eTMF access use cases

Study roles, eTMF roles, and permissions

The following table lists a number of tasks that study users can face, together with the eTMF roles, the Viedoc Clinic site groups, and the eTMF level access that they would need to perform the respective task.

For more information about site groups, see Managing users and Managing study sites.

Study role	Task	eTMF role	Viedoc Clinic site group	eTMF level access	Permissions	Comments
Study coordinator General site user	Drop documents in the shared drop zone	Site staff - customized with no access for all artifacts	Site	No access to all artifacts	None
Study coordinator General site user	View, file, and classify site-level documents, view some artifacts on country and study levels, archive the Investigator site TMF	Site staff	Site	Write access to pre-defined artifacts on site level, read access to pre-defined artifacts on study, site, and country levels	1. Archive Investigator TMF
Project manager	File study-level documents, view all sponsor-side documents, archive the sponsor TMF, download audit trail, and see TMF settings and structure	Sponsor study	All production sites*		1. Download audit trail 2. Archive sponsor TMF 3. Read-only TMF Admin	*Clinic access needs to be on study level and not every site one by one, otherwise the write permission will be translated to read permission.
Monitor	File site-level documents, view all documents for the study, my country, and my site, manage drop zone documents, review site level documents	Sponsor site Reviewer*	Site**	Write and review access on site level Read access on all levels	1. Manage drop zone	Although the role sheet grants review rights for study and country level documents too, the end user will only have read rights to those documents, as long as they are not invited on study or country level for their clinic role. *Clinic access needs to be given to all applicable sites.
Country manager Trial manager	File country-level documents, view all sponsor-side documents at all levels and review all documents	Sponsor country Reviewer	All production sites*			*Clinic access needs to be on study level and not every site one by one, otherwise the review permission will be translated to read permission.
Read-only role Regulatory inspector	Read-only access to all documents* and settings Access to audit trail	No role, permissions only	All production sites**		1. Read-only Trial Master File* 2. Read-only TMF Admin 3. Download audit trail	If read-only Trial Master File permission is assigned, any NO ACCESS permission will be overridden by read access by the system. This means that all artifacts set as optional or required (including blinded and investigator-side artifacts) will be visible. These permissions should be reserved for a role that requires all access, such as a regulatory inspector. *Clinic access needs to be on study level and not every site one by one, otherwise the review permission will be translated to read permission.
Unblinded role Sponsor or statistician	View, file, and classify blinded documents only on all levels	Sponsor unblinded	All production sites*	Write access to blinded documents on study level and site level (when applicable) No access to non-applicable documents on all levels	1. Download audit trail	*Clinic access needs to be on study level and not every site one by one, otherwise the review permission will be translated to read permission.

Scenarios

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 documents in the drop zone.	The user is invited to a clinic role for a specific site. The eTMF 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 documents 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 eTMF 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 eTMF 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 documents at study level, view all sponsor-side documents 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 eTMF 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 eTMF 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 documents on site level. I file site-level documents that belong on the sponsor-side TMF, view documents for my country and the study, manage drop zone documents, and review site-level documents.	The user is invited to a clinic role that has a mapped eTMF 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 an eTMF 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 eTMF 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 documents at country level, view all sponsor-side documents at all levels in the study, and review all sponsor-side documents.	The user is invited to a clinic role that has a mapped eTMF 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 an eTMF 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 documents 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 documents (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 eTMF 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 documents only on all levels.	The user is invited to a clinic role that has a mapped eTMF 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 documents 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 eTMF role with at least Read to the artifact at the expected level.	Invite the user to a clinic role with a mapped eTMF 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 documents 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 eTMF role with Write access to the artifact at the expected level.	Invite the user to a clinic role with a mapped eTMF 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 documents) or Study level, All production sites (for write permission to Study level documents), 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 documents) or Study level, All production sites (for write permission to Study level documents).

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 eTMF role with Review access to the artifact at the expected level.	Invite the user to a clinic role with a mapped eTMF 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 documents) or Study level, All production sites (for review permission to Study level documents, 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 documents) or Study level, All production sites (for write permission to Study level documents).

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

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

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

Check	To resolve
Check that the user is invited to a clinic role with a mapped eTMF role with Write access to the artifact at the expected level.	Invite the user to a clinic role with a mapped eTMF 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 documents) or Study level, All production sites (for write permission to Study level documents, 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 documents) or Study level, All production sites (for write permission to Study level documents).