As-ERAS-OPQ01-Case Processing and Workflow

Case Processing and
Operational/Performance Qualification
Workflow
Case Processing and Workflow
DOC ID: Page 1 of 47

PROPRIETARY & CONFIDENTIAL
Case Processing and
Workflow
Table of Contents
1. REVISION LOG............................................................................................................................ 2
2. PRE-EXECUTION APPROVALS..................................................................................................2
3. TEST OVERVIEW........................................................................................................................ 3
4. TEST PROCEDURE.....................................................................................................................5
5. EXECUTION SUMMARY............................................................................................................ 29
1. REVISION LOG
Revision Revision Notes Revised By Date
0 Initial version Nisha Verma 22 Mar 2022
2. PRE-EXECUTION APPROVALS
PRE-EXCECUTION APPROVAL
By affixing their signatures, the individuals below acknowledge that they have reviewed and approved (prior
to execution) the contents of this document.
Role Signature
Approval
(Quality)

Case Processing and
Workflow
3. TEST OVERVIEW
Test Number OPQ

Case Processing and Workflow
Test Name
1.14.1 5.2.1 5.3.1 5.4.1 5.5.1 5.6.1

5.7.1 5.8.1 5.8.2 5.11.1 5.12.1 5.17.1
Requirement(s) 5.18.1 5.19.1 5.22.1 5.24.1 5.38.1 5.39.1
being tested (FRS) 5.40.1 5.46.1 6.1.1 6.3.1 6.4.1 6.5.1
6.11.1 6.13.1 6.14.1 6.16.1 6.21.1 6.23.1
6.24.1 6.27.1 X X X X
Test Objective Verify all the requirement listed in above section.

Case Processing and
Workflow
1. Following user account should be available to the tester:

 Triage User
 Data Entry User
 Quality Review User
 Medical Review User
 Finalization User
Test Assumptions &  Distribution User
Requirements
2. One sample PDF should be available to the tester for attaching into the
case.
3. One user defined text field in General Information section should be enabled
with name 'ERASCA UDF' in Argus Console>System Configuration >Field
properties
Test Inputs N/A
Test Outputs Screenshots
Run #
Test data Refer Datasheet:

Case Processing and
Workflow
4. TEST PROCEDURE
Step Instruction Expected Results Actual Pass/ Initials/Date

1. Launch Argus Safety Application Argus Safety login page See associated Test Script Execution Form.
using <Argus URL> is displayed
Username and
Login to Argus Safety Application password are entered
by entering following details: successfully.
Username: <Triage User> <Triage User> is able

Password: Enter Password to login successfully.
User Id is recorded.
(Take a screen shot)
Click on Login button
Record the User ID in the Actual

Result column.
2. Initial Case Entry screen See associated Test Script Execution Form.
Go to Case Actions  New is displayed.

Case Processing and
Workflow

3. The specified data is See associated Test Script Execution Form.
Enter the data as per Datasheet > entered successfully as
BookIn tab for the following fields: per Datasheet > BookIn
tab > General Section.
General section:
• Initial Receipt Date
• Central Receipt Date
• Country
• Report Type
• Description as Reported
• Onset Date/Time
Click on Select button besides

Clinical Trial Selection
Project ID
Webpage dialog box
Select or enter Data for the following appears.
fields as per Datasheet > BookIn
tab:
Study is selected
• Project ID successfully.
• Study ID
• Center ID (populated once study ID
is selected)
Click on Select in Clinical Trial

Selection Webpage dialog box.
BookIn Section is
Click [Continue] button displayed.

