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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.

  • “Site view ePROM/CRF only” - Facilitates the access of site users for the collection of PROMS and CRFs only, blocks usage of the image upload functionality in UNITY.

API-Usage
  • As user of the API you need special permissions.

  • A complete overview over the ACLs to the API is here: QDICOM API |

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

Permission

Site User

Sponsor User

Description

Administrator

-

-

Can assign studies to users

Answer Query,

Assignable

Assignable

Allows opening, answering and resolving a query

Clinic Administration

-

Assignable

Provides the functionality of creating new Clinics

Data Monitor

-

Assignable

Allows the signing of PROM/CRF results as a data monitor to confirm correctness of the entered data.

Document read / write

Assignable

Assignable

Enables the UNITY module “Study documents”, where study documents (e.g., radiographic protocol, imaging instructions) can be shared.

Edit Validation Rule

Assignable

Assignable

Allows creating and editing of validation rules

FXA Analyst

-

-

FXA Results Reviewer

-

-

Hospital Administration

Investigator

Assignable

Assignable

Allows the signing of PROM/CRF results as a principal investigator to confirm correctness of the entered data.

Jenkin

-

-

Jenkins is an open source automation server. This tool is only accessable for IT.

Medical Coding

-

Assignable

Allows coding of answers in medical terms

Open Query

-

Assignable

Allows opening, answering and resolving a query

Parameter Designer

-

Assignable

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

Reference Designer

-

Assignable

Gives access to reference designer to enable the selection of exam periods that are to be compared or that are to be used as references. For FXA measurements only.

Reporting

Resolve Query

-

Assignable

Allows opening, answering and resolvin a query

Save Study Design

Assignable

Allows to save the study design under study designer, if study is ‘in planning’. Study Status can only be changes by administrator

Set NA Questionnaire Results

Assignable

Assignable

Adds the button “not available” as an alternative answer option to questoinnaires (currently KSW only)

Set Responsetime

Sign Full Dataset

Assignable

Assignable

Enables funcionality to sign a full set of questionnaires for all eximination periods of one patient

Site Email Texts

Allows modification of patient notifications.

Sponsor Administration

-

Assignable

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

-

Assignable

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

Study Designer

-

Assignable

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

Transcriber

Assignable

-

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.

User Administration

Assignable

Assignable

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

View PROM/CRF only

Assignable

-

Facilitates the access of site users for the collection of PROMS and CRFs only, blocks usage of the image upload functionality in UNITY.

View Validation Overview

Assignable

Assignable

Enables the Validation Overview

Xray Classifier

2D 3D CAD Registration

Role

Default Permissions

Description

upload scan

was genau kann der sponspor alles

was genau kann der site user alles

Updated on 13 Sep 2023

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