output directory, verify that dataset suppqual_ae,
suppqual_ae_index and suppqual have been created.
-
Select 'AU -
Autopsy' in the Related Domain.
-
Click OK button. Verify that there is a
message box as the following:
-
Navigate to
the Output directory, verify that dataset suppqual_au and
suppqual_au_index have been created.
-
verify that
dataset suppqual have the content of both dataset
suppqual_ae and dataset suppqual_ae.
Instructions
13
Start the CDISC Builder application from the icon
in desktop.
-
Click on
Suppqual icon to open Suppqual screen.
-
On the Suppqual screen, click Save Code
button. Verify that Save Code dialog is displayed.
-
Input the path as
'C:\temp\cdiscbuilder'
and the file name as 'suppqual_ae_ae'.
-
Click OK button. Verify that View Code
screen is displayed.
-
Review the code and verify that all the
parameters are inserted in the right order of the macro.
-
Click Back button to return to the
Suppqual screen.
-
Navigate to the
'C:\temp\cdiscbuilder'
directory.
-
Submit the 'suppqual_ae_ae.sas' program and
verify that the result is the same with the result of the
Instruction 12
For more information, please contact MXI
.
|