Case Processing and
Workflow

4. See associated Test Script Execution Form.
Enter the data as per Datasheet > The specified data is
BookIn tab for the following fields: entered successfully as
per Datasheet > BookIn
tab
Reporter section
• Sal.
• First Name
• Middle Name
• Last Name
• Institution
• Institution ID
• Department
• Country
• State
• Postal Code
• Intermediary
Patient section
• First Name
• Last Name
• Initials
• Date of Birth
• Age
• Units
• Gender

Case Processing and
Workflow

Click the Book-In button. The case is booked and
opened successfully and
Ignore any warnings and click on by default General
Yes when asked to open the case Screen is displayed.
form.
Case Number is
Record the Case Number as {Test recorded.
Case 01} .
Verify Case Number is displayed in Case Number is

following numbering format: displayed in [YYYY]
[#####] numbering
[YYYY][#####] format.
Click and try to edit Case Number.
Verify User is not able to modify case User is not able to

number assigned by system. modify case number
assigned by system.

Navigate to Events > Event Data is entered
Information section. successfully.
Verify that Outcome of Event is
“Fatal”

Case Processing and
Workflow

Navigate to Events > Event The specified data is
Assessment section. entered successfully as
per Datasheet > Event
Assessment-Bookin
Enter the data as per Datasheet > tab.
Event Assessment-Bookin tab
Save the case Case save webpage

dialog box appears
stating “Study is not
blinded and study drug
has not been selected.
Do you wish to select the
study drug before saving
the case?”
Select ‘Yes’
User is automatically
navigated to Products
Select Study Drug as “ERAS-601, tab
Capsule’ from drop down
Case is saved
(Take a screen shot) successfully.

Click on the Forward Case icon Case is routed to next
on the top right screen workflow state.
On the Case Routing dialog,

Populate with the following values: Case is closed
successfully.
“Route to Next State” as ‘Data Entry’
Enter Comment as “Testing”
Click on OK in the Case Routing
dialog.
Notes: Click on OK if the Case save

dialog appears.

Go to Case Actions  New Initial Case Entry screen
is displayed.

Case Processing and
Workflow

10. The specified data is See associated Test Script Execution Form.
Enter the data as per Datasheet > entered successfully as
BookIn tab for the following fields: per Datasheet > BookIn
tab > General Section.
General section: Clinical Trial Selection

• Country Webpage dialog box
appears.
• Report Type
• Description as Reported
• Onset Date/Time
Click on Select button besides

Project ID
Select or enter Data for the following Study is selected
fields as per Datasheet > BookIn successfully.
tab:
• Project ID
• Study ID
• Center ID (populated once study ID
is selected)
Click on Select in Clinical Trial

Selection Webpage dialog box
Replace Product Name with ‘ERAS-

601’
Reporter section
• Institution ID
Patient section
• Pat. ID
• Date of Birth
Click On [Search] button
{Test Case 01} is

Verify {Test Case 01} is displayed displayed under Total
under Total Number of rows section. Number of rows section.

Case Processing and
Workflow

11. Case Summary See associated Test Script Execution Form.
Right Click on {Test Case 01} Webpage dialog box
displayed under Total Number of appears.
rows section
Select Case Summary Option
Case Summary
Click on Close Webpage dialog box is
closed successfully.
12. Log out of Argus Safety <Triage User> is See associated Test Script Execution Form.
Application as <Triage User> successfully logged out
from Argus Safety
Application.
13. Login to Argus Safety Application <Data Entry User> is See associated Test Script Execution Form.
as a <Data Entry User> able to login
successfully.
Record the User ID in the Actual User ID is recorded.
Result column.

Case Processing and
Workflow

14. Navigate to Worklist > New See associated Test Script Execution Form
{Test Case 01} is
displayed in search
In Search Case filter criteria enter results.
following details:
Filter: Case Number Case is accepted

Value: <{Test Case 01} > successfully.
Click on Search
Right click on Search Result and

select Accept Case
Verify Case Assigned To and

Owner is displayed as <Data Entry
User>
15. Navigate to Worklist > Open See associated Test Script Execution Form.
{Test Case 01} is
displayed in search
following details:
Filter: Case Number

Value: <{Test Case 01}>
Click on Search
Verify {Test Case 01} is displayed

in search results.

