Working with Expected Document Lists (EDLs)

In Clinical Operations Vaults, Expected Document Lists (EDLs) help you plan your TMF and more accurately report on TMF completeness. An EDL defines a checklist of the trial records expected (and those specifically not expected) for a specific study, study country, study person, study organization, study product, or site.

EDLs are available on all Vaults. To learn about platform EDL features, see Working with EDLs. This article provides details for features that are only available in Clinical Operations Vaults. To learn about EDL options, see Configuring EDLs.

You can create EDLs in bulk or individually for a single study, its study countries, and its sites. Once you’ve created an EDL for a specific study, study country, or site, you can update the EDL to match that study’s specific requirements and attributes. You can also tailor a site-/country-level EDL item and cascade the changes to all sites/countries in the study, or all sites within the same study country.

Adding a Study Person, Study Organization, or Study Product to a study triggers Vault to create EDL Items linked to open milestones based on the configuration of EDL Item Templates.

Note: Depending on your Vault’s configuration, the EDL Item object may appear as ‘EDL Item,’ ‘Expected Document,’ or a customized label.

Clinical-Specific EDL Features

The following features and configuration elements are only available in Clinical Operations Vaults:

Requiredness field on EDL Items
Template sets (defined by selecting a parent template) for creating a hierarchy of study-, study country-, and site-level templates
Bulk creation of EDLs using templates
Action to update related country- and site-level EDL Items
Action to view related EDL Items for the same document type and level
Action to create EDL Items specific to a study’s personnel, organizations, and products and link them to open milestones
Milestone-based EDL templates
Setting to auto-populate the Milestone document field, based on EDL Items, on the latest version of matched documents
Drag & drop to upload files on EDL Items
Status indicators (harvey balls) for EDL Items
Hovercards for EDL Items
Ability to trigger the EDL automation creation job from the Study Person, Study Product, and Selected Study Organization Role objects in bulk on a single record
Action to enable or disable Auto-Manage # Expected

Note: Manual matching is not available for Clinical Operations Vaults.

