The following documentation contains test scripts
and expected results for validating the CDISC Builder
Relrec 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
|
|
Related
Domain
|
Verify
list of domains matches list in documentation.
If
CDISC dataset is selected, related domain is
defaulted.
|
Instructions
3
|
|
Study
Identifier
|
Verify
name with special character such as comma and
quotes.
Verify
name that is long over 10 character.
|
Instructions 4
|
|
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 5
|
| Unique
Subject ID |
List
of variables match what is in the selected
dataset. Verify via PROC CONTENTS.
Default
to the first "Subject" variable it
finds.
|
Instructions 6 |
| Output |
The
[...] library manager returns the last libname
selected
Default
to RELREC for dataset name.
|
Instructions
7 |
| Base
Code |
Default
base program is the name of the selected dataset
with the extension of .sas.
Verify
the [...] button correctly assigns path.
|
Instructions
8 |
| OK/Cancel |
OK
button applies all selected parameters.
Memory
of all fields are retained.
Cancel
does not apply logic.
|
Instructions 9 |
| Save Code |
Program
is saved with proper comments
Generated
program is submitted and results verified
|
Instructions 10 |
| Find
Related |
Verify
case where no results are found, a dialog box is
displayed nothing findings.
Verify
report generated with proper footnote and headers.
|
Instructions 11 |
Instructions
1
Start the CDISC Builder application from the icon in
desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
Create
the following path if it does not already exist.
c:\temp\relrec\input
c:\temp\relrec\source
c:\temp\relrec\output
-
Submit
the following program:
libname testlib 'c:\temp\relrec\input';
libname outlib 'c:\temp\relrec\output';
data testlib.shoes;
set sashelp.shoes;
run;
data testlib.company;
set sashelp.company;
run;
data testlib.manage;
set sashelp.manage;
run;
-
In
RELREC screen, input an invalid path in the Source Data such as:
c:\invalidpath\invalidpath
-
Click on the "OK" button, the following
message appears:
Source data path entered does not exist.
-
Click on the OK button to close the
message.
-
Select a path without dataset in the
Source Data entry.
-
Click
"OK" button, verify a warning message appears:
The Data Sets list is empty.
-
Create
a temp directory named
very long name very long name very long name very long
name very long name very long name very long name very
long name very long name very long name very long name
very long name very long name very long name very long
name
-
Click
on [...] button to select that path that is longer than
200 characters.
-
Click
on the "OK" button.
-
There
is a message as follow:
WARNING: You cannot select a path longer than 200
characters using Select dialog. Please enter the path
directly to the Source Data field.
-
Input
that long path manually and click OK button again, verify
the warning message above no longer appears.
-
Click
[...] button next to Source Data field.
-
A
Select dialog box appears with OK and Cancel buttons.
-
Navigate
to a path that different from the old one and click
Cancel.
-
Nothing
happens.
-
Click
[...] button again and select this path 'c:\temp\cdisc\input'.
-
Click
OK button, verify the path in Source Data now is 'c:\temp\cdisc\input'.
Instructions
2
Start the CDISC Builder application from the icon in
desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, click [...] button next to Source Data field
to select this path 'c:\temp\relrec\input'
-
Verify
the Data Sets list lists all datasets in this location:
COMPANY
MANAGE
SHOES
-
From
the Data Sets list, select MANAGE dataset and click
Preview button. A report of MANAGE is created.
-
Select
more than one dataset such as COMPANY and MANAGE and
click Preview button. Verify the report now is
including Index of Datasets and Details of each
Dataset.
Instructions
3
Start the CDISC Builder application from the icon
in desktop.
-
Submit
the following program:
libname testlib 'c:\temp\relrec\input';
data testlib.ae(label = "Adverse Event");
set sashelp.shoes;
run;
data testlib.demog(label = "Demographics");
set sashelp.company;
run;
data testlib.co(label = "Comments");
set sashelp.manage;
run;
-
Select
RELREC icon from the CDISC Builder screen.
-
In RELREC
screen, verify all domains name in Related Domains list
match with ones in documentation as follow:
AE - Adverse Events
CM - Concomitant Meds
CO - Comments
DA - Drug Accountability DM - Demographics DS - Disposition DV - Protocol Deviations EG - ECG
Tests EX - Exposure IE - Inclusion / Exclusion
Exceptions LB - Laboratory Tests MB - Microbiology
Specimens MH - Medical History MS - Microbiology
Susceptibility PC - Phamacokinetics Concentrations PE - Physical Examinations PP -
Phamacokinetics Parameters QS - Questionnaires
RELREC - Relate Records SC - Subject Characteristics SE - Subject Elements SU
- Substance Use
SUPPQUAL - Supplemental Qualifiers SV - Subject Visits TA - Trial Arms TE - Trial Elements TI - Trial Inclusion/Exclusion Criteria
TS - Trial Summary TV - Trial Visits VS - Vital Signs
-
Select AE
dataset in Data Sets list, verify the related domain 'AE
- Adverse Events' is selected.