Case Processing and
Workflow

16. {Test Case 01} opens See associated Test Script Execution Form.
Click on {Test Case 01} hyperlink successfully.
and open it.
Case Status is displayed

Verify that the case is in the ‘Data as ‘Data Entry’.
Entry’ state
Verify Case Priority is displayed as 1 Case priority is displayed

as 1
17. Classification section See associated Test Script Execution Form

In General Information section is displayed.
Classification is entered
Go to Classification section successfully.
Enter Classification as ‘Clinical

Trial’
18. Data is successfully See associated Test Script Execution Form

In General Information section
entered in the ERASCA
Enter ERASCA UDF as ‘Testing’ UDF field
19. Data is entered See associated Test Script Execution Form.

In the General tab > Reporter successfully in Reporter
Information section Information section as
per Datasheet >
General > Reporter
Enter the data as per Datasheet > Information > SN 1
General > Reporter Information >
SN 1

Case Processing and
Workflow

20. Data is entered See associated Test Script Execution Form
Click on (New) in Reporter successfully in Reporter
Information section Information section as
Enter the data as per Datasheet > per Datasheet >
General > Reporter Information > General> Reporter
SN 2 Information > SN 2
21. Patient tab is displayed. See associated Test Script Execution Form.
Navigate to Case FormPatient
tab Data is entered
In Patient Information section successfully in patient
information section.
Enter the data as per Datasheet >

Patient > Patient Information
section

22. Data is entered See associated Test Script Execution Form
Go to Patient details section successfully in Patient
Details section.

Patient > Patient Details section
23. See associated Test Script Execution Form

Go to Pregnancy Information Data is entered
section successfully in
Pregnancy Information
section
Patient > Pregnancy Information
section

Case Processing and
Workflow

24. Go to Other Relevant Data is entered See associated Test Script Execution Form.
History section successfully in Other
Relevant
History section.
Patient > Other Relevant
History section
25. Go to Lab Data section Data is entered See associated Test Script Execution Form.
successfully in Lab
Data section
Patient > Lab Data section
Save the case Case is saved

(Take a screen shot) successfully.
26. Lab Test Data See associated Test Script Execution Form.
Navigate to Lab Data section: Information is added to
Click on Add Test the case.
Enter Lab Data as reported: Blood Case is saved

Pressure successfully.
Unit: millimeter of mercury
Normal Low: 90
Normal High: 140
Click on Add Date

Enter Date as ’17-Jul-2019’
Results:90-140
Assessment: Normal
Notes: Lab Test Results are normal.
Save the case

27. Lab Test Result is See associated Test Script Execution Form.
Right Click on Newly added Lab Test deleted successfully.
Results
Select Delete Option

Case Processing and
Workflow

28. Navigate to Products tab Products tab is See associated Test Script Execution Form.
displayed.
In Product Information section
Data is entered
successfully per
Enter the data as per Datasheet > Datasheet > Patient >
Patient > Product Product
Information section Information section

29. In Dosage Regimens section Data is entered See associated Test Script Execution Form.
successfully as per
Datasheet > Patient >
Enter the data as per Datasheet > Dosage
Patient > Dosage Regimens section
Regimens section

Click on New button to add new Product Browser opens.
product
New Product is added
Click on Select button successfully from
Company Product
Enter Trade name as ‘Palbociclib’ dictionary.
Click on Select
Save the case. Case is saved
. successfully.

Case Processing and
Workflow

Click on New button to add new New Product is added
product successfully from WHO
DRUG dictionary.
Enter Product name as
‘Omeprazole’
Click on encode
Click on select button from WHO Case is saved
DRUG dictionary. successfully.
Save the case.
Concomitant product is
added.
Select Concomitant radio button.

