Software Validation Report
Electronic Data Capture
Clinical Data Management System
Table of contents
Objectives and scope of application 3
Software life cycle overview 5
Software life cycle activities 17
...
Objectives and Scope of application
...
Software name | Electronic Data Capture / Clinical Data Management System: CheckPad |
General description | CheckPad is a Clinical Data Management and Electronic Data Capture System that helps to optimize clinical study processes and provide the best user experience. |
Scope of application | Establish studies and manage all data throughout the execution process. Support users in all relative tasks with clear systematic permission granted from study conductor to study participant. |
Product information | CheckPad is a system that allows storage and management of all data throughout the clinical study process. The system is developed with these following main features:
|
Overall requirements |
|
Role/Responsibility
...
Role/Responsibility | Title and Name | Initials |
System Owner | Founder Hieu Dao Dinh | HieuDD |
System Administrator | ||
Application Administrator | ||
System User | All team | |
Quality responsible | ||
Requirement/BA team | Technicians: Thang Vu Xuan Anh Mai Thach Viet Testers: Thao Ngo Thi Nhung Phung Thi Tuyet | ThangVX AnhMTV ThaoNT NhungPTT |
Design team | Designers Duong Mai Thuy Hieu Dao Dinh | DuongMT HieuDD |
Development team | Technicians Thang Vu Xuan Anh Mai Thach Viet Linh Tang Manh Tien Luu Quang Minh Vuong Dang | ThangVX AnhMTV LinhTM TienLQ MinhVD |
Testing team | Testers Thao Ngo Thi Nhung Phung Thi Tuyet | ThaoNT NhungPTT |
Type of software
...
Type of software | Source software |
☑Application software ☐System software ☐Programing software ☐Driver software | ☑Closed source software ☐Open source software |
Software life cycle overview
Version 1.0-1.1
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.0 – V1.1
...
Task
...
Requirements specification
...
ThangVX
AnhMTV
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
...
Design and implementation
...
Task
...
Design and development planning
HieuDD
...
Method
...
Peer review
...
Task
...
Design
...
DuongMT
...
Method
...
Peer review
...
HieuDD
...
Check
...
Design approved
...
HieuDD
...
Coding
...
Task
...
Coding
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Task
...
Unit test
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
ThaoVT
...
Method
...
Peer review
...
ThangVX
ThaoVT
...
Check
...
Test plan approved
...
ThangVX
...
Task
...
Test case
...
ThaoVT
...
Method
...
Peer review
...
ThangVX
...
Check
...
Test report/ Test approved
...
ThaoVT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
ThangVX
...
Method
...
Peer review
...
AnhMTV
HieuDD
LinhTM
TienLQ
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
...
ThaoVT
...
Task
...
System acceptance test preparation
...
ThangVX
ThaoVT
HieuDD
...
Method
...
System acceptance test
...
ThaoVT
...
Check
...
System acceptance test approved
...
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
ThangVX
...
Method
...
Peer review
...
HieuDD
Version 1.2
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.2
...
Task
...
Requirements specification
...
ThangVX
AnhMTV
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
...
Design and implementation
...
Task
...
Design and development planning
HieuDD
...
Method
...
Peer review
...
Task
...
Design
...
DuongMT
...
Method
...
Peer review
...
HieuDD
...
Check
...
Design approved
...
HieuDD
...
Coding
...
Task
...
Coding
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Task
...
Unit test
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
ThaoVT
...
Method
...
Peer review
...
ThangVX
ThaoVT
...
Check
...
Test plan approved
...
ThangVX
...
Task
...
Test case
...
ThaoVT
...
Method
...
Peer review
...
ThangVX
...
Check
...
Test report/ Test approved
...
ThaoVT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
ThangVX
...
Method
...
Peer review
...
AnhMTV
HieuDD
LinhTM
TienLQ
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
...
ThaoVT
...
Task
...
System acceptance test preparation
...
ThangVX
ThaoVT
HieuDD
...
Method
...
System acceptance test
...
ThaoVT
...
Check
...
System acceptance test approved
...
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
ThangVX
...
Method
...
Peer review
...
HieuDD
Version 1.3
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.3
...
Task
...
Requirements specification
...
ThangVX
AnhMTV
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
...
Design and implementation
...
Task
...
Design and development planning
...
ThangVX
HieuDD
...
Method
...
Peer review
...
Task
...
Design
...
ThangVX
...
Method
...
Peer review
...
HieuDD
...
Check
...
Design approved
...
HieuDD
...
Coding
...
Task
...
Coding
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Task
...
Unit test
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Method
...