Clinical-Specific EDL Field Explanations

Field Name	Explanation	Objects
Template Country	Allows you to indicate the related country for a study country-level EDL template.	EDL
Parent	Allows you to select another EDL record as the parent of the current record; by selecting parent EDL templates (a country-level template for a site-level template, a study-level template for a country-level template), you create a template set that replicates the structure of the Study object hierarchy.	EDL
Department	Allows visibility into document status by department, so you can address issues with specific departments.	EDL Item
Requiredness	Allows you to indicate if the EDL Item is required, not required, or optional. In some Vaults, optional may appear as Pending Decision. - Required: This document is expected and required. - Not Required: This document is neither expected nor required. - Optional / Pending Decision: A decision needs to be made to determine whether or not this document is required and expected for this study.	EDL Item
Level	Allows you to indicate which level of the study hierarchy an EDL Item applies to, i.e., does it represent study-level documents, country-level documents, or site-level documents. On EDL Items, this is a lookup-type field that references the value for the parent EDL record.	EDL, EDL Item
Study	Study that the EDL or EDL Item represents. On EDL Item, this is a lookup-type field that references the value for the parent EDL record.	EDL, EDL Item
Study Country	Study Country that the EDL or EDL Item represents. On EDL Item, this is a lookup-type field that references the value for the parent EDL record.	EDL, EDL Item
Study Site	Study Site that the EDL or EDL Item represents. On EDL Item, this is a lookup-type field that references the value for the parent EDL record.	EDL, EDL Item
Object Type	Object type of the EDL Item, EDL Template, or EDL Item Template record.	EDL Item, EDL Template, EDL Item Template
Selected Study Organization Role	Selected Study Organization Role that the EDL Item represents.	EDL Item
Study Organization	Study Organization that the EDL Item represents.	EDL Item
Study Person	Study Person that the EDL Item represents.	EDL Item
Study Product	Study Product that the EDL Item represents.	EDL Item
Study Organization Role	Allows you to indicate what study organization roles should use this EDL Item Template when creating expected documents.	EDL Item Template
Study Team Role	Allows you to indicate what study team roles should use this EDL Item Template when creating expected documents.	EDL Item Template
Study Product Role	Allows you to indicate what study product roles should use this EDL Item Template when creating expected documents.	EDL Item Template
Template Behavior	Allows you to indicate whether your template reuses or updates existing field values on EDL Items when creating EDL Items from a template. - Reuse does not modify the existing (duplicate) Expected Document. This behavior also occurs when the field is left blank. - When the # Expected field is in scope, Update increases the # Expected by the value from the Template Expected Document - When the Requiredness field is in scope, Update changes the Requiredness field value to match the Requiredness field from the Template Expected Documents - Create generates a new EDL Item if the previous EDL Item record is Complete. Create is only applicable if the EDL Versioning is enabled for EDL Items.	EDL Item Template
Template Update Scope	Allows you to indicate whether your template updates or does not update the Expected Document Count and Requiredness fields based on existing EDL Items and their matched documents. Select one or both fields to update field values. This field is only available when Milestone-based EDL Templates are enabled.	EDL Item Template
Completeness Status	Provides a visual representation of the EDL Item record’s Completeness value, driven by the EDL matching job.	EDL Item
Milestone Type	Allows you to indicate what milestone types should use this EDL Item Template when creating expected documents.	EDL Item Template
Owning Milestone	Allows you to indicate the milestone this EDL Item.	EDL Item
Owning Milestone Type	Allows you to indicate what types of Milestones for which EDL Items should be specifically created based on this EDL Item Template. EDL items are created and related from template only for the milestone types specified here.	EDL Item Template
Expected Document Version #	Provides clarity on what document version is needed per milestone.	EDL Item
Auto-assign Version Number	Allows Vault to automatically assign a value to the Expected Document Version # field when creating the EDL Item record.	EDL Item Template
Auto-Manage # Expected	Allows you to indicate whether Vault should automatically keep the # Expected field in sync with the All Document Count field.	EDL Item Template, EDL Item

Bulk Creating EDLs

Once EDL templates are set up, you can bulk create EDL Item records for a study. This action creates EDLs for study countries and sites that do not have active EDLs, as well as the study-level EDL Item records.

Navigate to the Study record.
Edit the study and select an EDL Template.
Click Save.
From the study’s Actions menu, select Create Expected Document Lists.

Vault will automatically create the EDL and EDL Item records. This process may take several minutes, depending on how busy your Vault is.

Note: The Create Expected Document Lists action is not visible in Vaults with the EDL Template Refactor enabled. The Hide Pre-EDL Refactor Actions setting under Application Settings > Expected Documents List (EDL) option controls access to this action.

Vault can also create EDLs as part of the Create Milestone from Template action, or via a lifecycle state change.

Applying Updated EDL Templates

Users may update Template EDLs due to changes in business operations or regulatory guidance. To apply the latest Template EDL to in progress studies, from the Studies list view use the ellipses to perform a bulk action and use the Apply Template EDL Update (Bulk) record . This action creates missing EDLs, Expected Documents, and Milestone Items for all active, incomplete Milestones.

Re-Trigger Expected Documents

If desired, you can use the Re-Trigger Expected Documents action from the Study Person, Study Product, or Selected Study Organization Role objects. When you run this action, Vault starts the EDL Automation Creation job.

Reference Sites

To help manage Expected Documents across multiple Sites, you can designate one site per study country as a Reference Site. To do this:

Navigate to the Site record.
Edit the site and check the box for Reference Site.
Click Save.

If a Reference Site is already set for that Study Country, Vault displays an error message. Deactivate an existing Reference Site before setting a new one.

Reference Sites provide the following behavior:

Updating Existing Expected Documents Based on the Reference Site

After adding Expected Documents to a Site designated as a Reference Site, any updates to those Expected Documents can be reflected on all other Sites, in the same country or study, that have matching or related expected documents. For example, if the EDL template includes items for Other Approvals and Data Privacy Agreement that both have a Requiredness of Pending Decision, but the Reference Site has both as Required, you wish to make those items Required at other sites where the expected documents already exist.