Click on New button to add new New Product is added
product successfully from WHO
C DRUG dictionary.
Enter Product name as
’Paracetamol’
Click on encode Case is saved
successfully.
Click on select button from WHO
DRUG dictionary.
Save the case. Treatment/Other radio
button is checked.
Select Treatment/Other radio button.
33. Navigate to Events tab Events tab is displayed. See associated Test Script Execution Form.
In Event Information section

Data is entered
successfully as per
Datasheet > Events >
Enter the data as per Datasheet > Event
Events > Event Information section
Information section

Case Processing and
Workflow

34. Navigate to Events tab Events tab is displayed. See associated Test Script Execution Form.
In Event Death Details Section Data is entered

successfully as per
Enter the data as per Datasheet > Event Death Details
Events > Event Death Details section
section
Data is entered
successfully as per
Enter the data as per Datasheet > Datasheet > Events >
Events > Cause of Death and Cause of Death and
Autopsy Results Autopsy Results

Navigate to Event Assessment Data is entered
Section successfully as per
Enter the data as per Datasheet > Event
Events > Event Assessment section
Assessment section

Case Processing and
Workflow

Navigate to Analysis tab Analysis tab is
displayed
In Narrative section
Click on [Generate] button

Narrative Template -
Webpage dialog box
Select “Clinical Trial case Narrative appears
Template” and click on Append.
Verify Narrative section is auto- Narrative section is auto-

populated correctly as per Auto populated correctly as
Narrative template “Clinical Trial case per Auto Narrative
Narrative Template”. template “Clinical Trial
case Narrative
Template”.
Append following Data in
Autogenerated narrative:
‘Test Narrative’ Free Text data is
appended in Narrative
(Take a screen shot) section
Notes: Execute this step only if the

Auto-narrative template has been
approved. In case this step has not
been executed populate N/A in
Actual 'Result ' section as well as
'Supporting evidence/screen shots'
section

Case Processing and
Workflow

Narrative webpage
dialog box appears
Click on icon in Narrative
section
German Language is
From Language drop down select
selected successfully.
Language as ‘German’
German Language
Enter following Data in German
Narrative is entered
section:
successfully.
"Test Deutsch Erzählung Eintrag im
Fall: Keine zusätzliche Anamnese
wurde vom Prüfarzt berichtet Keine
relevanten Begleitmedikationen
wurden berichtet Die folgenden
Medikamente wurden berichtet"
Click on OK
Save the case. Case is saved

successfully.

Go to Case Analysis > Case Narrative Template -
Comment section Webpage dialog box
appears
Click on [Generate] button
Select “Clinical Trial case Narrative

Template” and click on Append.
Verify Narrative section is auto- Narrative section is auto-

populated correctly as per Auto populated correctly as
Narrative template “Clinical Trial case per Auto Narrative
Narrative Template”. template “Clinical Trial
case Narrative
Template”.

Case Processing and
Workflow

Navigate to Additional Additional Information
Information tab tab is displayed
Click on [Attach File]
Attachment Webpage
dialog box appears
File is attached
In Attachment Webpage dialog box successfully.
Click on [Browse] button and
attach any PDF file.
Click Ok
Data is entered
Enter Data as follows: successfully.
Classification: Source Document
Date: <Today’s date>


successfully.
“Route to Next State” as ‘Quality
Review’
dialog.

dialog appears.
41. Log out of Argus Safety Application See associated Test Script Execution Form.
as <Data Entry User> is
successfully logged out
<Data Entry User> from Argus Safety
Application.

Case Processing and
Workflow

42. Login to Argus Safety Application <Quality Review User> See associated Test Script Execution Form.
as a <Quality Review User> is able to login
successfully.
Result column. User Id is recorded.
{Test Case 01} is
displayed in search
following details:

Value: <{Test Case 01}> successfully.
Click on Search

select Accept Case
Verify Case Assigned To is

displayed as <Quality Review
User>

Case Processing and
Workflow

{Test Case 01} is
displayed in search
following details:
Filter: Case Number


in search results.
Go to Case Actions Open successfully.
Search for {Test Case 01} and open
it.
Case is in the ‘Quality
Review’ state.
Verify that the case is in the ‘Quality
Review’ state
Verify Case Priority is displayed as 1. Case Priority is displayed

as 1.

