Study Configuration in Egnyte eTMF

Once a study has been created in Egnyte eTMF, a Study Manager or eTMF Administrator can update its settings on the Study Configuration screen. This page will walk users through the different settings in this section and how to use them.

Study Details

This tab is used for capturing plain text information about the study, and for managing some settings about how the study and its documents should behave. 

Study Information

This section contains the following fields to capture information about the study and inform some system behaviors in accordance with its details:

• Study Name: The name of the study within Egnyte eTMF, as displayed on the My Studies page and elsewhere. 
• CTMS Reference ID: An optional field to capture the study’s ID in an external CTMS system, for reference purposes.
• Drug/Device Name: An optional field to capture the name of the drug or device product.
• Description: An optional field to capture the description of the study.
• Study ID: An un-editable field to capture the Study ID as initially indicated during the study creation process. This field value informs the names of system-managed folders related to this study in Collaborate and elsewhere.
• Study Type: An un-editable field to capture the type of study (for example, device or non-device) as initially indicated during the study creation process. This field value informs what artifacts are applicable and available for configuration on the Artifact Configuration page. 
• Investigator-Initiated Study: An un-editable field to capture whether the study is investigator initiated during the study creation process. This field value informs what artifacts are applicable and available for configuration on the Artifact Configuration page. 
• eTMF Reference Model: An un-editable field which indicates that the starting point for the artifact configuration for that study is the eTMF Reference Model 3.1.0. This value is defined by Egnyte and cannot be changed, however the artifact configuration is always editable to users with permission.

Sponsor Information

This section contains optional fields to capture details about the study sponsor:

• Name
• Email
• Phone Number
• Organization Details

These fields can provide particular value to CROs who work with multiple study sponsors.

eTMF Administrator

This section contains optional fields to capture details about the eTMF administrator for a study:

• Name
• Email
• Phone Number

These fields can provide particular value to CROs who work with multiple study sponsors, each with their own eTMF administrator.

Quality Control

This section contains two settings related to the document review and approval process for a study. Learn more about Quality Control in eTMF and related settings.

Document Settings

This section contains document management settings specific to the study, as opposed to domain-wide settings which apply to all studies.

 

Auto-Name Documents

This is an on and off toggle, set to off by default, which enables auto-naming behavior for documents uploaded to the study. Once a user has enabled this setting, they may define the document auto-naming convention using both free text and the following tokens: 

• File Name
• Study Name
• Country Name
• Site Name
• Artifact
• Milestone
• Upload Date
• Modification Date
• Uploading User Name
• Uploader Email

Once auto-naming has been enabled for a study, newly uploaded documents will display their system generated name during the upload process. Redundantly named documents within a single artifact will be automatically enumerated to distinguish them from each other. 

 

Deleting a Study

Study Managers and eTMF Administrators may delete a study from the status drop-down at the top of the Study Configuration page. The Delete Study option only appears when all of the following conditions are met:

• The acting user has Study Manager or eTMF Administrator permission
• The study is in Inactive status
• The study contains no child countries

Selecting the Delete Study option launches a confirmation modal, where the user must enter their username and password and select a reason for deletion before confirming with the Delete button, or backing out with Cancel.

Studies may only be deleted if they contain no associated documents. If documents have been uploaded at the study filing level, the deletion will be prevented and an error will be displayed.

Upon successful deletion, the study's system-managed folders in Collaborate are also deleted, and the user is automatically navigated to the My Studies page. All study deletions are captured in the audit log, including the name of the deleted study, the acting user, and the reason provided.

Artifact Configuration

The Artifact Configuration tab is where a Study Manager or eTMF Administrator can indicate what documents are expected for a study. This informs what artifacts are available for selection during the document upload process, and how the system calculates completeness reports for studies. 

To learn more about configuring the expected artifacts for a study within Egnyte eTMF, read Artifact Configuration Based on the DIA Reference Model.

Permissions

This tab allows Study Managers and eTMF Administrators to define who has access to what within a given eTMF study. Learn about eTMF roles and permissions in this article.

Import

The Import tab allows a Study Manager or eTMF Administrator to ingest data for an existing study into Egnyte eTMF. Crucially, this process must be done first before other elements of the study are configured. Learn more about how to ingest an existing study into Egnyte eTMF on this page.

Study Filing Levels

The left-side menu displays the filing levels which have been configured for the Study. Navigate to a specific filing level by clicking on it in the filing level tree.

Deleting Filing Levels

Countries and sites can be deleted by an Administrator or Study Manager. This may be helpful for studies which are created from a template where a fraction of the copied study hierarchy does not apply to the new study. 

Filing levels may only be deleted if they contain no associated documents. If documents are present, users will be prevented from proceeding with deletion. 

All deletions are captured in the audit log, including the name of the deleted filing level, its parent study and country, the acting user, and the reason provided.

Editing a Site ID

Study Managers and eTMF Administrators may edit the Site ID for an existing site. The Site ID field, located on the Site Details tab of the Site Configuration page, is editable and behaves consistently with the Site Name and other editable fields on the page.

When a user enters a new Site ID value and clicks Save Changes, the new value is automatically reflected in the following places:

• The Study/Trial/Country/Site navigation tree in the study UI
• The Filing Level metadata value for all documents uploaded to that site
• The labels of the site's corresponding folders in Collaborate, including the folders for staging blinded, staging unblinded, non-staging blinded, and non-staging unblinded site documents.

All Site ID changes are captured in the audit log, including both the prior and new values.

Learn more about creating and configuring study filing levels on this page.