**Source URL:** https://clinical.veevavault.help/en/lr/31833/index.md # 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](/en/lr/32749/). This article provides details for features that are only available in Clinical Operations Vaults. To learn about EDL options, see [Configuring EDLs](/en/lr/63271/). 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][3] based on the configuration of _EDL Item Templates_.
## 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][3] and link them to open milestones * [Milestone-based EDL templates](/en/lr/37991/) * 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][6] (harvey balls) for _EDL Items_ * [Hovercards][7] 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_
## Clinical-Specific EDL Field Explanations {#etmf_edl_fields} | 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_. |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][6] 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 {#bulk-update} 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. 1. Navigate to the _Study_ record. 2. Edit the study and select an **EDL Template**. 3. Click **Save**. 4. 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.
Vault can also create EDLs as part of the [Create Milestone from Template](/en/lr/24430/#about_milestones_from_templates) action, or via a [lifecycle state change](/en/lr/24430/#milestones_story_events). ### 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 {#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](/en/lr/63271/#configuring-reference-sites), 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
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. 1. Find the site- or country-level _EDL Item_ record and make any necessary edits to the _Requiredness_ or _# Expected_ fields. Save your changes. 2. From the record's **Actions** menu, select **Update Related EDL Items**. An options dialog will open. 3. If you're updating site-level records, choose a scope for the update. This option may not be available in some Vaults. 4. Use the checkboxes to indicate the fields you wish to update. 5. 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. ### Related Permissions 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](/en/lr/33725/) 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](/en/lr/33725/). ## How Vault Creates Person-, Organization-, and Product-Specific Items {#product-specific} 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_](/en/lr/33316/#edl_template_setup). 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.
## How to Drag & Drop Upload Files from EDL Items You can create documents by uploading single source files from an _EDL Item_: 1. Navigate to the _EDL Item_ record. 2. 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. 3. 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. 4. Click **Save**. Vault uploads the document and automatically matches it to the _EDL Item_. You can also [upload multiple files](/en/lr/3486/) 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](/en/lr/21893/). ## How to View Related EDL Items 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 {#milestone-relationship} In eTMF and Study Startup Vaults, you can create many-to-many relationships between EDL items and [document milestones](/en/lr/37991/). 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](/en/lr/33827/). ### 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**](/en/lr/31833/#configuring_milestone_items_with_edls). 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](/en/lr/30683/#how_to_define_state_entry_or_user_actions) 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 {#status_indicators} _Expected Document_ records display a status indicator icon (or "harvey ball"), representing the item's [_Completeness_](/en/lr/32749/#completeness) value. |Icon|Status| |--- |--- | |Not Started Icon|Not Started| |In Progress Icon|In Progress| |Completed Icon|Complete|
## Expected Document Hovercard {#hover_cards} 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 ## Related Permissions 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](/en/lr/22824/): |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](/en/lr/61279/#) 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.| [3]: #product-specific [6]: #status_indicators [7]: #hover_cards [11]: #edl-version-support