Case Processing and
Workflow

46.
Navigate to Activities tab Action item is
successfully added to the
In Action Items section update case.
following details:
Date Open: <Today’s date> Case is saved

Code: CCORR successfully.
Date Completed: <blank>

Group: Data Entry
Save the case
47. Case is routed to next See associated Test Script Execution Form.
Click on the Forward Case icon workflow state.
on the top right screen
Populate with the following values:
Click on OK in the Case Routing Case is closed
dialog. successfully.
Note: Click on OK if the Case save

dialog appears.
48. Log out of Argus Safety Application <Quality Review User> See associated Test Script Execution Form.
as is successfully logged
out from Argus Safety
<Quality Review User> Application.

Case Processing and
Workflow

Record the User ID in the Actual successfully.
Result column.
User Id is recorded.
it.
Case is in the ‘Data
Entry’ state.
Verify that the case is in the ‘Data
Entry’ state

successfully updated.
In Action Items section update
following details:
Date Open: <Today’s date>

Code: CCORR
Date Completed: <Today’s date>
Group: Data Entry

Case is saved
successfully.
Save the case

Case Processing and
Workflow


successfully.
Review’
dialog.

dialog appears.
53. Log out of Argus Safety Application <Data Entry User> is See associated Test Script Execution Form.
as <Data Entry User> successfully logged out
from Argus Safety
Application.
successfully.
Result column.
it.
Review’ state.
Review’ state

Case Processing and
Workflow


“Route to Next State” as ‘Medical
Review’
dialog. successfully.

dialog appears.
<Quality Review User> from Argus Safety
Application.
58. Login to Argus Safety Application <Medical Review See associated Test Script Execution Form.
as a <Medical Review User> User> is able to login
successfully.
Result column.

Case Processing and
Workflow

{Test Case 01} is
displayed in search
following details:

Value:<{Test Case 01}> successfully.
Click on Search

select Accept Case
Verify Case Assigned To is

displayed as <Medical Review
User>
{Test Case 01} is
displayed in search
following details:
Filter: Case Number


in search results.

Case Processing and
Workflow

it.
Case is in ‘Medical
Verify that the case is in the ‘Medical Review’ state.
Review’ state
62. Medical Review See associated Test Script Execution Form

Go to Case Actions Medical Webpage dialog window
Review is opened
Case Medical Summary

Click on [Print Medical Summary] Report is opened in pdf
button. format.
Close Medical Summary Report. Case Medical Summary

Report is closed
Click on Cancel in Medical Review Medical Review

Webpage dialog window. Webpage dialog window
is closed.
following details:
Case is saved
Date Open: <Today’s date> successfully.
Code: CCORR
Group: Data Entry
Save the case

Case Processing and
Workflow


successfully.
dialog.

dialog appears.
65. Log out of Argus Safety Application See associated Test Script Execution Form
as <Medical Review
User> is successfully
<Medical Review User> logged out from Argus
Safety Application.
successfully.
Result column. User ID is recorded.
it.
Entry’ state.
Entry’ state

Case Processing and
Workflow

following details:
Case is saved
Date Open: <Today’s date> successfully.
Code: CCORR
Group: Data Entry
Save the case


successfully.
Review’
dialog.

dialog appears.
as <Data Entry User>. <Data Entry User> is
from Argus Safety
Application.

Case Processing and
Workflow

successfully.
it.
Review’ state.
Review’ state


successfully.
Review’
dialog.

dialog appears.
<Quality Review User> from Argus Safety
Application.

Case Processing and
Workflow

successfully.
it.
Case is in the ‘Medical
Review’ state.
Verify that the case is in the ‘Medical
Review’ state
On the Case Routing dialog, Case is closed
successfully.
“Route to Next State” as ‘Finalization’
dialog.

dialog appears.
78. Log out of Argus Safety Application <Medical Review See associated Test Script Execution Form.
as User> is successfully
logged out from Argus
<Medical Review User> Safety Application.

