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:

• Build Study

• Build eCRF

• Entry Data

• Verify Data

• Sign Data

• Discrepancy Notes

• Export Data

• Visual Report

• Randomization module

• ePRO module

• ...

Overall requirements

• Sufficient features

• Friendly user interface

• Technical Stack:

• Frameworks & Library

  • Spring Framework

  • Spring MVC

  • Spring Security

  • Spring Security OAuth 2

  • Hibernate

  • Freemarker

  • Angular JS

  • JUnit 4, Spring Test, Spring DB Unit Test

  • …

• Database

  • PostgreSQL

  • Oracle (no longer supported

• Tools

  • Maven for project management

  • Bitbucket for source version control

  • …

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

Source software

☑Application software

☐System software

☐Programing software

☐Driver software

☑Closed source software

☐Open source software

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

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

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

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

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

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

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

https://bit.ly/3OQ8fMS  

Peer review

Test plan approved

Test case

https://bit.ly/3OHFge4  

Peer review

Test report/ Test approved

Test performance

N/A

Test report

https://bit.ly/3vkUwWk  

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

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

https://bit.ly/3EQ5iHj  

Peer review

Test plan approved

Test case

https://bit.ly/3vi740F  

Peer review

Test report/ Test approved

Test performance

N/A

Test report

https://bit.ly/3LnHrRZ  

Test case changes:

1. Update Status of the Study Visit

2. Update status of the Study Subject

1. Update Status of the Study Visit: https://bit.ly/3LgIlj0  

2. Update status of the Study Subject: https://bit.ly/3vlJFvG  

Peer review

Test approved

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

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

https://bit.ly/3LswjDu  

Peer review

Test plan approved

Test case

https://bit.ly/3LjIy4Y  

Peer review

Test report/ Test approved

Test report

https://bit.ly/36P5om2  

Test case changes:

1. Update Manage CRFs

https://bit.ly/38x5xv6  

Peer review

Test approved

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

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

https://bit.ly/3LB8s4B 

Peer review

Test plan approved

Test case

https://bit.ly/3ODwvBI  

Peer review

Test report/ Test approved

Test report

https://bit.ly/3MszcUG  

Test case changes:

1. Update Export Dataset

2. Update Discrepancies Note

3. Update SDV

https://bit.ly/3OAlW2p  

Peer review

Test approved

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

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

https://bit.ly/3vJcTTX  

Peer review

Requirements specification approved

Design and implementation

Design and development planning

https://bit.ly/3EYvIXG 

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

https://bit.ly/3rT7ito  

Peer review

Test plan approved

Test case

https://bit.ly/3OIE4XF  

Peer review

Test report/ Test approved

Test performance

N/A

Test report

https://bit.ly/3MBkACn  

Test case changes

N/A

Peer review

Test approved

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

Requirements and system acceptance test specification

Document/ Initials

V1.6

New features:

• Enable ePRO module

• ePRO App

Requirements specification

https://bit.ly/3KlrTgf  

Peer review

Requirements specification approved

Design and implementation

Design and development planning

https://bit.ly/3Kj7aJV 

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

https://bit.ly/3KdZCrX  

Peer review

Test plan approved

Test case

https://bit.ly/3EOwTso 

Peer review

Test report/ Test approved

Test performance

N/A

Test report

https://bit.ly/3xUbwoc  

Test case changes

Peer review

Test approved

Installation and system acceptance test

Installation plan

https://bit.ly/3KdWPit  

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

Conclusion: The modules are working as planned.

Signature: 

HieuDD

ThangVX