-
Select
DEMOG, the related domain now is 'DM - Demographics'.
-
Repeat
again with CO dataset, verify the related domain is
changed to 'CO - Comments'.
Instructions
4
Start the CDISC Builder application from the icon
in desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, click [...] button next to Source Data field
to select this path 'c:\temp\cdisc\input'.
-
Type a name
into Study Identifier textbox.
-
Verify that Study
Identifier could not input more than 10 characters.
Instructions
5
Start the CDISC Builder application from the icon
in desktop.
-
Submit
the following program:
data testlib.shoes;
attrib seqnum label = "Sequence Number" length=$20;
set sashelp.shoes; run;
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, click [...] button next to Source Data field
to select this path 'c:\temp\relrec\input'
-
In Data
Sets list, select COMPANY dataset, verify its variables
are displayed in Identification Variable.
-
Submit
the following program:
proc contents data=testlib.company;
run;
-
Verify the
variables in report similar to ones in Identification
Variable.
-
Click on
SHOES dataset, verify SEQNUM is selected as default
value of Identification Variable.
Instructions
6
Start the CDISC Builder application from the icon
in desktop.
-
Submit
the following program:
data testlib.shoes;
attrib subject label = "Subject" length=$20;
set sashelp.shoes; run;
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, click [...] button next to Source Data field
to select this path 'c:\temp\relrec\input'
-
In Data
Sets list, select COMPANY dataset, verify its variables
are displayed in Unique Subject ID Variable.
-
Submit
the following program:
proc contents data=testlib.company;
run;
-
Verify the
variables in report similar to ones in Unique Subject ID
Variable.
-
Click on
SHOES dataset, verify SUBJECT is selected as default
value of Unique Subject ID Variable.
Instructions
7
Start the CDISC Builder application from the icon in
desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
Click on the [...] button next to the Output list.
-
Type a Library Name "RELREC" with the output path such
as: C:\TEMP\RELREC\OUTPUT.
-
Click on the "Add" button then click on the "Back"
button.
-
In
RELREC screen, verify the default value of Output dataset
name is 'relrec'.
-
Click
Cancel to close RELREC screen.
-
From CDISC
Builder screen, click RELREC icon again.
-
Verify the
Output library in RELREC screen now is RELREC.
Instructions
8
Start the CDISC Builder application from the icon
in desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, remove value in Base Code field.
-
Select a
dataset in Data Sets list such as COMPANY.
-
Verify the
file name in Base Code field is the name of the selected
dataset with the extension of .sas and located at
current directory.
-
Click on
[...] button next to Base Code field and verify that the
Save As dialog box display all sas files and folders
located at current directory.
Instructions
9
Start the CDISC Builder application from the icon
in desktop.
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, input the following information:
Source Data: c:\temp\relrec\input
Data Sets: COMPANY
Related Domain: CO - Comments
Study Identifier: Protocol 1
Identification Variable: depthead
Unique Subject ID Variable: level5
Output: OUTLIB.RELREC
Base Code:
c:\temp\relrec\output\relrec_company.sas
-
Click OK
button, a report is
created for COMPANY dataset.
-
Close the report, click on the Cancel button and go back RELREC screen again from CDISC Builder.
-
Verify
that Source Data brings information of last time.
Instructions
10
Start the CDISC Builder application from the icon
in desktop.
-
Select RELREC icon from the CDISC Builder
screen.
-
In RELREC screen, input the following
information:
Source Data: c:\temp\relrec\input
Data Sets: COMPANY
Related Domain: CO - Comments
Study Identifier: Protocol 1
Identification Variable: depthead
Unique Subject ID Variable: level5
Output: OUTLIB.RELREC
-
Click Save Code button, the Save Code
screen is displayed with default values of Path is
current directory and File name is 'relrec'.
-
Click OK button, View Code screen shows
the code of relrec macro call.
-
Copy that code and submit it. Verify it created a
report of COMPANY dataset.
Instructions
11
Start the CDISC Builder application from the icon
in desktop.
-
Submit the
following program:
data testlib.dm(label="Demographics");
attrib relate label="Relation";
set sashelp.manage;
relate="abc";
run;
-
Select
RELREC icon from the CDISC Builder screen.
-
In
RELREC screen, input the following information.
Source Data:
C:\temp\relrec\input
Data Sets: DM
-
Click on
Find Related button.
-
It generates a report that Find Related Domain for: DM.
-
Verify
that your current windows account name, the current date
and time, and the current "saspgm" path are displayed
at the bottom of the html file.
For more information, please contact MXI
.
|