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RECORD NUMBER: PR25083 TITLE: PR25083 CLINICAL TRIALS DATA REQUEST VERSION: 1 Page 1 of 27

PR25083 CLINICAL TRIALS DATA REQUEST

AUTHOR: GOMATHY RAMACHANDRAN

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Approval Signatures
This project deliverable may be signed digitally. If digital signatures are used, they will be attached to the end of this document and this section will identify the names, roles and intent of the signatories. Otherwise, handwritten signatures will also be included in this section. Signatures Before Testing I have authored these test scripts to correctly represent the requirements and test acceptance criteria. Gomathy Ramachandran, Tester 31-July-2013

I have reviewed the content of this record and found that the planned test cases/scripts correctly represent the requirements and test acceptance criteria. Jane Shatskov, Business Sponsor DD-MMM-YYYY

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I have reviewed the content of this record and found that the planned test cases/scripts adhere to applicable testing procedures and processes. Amit Galgale, BT QA DD-MMM-YYYY Signature After Testing I attest that the test scripts have been executed in accordance with the applicable testing processes.

Maria McCauley Tester

24-SEP-2013

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Table of Contents
1 2 3 4 5 6 7 Approval Signatures............................................................................................................................................................................ 2 Introduction ......................................................................................................................................................................................... 5 Test Scripts.......................................................................................................................................................................................... 6 Screenshots (from testing) ................................................................................................................................................................ 21 Supporting References ...................................................................................................................................................................... 21 Revision History ............................................................................................................................................................................... 27 Appendices ........................................................................................................................................................................................ 27

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Introduction
This document describes the test steps required to meet the testing objective for the each corresponding requirement for PR25083

CLINICAL TRIALS DATA REQUEST

The overall objective of this test script is to ensure the following:

1. With respect to the changes done for IIR-Data Submissions, the existing process for Concept Submissions project creation and
task approvals should remain the same as it is today.

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Test Scripts
Objective
The overall objective of this test script is to ensure the following:

1. With respect to the changes done for IIR-Data Submissions, the existing process for Concept Submissions project creation and
task approvals should remain the same as it is today.

Prerequisites Test Script Setup Test Script # and Name: PR25083UATTestScript Module/Function/Unit: ACM IIR Functionality Requirement #: N/A Test Script Objective: The overall objective of this test script is to ensure the following:
1. With respect to the changes done for IIR-Data Submissions, the existing process for Concept Submissions project creation and task approvals should remain the same as it is today.

Build #: PR25083

Automated Script Name (if applicable): N/A

Setup for Test (hardware, software, prerequisite tests, data, timing, security): User set up is available and the user should be able to login to the system and create IIR Projects URL: https://primeuat.pfizer.com/Sourcing/Main/ Successful End Condition (Acceptance Criteria):
Upon successful completion of the Test Case the following will be proven true: 1. With respect to the changes done for IIR-Data Submissions, the existing process for Concept Submissions project creation and task approvals should remain the same as it is today.

Open Issues: None

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1.1 Complete IIR Concept creation

Step #

Instructions Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

Test Data 1. Click on Create IIR and Compound Grant Request 2. Assign the following values:
a. b. c. d. e. f. g. h. i. j. Type Of Request: IIR Submission Type: Concept Grant Requests: Drug Research Setting: Single-site Country Of Primary Site: United States Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Pre-clinical Title: <Give appropriate title> Click Create.

Expected Result

Deviations/ Comments

Pass/Fail/ Not Executed Pass

The project should successfully get created and status should now reflect Submitted

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

1.1(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase. 1. Open the Study Review Dform and fill up the Local section values as necessary and save the form. 2. Complete all the tasks in the Local Review Phase.
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The Submission Phase gets successfully completed and the project status should now reflect Local Review The Local Review Phase tasks get updated now. The Regional Review Phase appears.

Pass

1.1(contd .)

Complete Study Review Dform

Pass

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Step #

1.1(contd .)

Instructions Complete tasks in Regional Review Phase.

Test Data 1. Select the value Defer for Scientific Evaluation in the Regional section. 2. Complete all the required tasks in the Regional Review Phase

Expected Result The project status get updated as Deferred

Deviations/ Comments

Pass

1.2 Complete IIR Concept creation

Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

1. Click on Create IIR and Compound Grant Request 2. Assign the following values:
k. l. n. o. p. q. r. s. t. Type Of Request: IIR Submission Type: Concept Research Setting: Single-site Country Of Primary Site: United States Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Clinical Title: <Give appropriate title> Click Create.

m. Grant Requests: Funding

The project should successfully get created and status should now reflect Submitted

Pass

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

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Step #

1.2(contd .)