This is done by starting a workflow that has the Update Related Expected Documents workflow action configured. Depending on Admin configuration, this action updates EDL Items at all Sites in the same Study Country, or all Sites in the same Study.

EDL Items on the Reference Site are considered matching or related if they meet the following criteria:

They are site-level and in the same Study Country
They are of the base object type and not matching on Owning Milestone
They are matching on the same matching fields, and are of the same document type.

The following fields will be updated based on the reference site’s values:

Requiredness
# Expected
Any custom fields that are of data type picklist and which exist on both the EDL Item and EDL Item Template objects.

Updating New Expected Documents Based on the Reference Site

When creating Expected Documents from Template on a new study site, Vault checks to see if that country has a Reference Site for the Study. If it does, any EDL Item records that match those on the Reference Site are altered to reflect any differences. For example, if the EDL template includes an Other Approvals document with a Requiredness of Pending Decision, but the Reference Site has it as Required, the document will be Required at the new site.

Bulk Updating Site- & Country-Level Items

Note: If your Vault is configured to use Reference Sites, use that feature instead of bulk updating.

After modifying the Requiredness or # Expected fields on an EDL Item for one site or for one country, you can bulk update these fields for all sites/countries in the same study or for all sites in the same study country.

Find the site- or country-level EDL Item record and make any necessary edits to the Requiredness or # Expected fields. Save your changes.
From the record’s Actions menu, select Update Related EDL Items. An options dialog will open.
If you’re updating site-level records, choose a scope for the update. This option may not be available in some Vaults.
Use the checkboxes to indicate the fields you wish to update.
Click Continue. This action may take several minutes to complete, depending on how busy your Vault is.

Admins can remove the Update Related EDL Item user actions from any lifecycle states as desired.

If the EDL Item object uses Dynamic Access Control, you may not have edit access on all records. When you use the bulk update action, Vault skips any records that you cannot edit. You won’t receive any warnings about the records you don’t have access to. Vault simply lists the records it updated.

Details & Limits

The following limitations apply to the Update Related EDL Items action:

This action only updates the # Expected and Requiredness fields for the EDL Item records.
This action can only update site-level EDL Item records within a single study. If you need to make changes across multiple studies, for example, because your EDL template was incorrect, we recommend that you use bulk object record editing to make those changes.
This action can only update a single item at a time. For example, you can update the “Data Privacy Agreement” item across all sites, but to update multiple items across sites, you must use the Update Related EDL Items action on each individually. If you need to change a large number of EDL items, you must do one of the following:
- Use the Reference Sites feature by triggering a workflow with the Update Related Expected Documents action configured.
- Use the Update Related EDL Items action on each individually.
- Use bulk object record editing.

How Vault Creates Person-, Organization-, and Product-Specific Items

When you add a Study Person, Study Organization, or Study Product to a study in a specific role, Vault identifies EDL Item Templates with matching values in the Study Team Role, Selected Study Organization Role, or Study Product Role fields and creates expected documents for those records. Vault links the documents to open milestones based on the value of the Milestone Type field in the EDL Item Template.

Your Admin can configure Vault to create EDLs upon record creation or when the records enter a specific lifecycle state with the Create Expected Documents action. You can also use the Re-Trigger Expected Documents action from the Study Person, Study Product, or Selected Study Organization Role objects to start the EDL Automation Creation job. You can execute the action on individual records as well as in bulk.

The EDL Automation Creation job does not create expected documents when the associated Study, Study Country, or Study Site is in an Excluded lifecycle state.

Note: This feature is only available if the EDL Template Refactor feature is enabled in your Vault. To enable, navigate to Admin > Settings > Expected Document List (EDL) Options and check EDL Template Refactor in your Clinical Operations Vault. Learn more about EDL Template Refactor.