Peer review
...
AnhMTV
ThangVX
LinhTM
TienLQ
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
NhungPTT
...
Method
...
Peer review
...
ThangVX
...
Check
...
Test plan approved
...
ThangVX
...
Task
...
Test case
...
NhungPTT
...
Method
...
Peer review
...
ThangVX
...
Check
...
Test report/ Test approved
...
NhungPTT
...
Task
...
Test performance
...
N/A
...
Method
...
Test report
...
ThaoNT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
ThangVX
...
Method
...
Peer review
...
AnhMTV
LinhTM
TienLQ
NhungPTT
HieuDD
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
NhungPTT
...
Task
...
System acceptance test preparation
...
ThangVX
...
Method
...
System acceptance test
...
NhungPTT
...
Check
...
System acceptance test approved
...
NhungPTT
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
ThangVX
...
Method
...
Peer review
...
HieuDD
Version 1.4
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.4
...
Task
...
Requirements specification
...
ThangVX
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
...
Design and implementation
...
Task
...
Design and development planning
...
MinhVD
LinhTM
...
Method
...
Peer review
...
Task
...
Design
...
ThangVX
...
Method
...
Peer review
...
ThangVX
MinhVD
LinhTM
...
Check
...
Design approved
...
ThangVX
...
Coding
...
Task
...
Coding
...
LinhTM
MinhVD
...
Method
...
Peer review
...
LinhTM
MinhVD
ThangVX
...
Task
...
Unit test
...
LinhTM
MinhVD
ThangVX
...
Method
...
Peer review
...
ThangVX
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test plan approved
...
NhungPTT
...
Task
...
Test case
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test report/ Test approved
...
NhungPTT
...
Task
...
Test performance
...
N/A
...
Method
...
Test report
...
NhungPTT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
ThangVX
...
Method
...
Peer review
...
NhungPTT
LinhTM
MinhVD
HieuDD
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
NhungPTT
...
Task
...
System acceptance test preparation
...
ThangVX
...
Method
...
System acceptance test
...
NhungPTT
...
Check
...
System acceptance test approved
...
NhungPTT
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
MinhVD
LinhTM
...
Method
...
Peer review
...
HieuDD
Version 1.5
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.5
...
Task
...
Requirements specification
...
ThangVX
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
...
Design and implementation
...
Task
...
Design and development planning
...
HieuDD
ThangVX
...
Method
...
Peer review
...
Task
...
Design
...
HieuDD
...
Method
...
Peer review
...
ThangVX
...
Check
...
Design approved
...
HieuDD
...
Coding
...
Task
...
Coding
...
ThangVX
LinhTM
...
Method
...
Peer review
...
ThangVX
LinhTM
...
Task
...
Unit test
...
ThangVX
LinhTM
...
Method
...
Peer review
...
ThangVX
LinhTM
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test plan approved
...
NhungPTT
...
Task
...
Test case
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test report/ Test approved
...
NhungPTT
...
Task
...
Test performance
...
N/A
...
Method
...
Test report
...
NhungPTT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
ThangVX
...
Method
...
Peer review
...
NhungPTT
HieuDD
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
NhungPTT
...
Task
...
System acceptance test preparation
...
ThangVX
...
Method
...
System acceptance test
...
NhungPTT
...
Check
...
System acceptance test approved
...
NhungPTT
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
ThangVX
NhungPTT
...
Method
...
Peer review
...
HieuDD
Version 1.6
...
Version
...
Activity
...
Requirements and system acceptance test specification
...
Date/ Initials
...
V1.6
...
Task
...
Requirements specification
...
ThangVX
...
Method
...
Peer review
...
Check
...
Requirements specification approved
...
HieuDD
AnhMTV
NhungPTT
...
Design and implementation
...
Task
...
Design and development planning
...
HieuDD
AnhMTV
...
Method
...
Peer review
...
Task
...
Design
...
HieuDD
...
Method
...
Peer review
...
AnhMTV
ThangVX
NhungPTT
...
Check
...
Design approved
...
HieuDD
...
Coding
...
Task
...
Coding
...
AnhMTV
ThangVX
...
Method
...
Peer review
...
AnhMTV
ThangVX
...
Task
...
Unit test
...
AnhMTV
ThangVX
...
Method
...
Peer review
...
AnhMTV
ThangVX
...
Check
...
Deploy to test environment
...
ThangVX
...
Inspections and testing
...
Task
...
Test plan
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test plan approved
...
NhungPTT
...
Task
...
Test case
...
NhungPTT
...
Method
...
Peer review
...
