An overview of user roles and abilities

Marcos Bastidas -

All functionality in Smart Submit is governed by the role you are assigned. Below is an explanation of each role type and a short summary of their abilities.

 

ROLE DEFINITION ABILITIES
Clinical Research Coordinator (CRC) A researcher (i.e. research nurse or assistant) at a site who is responsible for uploading medical images, tracking their status, and answering queries.

- Can upload images

- Can withdraw images after submission

- Can reply to open queries

- Can only view data from their own site

- Can view performance metrics for their personal uploads and for their site (for trials they are enabled for)

Investigator The site investigator (typically an MD) at the site who manages the trial at the local level. 

- Can upload images

- Can withdraw images after submission

- Can reply to open queries

- Can only view data from their own site

- Can view performance metrics for their personal uploads and for any specific user at their site (for trials they are enabled for)

Clinical Specialist The Clinical Specialists work for the sponsor and ensures proper use of the medical technology in clinical applications.

- Can view case records and image transfer data from any site within the trials for which they are enabled.
- Can access images if user-level permissions granted.
- Stand alone trials only: Can add or inactivate CRCs and Investigators
- Cannot change the case status and data

Site Monitor The Clinical Research Associate assigned by the sponsor to monitor the activities of one or more research sites.

- Can view case records and non-image trial data from any site within the trials for which they are enabled, but not download actual images. Image download links can be requested from your Trial Manager or Data Manager.
- Stand alone trials only: Can add or inactivate CRCs and Investigators
- Cannot change the case status

Trial Manager/Data Manager The Trial Manager or Data Manager role manages the trial setup in SMART Submit.

- Can view case records image trial data from any site within the trials for which they are enabled.
- Stand alone trials only: TM/DM can add or inactivate CRCs, Investigators, Clinical Specialist, Site Monitors, and auditors. Additionally, TM can invite a DM, but not vice versa.
- Cannot change the case status.
- Can access images if user-level permissions granted.

Auditor The auditor role is for independent review of the data in the system. - Has "read only" access to all data from all sites within a trial for which they are enabled

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