TMF roles and permissions use cases

  • Published by Viedoc System 2025-03-26
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Note! This page contains information and instructions for the new TMF user interface. If you are using the old interface, please go to the relevant user guides:

Want to browse more information for the new interface? Please go to the new TMF user guides:

Introduction

This lesson contains scenarios and frequently asked questions about roles and permissions in Viedoc TMF. For detailed information and explanations about roles and permissions, please see Roles and permissions in Viedoc TMF.

Scenarios and use cases

The following table contains examples of common use case scenarios together with the requisites for performing them.

Scenario Requisites
Drop zone: As a General site user, I want to be able to drop site-generated or site-signed records in the drop zone.
  • The user is invited to a clinic role for a specific site.
  • The TMF role mapped has NO ACCESS for all levels and artifacts.
eISF: As a General site user, I want to be able to file pre-defined records on site level, view some artifacts on study and country levels and archive the Investigator site TMF/eISF.
  • The user is invited to a clinic role for a specific site.
  • The TMF role mapped has WRITE access to pre-defined artifacts on site level, READ access to pre-defined artifacts on Study level and Country level. The role sheet Site staff can act as a starting point.
  • The TMF role mapped has the permission Archive investigator TMF.
  • Artifact is Optional or Required in the sheet Viedoc Extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.
As a Project manager, I want to be able to file records at study level, view all sponsor-side records at all levels in the study, archive the TMF (sponsor side), download the audit trail, and see the TMF settings and structure.
  • The user is invited to a clinic role that has a mapped TMF role with WRITE access to Study and READ access to Country and Site in the role sheets. Role SPONSOR-STUDY can act as a starting point.
  • The user needs to be invited on study level (All sites) in Viedoc to gain WRITE access. Otherwise, the WRITE permission will be translated to READ.
  • The user is invited to a clinic role that has the mapped TMF permissions Archive sponsor TMF, Download audit trail, and Read-only Trial Master File.
  • Artifact is Optional or Required in the sheet Viedoc extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.
As a Monitor, I do not have access to patient information records on site level. I file site-level records that belong on the sponsor-side TMF, view records for my country and the study, manage drop zone records, and review site-level records.
  • The user is invited to a clinic role that has a mapped TMF role with WRITE access to Site and READ access to Country and Study in the role sheets. The sheet Role SPONSOR-SITE can act as a starting point.
  • The user is invited to a clinic role that has a TMF role with REVIEW access to all artifacts that the review is to be performed on. The sheet Role SPONSOR-REVIEWER can act as a starting point.
  • The user needs to be invited to all applicable sites in Viedoc.
  • The user is invited to a clinic role that has the mapped TMF permission Manage drop zone.
  • Artifact is Optional or Required in the sheet Viedoc extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.
As a Country Manager or a Trial Manager, I want to be able to file records at country level, view all sponsor-side records at all levels in the study, and review all sponsor-side records.
  • The user is invited to a clinic role that has a mapped TMF role with WRITE access to Country and READ access to Study and Site in the role sheets. The sheet Role SPONSOR-COUNTRY can act as a starting point.
  • The user is invited to a clinic role that has a TMF role with REVIEW access to all artifacts that the review is to be performed on. The sheet Role SPONSOR-REVIEWER can act as a starting point.
  • The user needs to be invited on study level (All sites) in Viedoc to gain REVIEW access to all records per the role sheet. Otherwise, the REVIEW permission will be translated to READ.
  • Artifact is Optional or Required in the sheet Viedoc extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.
As a Regulatory Inspector, I want to have read-only access to all records (sponsor side and investigator side), TMF settings, and access to the audit trail.
  • The user is invited to a clinic role that has the mapped TMF permission Read-only Trial Master File, Read-only TMF Admin and Download audit trail.
  • The user needs to be invited on study level (All production sites) in Viedoc.
  • Artifact is Optional or Required in the sheet Viedoc extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.
As an Unblinded Statistician, I want to view, file, and classify blinded records only on all levels.
  • The user is invited to a clinic role that has a mapped TMF role with WRITE and READ access to unblinded artifacts in the role sheets. The sheet Role SPONSOR-UNBLINDED can act as a starting point.
  • The user needs to be invited on study level (All sites) in Viedoc to gain WRITE access to all records per the role sheet. Otherwise, the WRITE permission will be translated to READ.
  • Artifact is Optional or Required in Viedoc extensions, as Not Permitted in Viedoc extensions will override any permission in the role sheets to NO ACCESS.

Frequently asked questions

Why can't the end user see the artifact?

Check To resolve
Check that the user is invited to a clinic role with a mapped TMF role with at least Read to the artifact at the expected level. Invite the user to a clinic role with a mapped TMF role with read/write permissions to the artifact or edit the roles and accesses for the artifact in TMF Admin maintenance mode.
Check that the artifact itself is Optional or Required at the expected level, as Not permitted records will override any role access for the artifact. Edit the trial/country/site level settings for the artifact in TMF Admin maintenance mode.

Why can the end user see the artifact but not upload or edit?

Check To resolve
Check that the user is invited to a clinic role with a mapped TMF role with Write access to the artifact at the expected level. Invite the user to a clinic role with a mapped TMF role with write permission to the artifact or edit the roles and accesses for the artifact in TMF Admin maintenance mode.
Check that the user is invited to a clinic role on at least Country level (for write permission to Country level records) or Study level, All production sites (for write permission to Study level records), otherwise Write will be translated to Read. Invite the user to a clinic role on at least Country level (for write permission to Country level records) or Study level, All production sites (for write permission to Study level records).

Why can the end user see the artifact but not review or approve?

Check To resolve
Check that the user is invited to a clinic role with a mapped TMF role with Review access to the artifact at the expected level. Invite the user to a clinic role with a mapped TMF role with review permission to the artifact or edit the roles and accesses for the artifact in TMF Admin maintenance mode.
Check that the user is invited to a clinic role on at least Country level (for review permission to Country level records) or Study level, All production sites (for review permission to Study level records, otherwise Review will be translated to Read. Invite the user to a clinic role on at least Country level (for write permission to Country level records) or Study level, All production sites (for write permission to Study level records).

Why can the end user only see their own records in the drop zone?

Check To resolve
Check that the user is invited to a clinic role with a mapped TMF permission Manage drop zone. Map the Manage drop zone permission to the applicable clinic role.

Why can the end user manage the drop zone records but not see applicable artifacts or not choose the wanted TMF level when classifying the record?

Check To resolve
Check that the user is invited to a clinic role with a mapped TMF role with Write access to the artifact at the expected level. Invite the user to a clinic role with a mapped TMF role with write permission to the artifact or edit the roles and accesses for the artifact in TMF Admin maintenance mode.
Check that the user is invited to a clinic role on at least Country level (for write permission to Country level records) or Study level, All production sites (for write permission to Study level records, otherwise Write will be translated to Read. Invite the user to a clinic role on at least Country level (for write permission to Country level records) or Study level, All production sites (for write permission to Study level records).

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