How to Drag & Drop Upload Files from EDL Items

You can create documents by uploading single source files from an EDL Item:

Navigate to the EDL Item record.
Drag and drop your file onto the EDL Item record. You can only upload one document at a time. Note that this is only available for new documents. You cannot use drag and drop upload to create a new version.
Vault populates the document type based on the EDL Item and auto-fills certain fields based on the EDL Item values. Fill any remaining required fields in the Upload File dialog.
Click Save. Vault uploads the document and automatically matches it to the EDL Item.

You can also upload multiple files using the Upload action on the EDL Item.

Limitations to Drag & Drop Upload Files from EDL Items

Vault only matches the document to the EDL Item when the Batch Update field value is Yes.
Vault does not check files for duplicate content detection.

The View Related action on an EDL Item record shows all EDL Item records for the same document type within the same study, study country, or site. This action lets you quickly find related items without having to manually apply filters.

Site-level EDL Item records: Choose to view all related site-level EDL items or only those within the same study country
Country-level EDL Item records: Displays all related country-level EDL items for the same study
Study-level EDL Item records: Displays all related study-level EDL items for the same study

To see this action, your Vault must include a custom tab showing records for the EDL Item object and you must have access to view that tab.

Milestone Relationship

In eTMF and Study Startup Vaults, you can create many-to-many relationships between EDL items and document milestones. When configured, Vault auto-populates the Milestone document field on the latest version of matched documents with the value from the EDL Item record’s Milestones field. These relationships tell Vault which items to show in the Site Activation Progress view.

Milestone Items with EDLs

Milestone Item records connect an EDL Item to a Milestone. Users can set a Milestone Item record to Inactive when an EDL Item will not be used for a Milestone. Setting a Milestone Item to Inactive indicates that this version of the EDL Item is not applicable for this Milestone. To allow users to set Milestone Items to Inactive, Admins must configure the Milestone Item Lifecycle.

To allow users to set Milestone Items to Inactive, navigate to Admin > Configuration > Objects > Milestone Item. Click Edit and select the Milestone Item Lifecycle from the Lifecycle drop-down. You must then add a user action on the lifecycle’s Active state to Change State to Inactive.

Removing Milestone EDL Items

Vault tracks the manual removal of Expected Documents from Milestones When users manually remove EDL Items from a Milestone (via Milestone Item deletion), Vault does not recreate the deleted Milestone Item when the system re-evaluates the Expected Document with the release of another Milestone record on the particular Study. Users must manually add back the removed Expected Documents back to a Milestone record, if the previously removed Expected Document is needed.

Status Indicators

Expected Document records display a status indicator icon (or “harvey ball”), representing the item’s Completeness value.

Icon	Status
	Not Started
	In Progress
	Complete

Note: When making changes to Expected Documents, you may have to refesh the page to see the changes reflected in the Completeness status indicators.

Expected Document Hovercard

When you hover over an Expected Document, Vault displays a hovercard for the record. This hovercard includes:

Status indicator icon
Completeness value
Percentage complete (Steady State Document Count divided by # Expected)
List of matched documents with the document’s Name, Status, and Version
# Expected value

You can complete all steps in this article with the standard Business Admin, System Admin or Vault Owner profile.

If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission Label	Controls
Security Profile	Objects: EDL Item: Read	Ability to access the Match Documents action on an EDL Item record.
Security Profile	Objects: EDL: Create, Edit	Ability to create and edit EDL records.
Security Profile	Objects: EDL Item: Create	Ability to create EDL Item records.
Security Profile	Objects: EDL Item: Edit	Ability to edit EDL Item records. Ability to upload documents to EDL Item records; if Sharing Settings are enabled on EDL Item, you must also have the Editor role.
Security Profile	Objects: EDL Template: Create, Edit	Ability to create and edit EDL Template records; Read permission needed to create EDLs from a Study.
Security Profile	Objects: EDL Item Template: Create, Edit	Ability to create and edit EDL Item Template records; Read permission needed to create EDLs from a Study.
Security Profile	Application: EDL Matching: Edit Match Fields	Ability to create and edit EDL records and to edit the EDL Matching Field value on an EDL record.