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
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Objectives and Scope of application
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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:
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Overall requirements |
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Role/Responsibility
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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
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Type of software | Source software |
☑Application software ☐System software ☐Programing software ☐Driver software | ☑Closed source software ☐Open source software |
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