NhungPTT
...
Check
...
Test report/ Test approved
...
NhungPTT
...
Task
...
Test performance
...
N/A
...
Method
...
Test report
...
NhungPTT
...
Installation and system acceptance test
...
Task
...
Installation plan
...
HieuDD
ThangVX
...
Method
...
Peer review
...
AnhMTV
HieuDD
...
Check
...
Installation plan approved
...
HieuDD
...
Method
...
Verification and test of installation
...
NhungPTT
...
Task
...
System acceptance test preparation
...
ThangVX
AnhMTV
NhungPTT
...
Method
...
System acceptance test
...
NhungPTT
...
Check
...
System acceptance test approved
...
NhungPTT
HieuDD
...
Performance, servicing, maintenance, phase out
...
Task
...
Phase out
...
AnhMTV
...
Method
...
Peer review
...
HieuDD
Software life cycle activities
Version 1.0-1.1
...
Version
...
Requirements and system acceptance test specification
...
Document/ Initials
...
V1.0 – V1.1
...
Features:
Setup Study
Create Study
Create CRF
Create Visit Definition
Create Subject Group Classes
Create Rules
Create Site
Assign User
Discrepancy Note
Data Set
Submit Data
Manage Rule
Manager User Schedule Visit
Manage User
...
Requirements specification
...
Software Requirement Specification: https://bit.ly/3vjcqJ9
...
Peer review
...
Requirements specification approved
...
Design and implementation
...
Design and development planning
...
Software Design Specification: https://bit.ly/3vhNDFk
...
Peer review
...
Design input
...
N/A
...
Peer review
...
Design approved
...
Coding
...
Coding
...
Build: xx – Build: xx
...
Peer review
...
Unit test
...
Peer review
...
Deploy to test environment
...
Inspections and testing
...
Test plan
...
...
Peer review
...
Test plan approved
...
Test case
...
...
Peer review
...
Test report/ Test approved
...
Test performance
...
N/A
...
Test report
...
...
Installation and system acceptance test
...
Installation plan
...
...
Peer review
...
Installation plan approved
...
Installation summary
...
Installation procedure
...
Verification and test of installation
...
System acceptance test preparation
...
System acceptance test
...
System acceptance test approved
...
Performance, servicing, maintenance, phase out
...
Phase out
...
N/A
...
Peer review
Version 1.2
...
Version
...
Requirements and system acceptance test specification
...
Document/ Initials
...
V1.2
...
New features:
Login
Forgot password
Access home với các User
My Profile
Manage Study Subject
Manage Study Visit
Manage Data
Source Data Verification
Study Audit Log
Rules
Groups
CRFs
CRF History
Notes and Discrepancies Note: Action for View within record
Extract Data:
Export Dataset
Export Case Book
...
Requirements specification
...
Requirement: https://bit.ly/3kdIkAv
State changes: https://bit.ly/37Q5zhn
...
Peer review
...
Requirements specification approved
...
Design and implementation
...
Design and development planning
...
Design requirement: https://bit.ly/37KiT6U
...
Peer review
...
Design approved
...
Design changes
...
N/A
...
Peer review
...
Coding
...
Coding
...
Build: xx – Build: xx
...
Peer review
...
Unit test
...
Peer review
...
Deploy to test environment
...
Inspections and testing
...
Test plan
...
...
Peer review
...
Test plan approved
...
Test case
...
...
Peer review
...
Test report/ Test approved
...
Test performance
...
N/A
...
Test report
...
...
Test case changes:
Update Status of the Study Visit
Update status of the Study Subject
...
Update Status of the Study Visit: https://bit.ly/3LgIlj0
Update status of the Study Subject: https://bit.ly/3vlJFvG
...
Peer review
...
Test approved
...
Installation and system acceptance test
...
Installation plan
...
...
Peer review
...
Installation plan approved
...
Installation summary
...
Installation procedure
...
Verification and test of installation
...
System acceptance test preparation
...
System acceptance test
...
System acceptance test approved
...
Performance, servicing, maintenance, phase out
...
Phase out
...
N/A
...
Peer review
Version 1.3
...
Version
...
5.1. Requirements and system acceptance test specification
...
Document/ Initials
...
V1.3
...
New features:
V1.3.1:
Task summary
V1.3.2:
eCRF Builder
Unit Dictionary
Response Set
V1.3.3
Randomization module
...
Requirements specification
...
V1.3.1: https://bit.ly/3EO5Cqh
V1.3.2: https://bit.ly/3KlFX9w
V1.3.3: https://bit.ly/3rTCvMT
...