Case Processing and
Workflow

79. Login to Argus Safety Application <Finalization User> is See associated Test Script Execution Form.
as a <Finalization User> able to login
successfully.
Result column.
it.
Case is in the
Verify that the case is in the Finalization state.
‘Finalization’ state

In Action Items section enter case.
following details:

Code: Medical Review Required
Group: Medical Review
Save the case

Case is saved
successfully.

Case Processing and
Workflow

Review’
dialog. Case is closed
.
dialog appears.
83. Log out of Argus Safety Application <Finalization User> is See associated Test Script Execution Form.
as successfully logged out
from Argus Safety
<Finalization User> Application.
successfully.
Result column.
it.
Case is in ‘Medical
Verify that the case is in the ‘Medical Review’ state.
Review’ state

Case Processing and
Workflow

following details:

Code: Medical Review Required
Group: Medical Review
Case is saved
Save the case successfully.
dialog.

dialog appears.
88. Log out of Argus Safety Application <Medical Review See associated Test Script Execution Form.
as User> is successfully
logged out from Argus
<Medical Review User> Safety Application.

Case Processing and
Workflow

89. Login to Argus Safety Application <Finalization User> See associated Test Script Execution Form.
as a <Finalization User> is able to login
successfully.
it.
Case is in the
Finalization state.
Verify that the case is in the

existing action item with following
details:

Code: CCORR
Group: Data Entry
Case is saved

Case Processing and
Workflow

dialog
.

dialog appears.
<Finalization User> from Argus Safety
Application.
successfully.
Result column.
it.
Entry’ state.
Entry’ state

Case Processing and
Workflow

details:

Code: CCORR
Group: Finalization
Case is saved
.
dialog.

dialog appears.
98. Log out of Argus Safety Application <Data Entry User> is See associated Test Script Execution Form.
from Argus Safety
<Data Entry User> Application.

Case Processing and
Workflow

99. Login to Argus Safety Application <Finalization User> is See associated Test Script Execution Form.
as a <Finalization User> able to login
successfully.
Result column.
it.
Case is in the
Finalization state.

details:

Code: CCORR
Group: Finalization
Case is saved

Case Processing and
Workflow

.
“Route to Next State” as ‘Distribution’
dialog.

dialog appears.
from Argus Safety
<Finalization User> Application.
104. Login to Argus Safety Application <Distribution User> is See associated Test Script Execution Form.
as a <Distribution User> able to login
successfully.
it.
Case is in the
Distribution state.
‘Distribution’ state

Case Processing and
Workflow

Lock the case by clicking on Case locking pop up

icon window appears.
Case is locked
Enter user password and Notes as successfully.
testing and click on OK.
107. Go to Regulatory Reports tab. Regulatory Reports See associated Test Script Execution Form.
tab appears.
Click [Auto Schedule].
Reports are auto-
Verify following reports are auto- scheduled as
scheduled successfully: mentioned.
7D TGA INV FLT REL IB UNL to

(HA) TGA-IQVIA SNG
7D FDA INV FLT REL IB UN to

(HA) US FDA IND
7D IQVIA INV FLT REL IB UNL to

(INV) IQVIA

Case Processing and
Workflow

108. Left click on the status report icon The report is routed for See associated Test Script Execution Form.
for US FDA MedWatch 3500A approval.
Drug (HA) US FDA IND) and select
View Report Details.
When Report Details window
appears, navigate to the Routing
tab.
Click on [Route] button in order to

change ‘State’ field from
‘Generated’ to ‘Approved’ from the
dropdown. Enter comments
indicating “Approved for submission
as part of OPQ testing.”
Click [OK].
Case is saved
Save the case.
for US FDA MedWatch 3500A approval.
Drug (INV) IQVIA and select View
Report Details.

tab.

Dropdown. Enter comments
Click [OK].
Case is saved
Save the case.

