User Acceptance Testing Guide

and Templates
User Acceptance Test Plan

Action Date completed

System Version number, Protocol and Sponsor Identification

and your standard good documentation requirements
according to your company’s SOP.

Document names that support the UAT. Section

Numbers/Titles showing what you are testing against

List the names of each test case you created

List the names/titles of your team members who will be

executing the test cases

List how test steps that pass should be documented versus

steps that fail. List how you will track any findings which
need to be discussed with the vendor

Specific testing instructions for the testers including how to

log in to the testing environment. In addition, indicate
whether the tests will be printed out/and wet-ink to update
the tests or whether it will be electronically executed. Be
specific regardless how the test cases are being completed
and how screen prints will be managed.

Approval section to be signed prior to executing the UAT.

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Test Cases
Each test case should include the following:

Action Notes

Any instructions for the tester that may or may not have been
included in your UAT Test Plan

System Version number, Test Cycle number

The purpose of the test -- the specific function or rule you are
testing to be sure the system is working properly. (You can also
include a reference to the supporting document and the
sections which are being tested.) For example:
To confirm the system enforces collection of valid subject
information when screening a new subject. See User
Requirements Specification, section 3.

Start listing each step/action the tester needs to perform and

number your steps. This should include whether the tester will
need to create the patient in the test system or if it has
already been preselected for the test. For example:
Create a subject which has the status of Screened. Select
Male as gender and 01 Jan 1985 as the DOB.

Each action being tested, needs to have an Expected Result.

For example:
Test subject has been created

Each Expected Result should then indicate if the step Passed or

Failed

The last page of the test case should include:

a. System Version number, Test Cycle number
b. Total number of test steps
c. Total number of test steps passed and failed
d. A section where you can provide comments on any steps
which failed
e. Section for the tester to sign and date the test
Optional - if you are having a second team member reviewing
the test case, provide a second signature line for the person
who reviews the test

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UAT Summary Report
Include the following sections in your UAT Summary Report:

Action Notes
System Version number, Protocol and Sponsor Identification,
and your standard good documentation requirements
according to your company’s SOP.
Dates on which each test cycle was started and completed
Name the staff which executed test cases
List the status of each test case in each test cycle and
whether any action was required, for example, Test Cycle 1,
Test Case - Screening - Passed - no action required
Repeat the same for any additional test cycles
Approvals Section which includes a statement: I have
reviewed all executed test cases required for the study and
confirmed that both tester and reviewer signatures are
present. This system may be released for Production.

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Templates and Samples

User Acceptance Test Plan

This UAT Plan is to test the system described below:

Sponsor

Protocol ID

System Vendor

System Name

Verision

Documents supporting this UAT include:

• User Requirements Specification r# approved on YYYY-MM-DD
• Project Specification r# approved on YYYY-MM-DD
• List any of your company's SOPs that list any requirements for UAT

The following test cases are used to test this system:

• TestCaseName01
• TestCaseName02
• TestCaseName03
• ...

The following people will execute test cases:

• Name, Title
• Name, Title
• Name, Title

Tester Instructions
When executing each test case, the tester will record "Pass" or "Fail" for each step
based on the following criteria:
• If the actual results match the expected results, write the word “Pass”.
• If the actual results do not match the expected results write the word “Fail”
and record the step number on the last page of this test case.

Add any specific instructions particular for your company.

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Results will appear in the UAT Summary Report

Approval

I approve this User Acceptance Test Plan and supporting documents. User
Acceptance Testing may begin.

Tester Signature:

Digital Signature is in the Final PDF revision of this document

Signature Date

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UAT Test Case Template

Notes One of the following options should be recorded in the Pass/Fail

column for each Step:
• If the actual results match the expected results, write the word
“Pass”.
• If the actual results do not match the expected results write the
word “Fail” and record the step number on the last page of this
test case.

Revision History
VLIRT Project Document Date Revision
Version Version Revision Approved Revision

3 1 0 18 March 2021 Original Document

Test Case Execution Prep Add any preparatory steps here. For example:
• users needing to be added or email address updated
• subjects needing to be added or be at a certain status
• shipments or kits needing to be in a certain state
• These will be "steps" that are not “Passed” or “Failed”, they are
to setup the necessary scenario to be able to confirm the
function of requirements being tested

Purpose: Test Cycle:

To confirm that …ADD appropriate text to explain to a tester the purpose of the
test case. Example: To confirm a clinical site can be added to and activated in the
system.

Step Action Expected Results Pass/Fai

# l

1. Login as a user having the Clinical _____ Completed

Project Manager role

2. Add Clinical Site XXX _____ Site XXX added

3. Activate Site XXX _____ Site XXX activated

4. Print Site Activated Notification/Email _____ Activation email printed and

attached to test case

5. On the Sites page _____ Confirmed

Confirm Site XXX Activated = True

6. Logout _____ Completed

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Test Case Summary and Signature Page

# Steps # Steps
Version Test Cycle Total # Steps Executed # Steps Passed Failed

List of Steps Failed:

List Steps or NA

List of Steps with

Comments:
List Steps or NA

List of Steps with

Screenshots:
List Steps or NA

I confirm that I have executed this test case following the instructions
provided for each step above and in accordance with the Testing Instructions

Tester Signature:

Digital Signature is in the Final PDF revision of this document

Signature Date

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UAT Summary

Sponsor

Protocol ID

System Vendor

System Name

Verision

Test Cycle 1: started YYYY-MM-DD completed YYYY-MM-DD

Test Name/ID Tester Inits Results Actions Needed

Test Cycle 2: started YYYY-MM-DD completed YYYY-MM-DD

Test Name/ID Tester Inits Results Actions Needed

etc...

Approval
I have reviewed all executed test cases required for the study and confirmed
that both tester and reviewer signatures are present. This system may be
released for Production.

Tester Signature:

Digital Signature is in the Final PDF revision of this document

Signature Date

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About Veracity Logic, LLC

Veracity Logic (VL), based in North Carolina’s Research Triangle area, specializes in
providing subject and inventory management solutions using interactive response
technology (IRT) to support our clients' clinical trials.

At Veracity Logic, we’re as proud of our ability to manage the real-life demands of
clinical trials as we are of our technology. When you work with us, you’ll find that we
are reliable, responsive and user friendly -- we support your trial with our
experienced, helpful team that is dedicated to your success.

If you have comments or would like to learn more about how Veracity Logic can
support your next trial, please contact us at info@[Link].

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