Peer review
...
Requirements specification approved
...
Design and implementation
...
Design and development planning
...
N/A
...
Peer review
...
Design approved
...
Design changes
...
N/A
...
Peer review
...
Coding
...
Coding
...
Build: xx – Build: xx
...
Peer review
...
Unit test
...
Peer review
...
Deploy to test environment
...
Inspections and testing
...
Test plan
...
...
Peer review
...
Test plan approved
...
Test case
...
...
Peer review
...
Test report/ Test approved
...
Test report
...
...
Test case changes:
Update Manage CRFs
...
...
Peer review
...
Test approved
...
Installation and system acceptance test
...
Installation plan
...
...
Peer review
...
Installation plan approved
...
Installation summary
...
Installation procedure
...
Verification and test of installation
...
System acceptance test preparation
...
System acceptance test
...
System acceptance test approved
...
Performance, servicing, maintenance, phase out
...
Phase out
...
N/A
...
Peer review
Version 1.4
...
Version
...
Requirements and system acceptance test specification
...
Document/ Initials
...
V1.4
...
New features:
V1.4.0:
Payment Module
Two-step verification
Visual Report Page
Data Notification
V1.4.1:
Update Export Dataset
Update Discrepancies Note
Update SDV to Item Level
...
Requirements specification
...
V1.4.0: https://bit.ly/3vlpIVL
V1.4.1: https://bit.ly/3vNY1E0
...
Peer review
...
Requirements specification approved
...
Design and implementation
...
Design and development planning
...
N/A
...
Peer review
...
Design approved
...
Design changes
...
N/A
...
Peer review
...
Coding
...
Coding
...
Build: xx – Build: xx
...
Peer review
...
Unit test
...
Peer review
...
Deploy to test environment
...
Inspections and testing
...
Test plan
...
...
Peer review
...
Test plan approved
...
Test case
...
...
Peer review
...
Test report/ Test approved
...
Test report
...
...
Test case changes:
Update Export Dataset
Update Discrepancies Note
Update SDV
...
...
Peer review
...
Test approved
...
Installation and system acceptance test
...
Installation plan
...
...
Peer review
...
Installation plan approved
...
Installation summary
...
Installation procedure
...
Verification and test of installation
...
System acceptance test preparation
...
System acceptance test
...
System acceptance test approved
...
Performance, servicing, maintenance, phase out
...
Phase out
...
N/A
...
Peer review
Version 1.5
...
Version
...
Requirements and system acceptance test specification
...
Document/ Initials
...
V1.5
...
New features:
Basic features on Tablet App
Log in
Log out
Personal settings
Subject Matrix
Home Page
Discrepancies Note
Entry Data
...
Requirements specification
...
...
Peer review
...
Requirements specification approved
...
Design and implementation
...
Design and development planning
...
...
Peer review
...
Design approved
...
Design changes
...
N/A
...
Peer review
...
Coding
...
Coding
...
Build: xx – Build: xx
...
Peer review
...
Unit test
...
Peer review
...
Deploy to test environment
...
Inspections and testing
...
Test plan
...
...
Peer review
...
Test plan approved
...
Test case
...
...
Peer review
...
Test report/ Test approved
...
Test performance
...
N/A
...
Test report
...
...
Test case changes
...
N/A
...
Peer review
...
Test approved
...
Installation and system acceptance test
...
Installation plan
...
...
Peer review
...
Installation plan approved
...
Installation summary
...
Installation procedure
...
Verification and test of installation
...
System acceptance test preparation
...
System acceptance test
...
System acceptance test approved
...
Performance, servicing, maintenance, phase out
...
Phase out
...
Peer review
Version 1.6
Version
Requirements and system acceptance test specification
Document/ Initials
V1.6
New features:
Enable ePRO module
ePRO App
Requirements specification
Peer review
Requirements specification approved
Design and implementation
Design and development planning
Peer review
Design approved
Design changes
N/A
Peer review
Coding
Coding
Build: xx – Build: xx
Peer review
Unit test
Peer review
Deploy to test environment
Inspections and testing
Test plan
Peer review
Test plan approved
Test case
Peer review
Test report/ Test approved
Test performance
N/A
Test report
Test case changes
Peer review
Test approved
Installation and system acceptance test
Installation plan
Peer review
Installation plan approved
Installation summary
Installation procedure
Verification and test of installation
System acceptance test preparation
System acceptance test
System acceptance test approved
Performance, servicing, maintenance, phase out
Phase out
Conclusion
Conclusion: The modules are working as planned. | |
Signature: HieuDD ThangVX |