Instructions Complete Study Details Dform.

Test Data 1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

Expected Result The Submission Phase gets successfully completed and the project status should now reflect Local Review. The

Deviations/ Comments

Pass

1.2(contd .)

Local Review Phase appears.

Complete Study Review Dform and Local Review. Update the Regional Review section in Study Review Dform. Complete tasks in Regional Review Phase and Decline phase. 1. Open the Study Review Dform and fill up the Local Review section values as necessary and save the form.

The Local Review Phase tasks get updated and the Regional Review Phase appears now.

Pass

1.2(cond. )

1. Open the Study Review Dform and fill in the Regional Review section as necessary and save the form. 2. Enter the Scientific Evaluation as Decline for the Regional Review. 1. Complete all the required tasks in the Regional Review Phase 2. Complete all the required tasks in the Decline Phase The Decline Phase appears now and the project status should now reflect Declined Pass

1.2(contd .)

Pass

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1.3 Complete IIR Concept creation

Step #

Instructions Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

Test Data 1. Click on Create IIR and Compound Grant Request 2. Assign the following values:
a. b. c. d. e. f. g. h. i. j. k. Type Of Request: IIR Submission Type: Concept Grant Requests: Other Specify Other Grant Request Type : <Give appropriate value> Research Setting: Single-site Country Of Primary Site: United States Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Pre-clinical Title: <Give appropriate title> Click Create.

Expected Result

Deviations/ Comments

The project should successfully get created and status should now reflect Submitted Pass

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

1.3(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

The Submission Phase gets successfully completed and the project status should now reflect Local Review

Pass

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Step #

1.3(contd .)

Instructions Complete Study Review Dform

Test Data 1. Open the Study Review Dform and fill up the Local and section values as necessary and save the form. 2. Complete all the required tasks in the Local Review Phase. 1. Open the Review Dform and update Regional Scientific Evaluation to Defer 2. Complete all the required tasks in the Regional Review Phase

Expected Result The Local Review Phase tasks get updated and the Regional Review Phase appears now. The project status should now reflect Deferred

Deviations/ Comments

Pass

1.3(contd .)

Complete tasks in Local Review Phase, Regional Review Phase.

Pass

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2.1 Complete IIR Concept creation

Step #

Instructions Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

Test Data 1. Click on Create IIR and Compound Grant Request 2. Assign the following values:
a. b. c. d. e. f. g. h. i. j. Type Of Request: IIR Submission Type: Concept Grant Requests: Drug Research Setting: Single-site Country Of Primary Site: Canada Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Pre-clinical Title: <Give appropriate title> Click Create.

Expected Result

Deviations/ Comments

The project should successfully get created and status should now reflect Submitted Pass

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

2.1(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

The Submission Phase gets successfully completed and the project status should now reflect Local Review

Pass

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Step #

2.1(contd .)

Instructions Complete Study Review Dform

Test Data 1. Open the Study Review Dform and fill up the Local, section values as necessary and save the form.

Expected Result The Local Review Phase tasks get updated and the Regional Review Phase appears now. The project status now reflects Local Review.

Deviations/ Comments

Pass

2.1(contd .)

Complete the Local Review Phase

1. Complete all the required tasks in the Local Review Phase

Pass

2.1(contd .)

Complete the Regional Review Phase.

1. Open the Study Review Dform and fill up the Regional, section values as necessary and save the form. 2. Select the value of Decline for Global Scientific Evaluation and fill up the Global Review section. 3. Complete all the required tasks in the Regional Review.

The project status now reflects Regional Review.

Pass

2.1(contd .)

Complete tasks in Global Review Phase and Decline phase.

1. Complete all the required tasks in the Global Review Phase 2. Complete all the required tasks in the Decline Phase

The Decline Phase appears now and the project status should now reflect Declined

Pass

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2.2 Complete IIR Concept creation

Step #

Instructions Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

Test Data 3. Click on Create IIR and Compound Grant Request 4. Assign the following values:
a. b. c. d. e. f. g. h. i. j. Type Of Request: IIR Submission Type: Concept Grant Requests: Funding Research Setting: Single-site Country Of Primary Site: Australia Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Clinical Title: <Give appropriate title> Click Create.

Expected Result

Deviations/ Comments

Pass

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

2.2(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

The Submission Phase gets successfully completed and the project status should now reflect Local Review

PASS

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Step #

2.2(contd .)

Instructions Complete Study Review Dform

Test Data 1. Open the Study Review Dform and fill up the Local and Regional section values as necessary and save the form.

