Process Summary

E-Feasibility defines the following components:

Projects: A project in an E-Feasibility, a space assigned to the client in the TI instance. To create a project, users have to create a room in a multi-tenant eTMF application.

User Roles: E-Feasibility defines below mentioned roles for the users in a project:

• Administrator: Administrator has access to all functionalities and projects, including user permission management.
• Manager: The Manager has access to all the functionalities within a project
• Editor: Editor has the ability to create and edit forms in a project.
• Publisher: Publisher has the ability to send and review responses for created forms.
• Submitter: Submitter is a registered user contact with the ability to complete a survey within a system.

Categories: Categories in E-Feasibility are used to segregate questions and forms with particular shared characteristics under specific groups. E-Feasibility defines the following Categories:

• Question Category

• Form Types

Questions: Every form in a project consists of questions, which allow the user to conduct a survey for clinical research.

Sections in a Survey: Sections in a Survey divide questions into distinct parts. For example, in a Site Selection Questionnaire, below sections can be provided:

• Protocol
• Prior Information

• Staff and Site Profile

Response: Response is the answer to questions sent back by the Submitter or participants of the survey to the Publisher.

Settings: Settings are basic configurations required to create, publish, and complete Surveys in a project.

Reports: Reports are used to display the activities of the user in a project.

CDA: CDA is the Confidentiality Disclosure Agreement that the Sponsor/CRO and the Submitter agree upon and sign for Site feasibility