Case Processing and
Workflow

for CIOMS-I (HA) TGA-IQVIA SNG approval.
and select View Report Details.

tab.

Dropdown. Enter comments
Click [OK].
Case is saved
Save the case.
111. Left click on the status report icon The report is submitted See associated Test Script Execution Form.
for US FDA MedWatch 3500A successfully.
Drug (HA) US FDA IND) and select
View Report Details.
tab.

change ‘State’ field from ‘Approved’
to ‘Submitted’ from the dropdown.
Enter comments indicating
“Approved for submission as part of
OPQ testing.”
Case is saved
Click [OK].
Save the case.

Case Processing and
Workflow

for US FDA MedWatch 3500 A successfully.
Drug (INV) IQVIA and select View
Report Details.

tab.

OPQ testing.”
Click [OK].
Case is saved
Save the case.
for CIOMS-I (HA) TGA-IQVIA SNG successfully.
and select View Report Details.

tab.

OPQ testing.”
Click [OK]. Case is saved
Save the case.

Case Processing and
Workflow

114. Click the Lock Case icon to unlock The case is unlocked, See associated Test Script Execution Form
the locked case. Enter the user’s updated, and is
password. available for editing.
Enter Notes as ‘Testing Case
Unlock’ when prompted.
(Take a screen shot).
Click [OK]
Click [Significant F/U]

The Significant F/U date
In the General tab, enter the is entered.
following date in the Follow-up
Received field: <Today’s date>.
Case is saved
Save the case. successfully.
115. Logged out successfully See associated Test Script Execution Form
Log out from Argus Safety from Argus Safety
Application Application

Case Processing and
Workflow
5. EXECUTION SUMMARY
By signing below, I indicate that I have executed each step of this document as instructed.
OVERALL TESTER EVALUATION OF SCRIPT(CHECK ONE) O PASS
O FAIL
Signature
of tester
General Observations:
By signing below, I indicate that I have reviewed this script and its attachments and I find it to be properly
executed.
ARE ALL EXPECTED RESULTS MET? (CHOOSE ONE) O YES
O NO
Signature
of Reviewer
Reviewer Comments:


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Case Processing and

DOC ID: Page 1 of 47

Revision Revision Notes Revised By Date

0 Initial version Nisha Verma 22 Mar 2022

DOC ID: Page 2 of 47

Test Number OPQ

1.14.1 5.2.1 5.3.1 5.4.1 5.5.1 5.6.1

Test Objective Verify all the requirement listed in above section.

DOC ID: Page 3 of 47

1. Following user account should be available to the tester:

Test Inputs N/A

Test Outputs Screenshots

Test data Refer Datasheet:

DOC ID: Page 4 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

Username: <Triage User> <Triage User> is able

Click on Login button

Record the User ID in the Actual

(Take a screen shot)

DOC ID: Page 5 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

Click on Select button besides

Click on Select in Clinical Trial

(Take a screen shot)

DOC ID: Page 6 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

(Take a screen shot)

DOC ID: Page 7 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

Verify Case Number is displayed in Case Number is

Click and try to edit Case Number.

Verify User is not able to modify case User is not able to

(Take a screen shot)

6. See associated Test Script Execution Form.

DOC ID: Page 8 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

Save the case Case save webpage

8. See associated Test Script Execution Form.

On the Case Routing dialog,

Notes: Click on OK if the Case save

9. See associated Test Script Execution Form.

DOC ID: Page 9 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

General section: Clinical Trial Selection

Click on Select button besides

Click on Select in Clinical Trial

Replace Product Name with ‘ERAS-

Click On [Search] button

{Test Case 01} is

(Take a screen shot)

DOC ID: Page 10 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

(Take a screen shot)

(Take a screen shot)

DOC ID: Page 11 of 47

Step Instruction Expected Results Actual Pass/ Initials/Date

Filter: Case Number Case is accepted

Right click on Search Result and

Verify Case Assigned To and