Expected Result The Local Review Phase tasks get updated and the Regional Review and Interest Phase appears now. The Interest Phase appears now and the project status should now reflect Interest

Deviations/ Comments

PASS

2.2(contd .)

Complete tasks in Local Review Phase, Regional Review Phase and Interest phase.

1. Complete all the required tasks in the Local Review Phase. 2. Complete all the required tasks in the Regional Review Phase 3. Complete all the required tasks in the Interest Phase

PASS

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2.3 Complete IIR Concept creation

Step #

Instructions Login with User ID: mccauleym and click on IIR and Compound Grant Request available in Create menu.

Test Data 1. Click on Create IIR and Compound Grant Request 2. Assign the following values:
a. b. c. d. e. f. g. h. i. j. k. l. Type Of Request: IIR Submission Type: Concept Grant Requests: Other Please Specify Other/Data Request Type : Test Research Setting: Single-site Country Of Primary Site: Germany Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Pre-clinical Title: <Give appropriate title> Primary Pfizer Drug : <Choose any value> Click Create.

Expected Result

Deviations/ Comments

PASS

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

2.3(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

The Submission Phase gets successfully completed and the project status should now reflect Local Review

PASS

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Step #

2.3(contd .)

Instructions Complete Study Review Dform

Test Data 1. Open the Study Review Dform and fill up the Local section values as necessary and save the form. 2. Complete all the required tasks in Local Review Phase,

Expected Result The Local Review Phase tasks get updated and the Regional Review and Interest Phase appears now. The Regional Review Phase tasks gets updated.

Deviations/ Comments

PASS

2.3(contd .)

Update the Regional Review section of the Review Dform. Complete all the tasks in Interest phase.

1. Open the Study Review Dform and fill up the Regional section values as necessary and save the form. 2. Complete all the required tasks in Regional Review Phase, 1. Complete all the required tasks in the Interest Phase.

PASS

2.3(contd .)

The Interest Phase appears and the project status should now reflect Interest.

PASS

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3.1 Complete IIR FollowOn project creation

Step #

Instructions Search for the project created in Step 1.1 and Open it.

Test Data 1. In the Overview page, Click on Actions and select Create Follow-on Project 2. Assign the following values:
a. b. c. d. e. f. g. h. i. j. k. l. Type Of Request: IIR Submission Type: Full Grant Requests: Other Please Specify Other/Data Request Type : Test Research Setting: Single-site Country Of Primary Site: <Choose any value> Primary Pfizer Therapeutic Area: <Choose any value> Secondary Pfizer Therapeutic Area: <Choose any value> Study Type: Pre-clinical Title: <Give appropriate title> Primary Pfizer Drug : <Choose any value> Click Create.

Expected Result

Deviations/ Comments

PASS

Capture screen shot of the newly created IIR Project and paste it in Section 4-Screenshots (from testing)

3.1(contd .)

Complete Study Details Dform.

1. Open the Study Dform and fill up all the required fields and save it. 2. Go to the Task section and complete all the tasks in the Submission Phase.

The Submission Phase gets successfully completed and the project status should now reflect Local Review

PASS

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Step #

3.1(contd .)

Instructions Complete Study Review Dform

Test Data 1. Open the Study Review Dform and fill up the Local section values as necessary and save the form. 2. Complete all the required tasks in Local Review Phase,

Expected Result The Local Review Phase tasks get updated and the Regional Review and Interest Phase appears now. The Regional Review Phase tasks gets updated.

Deviations/ Comments

PASS

3.1(contd .)

Update the Regional Review section of the Review Dform. Complete tasks in Decline phase.

1. Open the Study Review Dform and fill up the Regional section values as necessary and save the form. 2. Select the value of Decline for the scientific evaluation. 3. Complete all the required tasks in Regional Review Phase, 1. Complete all the required tasks in the Decline Phase

PASS

3.1(contd .)

The Decline Phase appears and the project status should now reflect Declined

PASS

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Test Script Summary Pass ( X ) Fail ( ) Not Executed ( ) Deviation Summary: Executed By: Maria McCauley Date: 24-SEP-2013 Reviewed By: Test Environment : Prime UAT Run #: 1 Total Pages of Supporting Evidence:

Re-Execution Required? Yes( ) No ( ) Date:

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Screenshots (from testing)

Step 1.1

Step 1.2

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Step 1.3

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Step 2.1

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Step 2.2

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Step 2.3

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Step 3.1

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Supporting References
Record Number N/A Reference Title N/A

Revision History
Version 1.0 Author Gomathy Ramachandran Date 31-May-2013 Revisions Initial Version Created

Appendices
Appendix N/A Appendix Name N/A

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