User Roles and Permissions

Aim

The purpose of this article is to explain the user roles and permissions in the UNITY Platform.

Explanations

User Roles

Users can be configured as 2 user roles: site users and sponsor users. The site role is suitable for users that enter data (patients, images, questionnaires) to a study in the UNITY Platform. The sponsor role is suitable for users who are responsible for monitoring activities in the study.

User Permissions

It is also possible to assign additional permissions to site and sponsor users in the UNITY Platform. These permissions allow the user to access further features in the UNITY Platform. The permissions available in the UNITY Platform for user configuration are listed and described below:

• “Document read / write” - Enables the UNITY module “Study documents”, where study documents (e.g., radiographic protocol, imaging instructions) can be shared.

• “Transcriber” - Allows the signing of PROM/CRF results as a specified data transcriber (transcription of paper-based collected data into UNITY) to confirm correctness of the entered data.

• “Data monitor” -Allows the signing of PROM/CRF results as a data monitor to confirm correctness of the entered data.

• “Investigator” -Allows the signing of PROM/CRF results as a principal investigator to confirm correctness of the entered data.

• “Sign Full Data Set” - Enables possibility to sign a full set of questionnaires for all eximination periods of one patient

• “Medical Coding” - Allows coding of answers in medical terms

• “Edit Validation Rule” - Allows creating and editing of validation rules

• “View Validation Overview” - Enables the Validation Overview

• “Open Query”, “Answer Query” and “Resolve Query” - Allows opening, answering and resolvin a query

• “Sponsor Administration” - Provides the functionality of the sponsor administration (“Sponsor Administration” menu item) to a sponsor user, if the study is designed independently of RAYLYTIC.

• “Study administration” - Provides the functionality of the study administration (“Study Administration” menu item), if the study is designed independently of RAYLYTIC.

• “User administration” - Provides the functionality of the user administration (“User Administration” menu item), if the user administration is organized independently of RAYLYTIC.

• “Clinic Administration” - Provides the functionality of creating new Clinics

• “Study designer” - Provides the functionality of the study designer (“Study Designer” menu item) to a sponsor user, if the study is designed independently of RAYLYTIC.

• “Parameter designer” - Provides the functionality of the parameter designer (“Parameter Designer” menu item) to a sponsor user, if the study is designed independently of RAYLYTIC.

• “View PROM/CRF only” - Facilitates the access of site users for the collection of PROMS and CRFs only, without the image upload functionality in UNITY.

Not all permissions can be assigned to both user roles. The table below lists which permissions can be assigned to each user role.

Updated on 13 Sep 2023