Working with EDLs

Expected Document Lists (EDLs) help you to measure the completeness of projects like clinical studies using the EDL and EDL Item objects. Individual records in the EDL object represent a list of expected documents. EDL Item is a child object of EDL; individual EDL Item records represent a specific type of document. Metadata fields on the EDL Item records indicate how many documents you need to collect (Expected Steady State Count).

EDL includes functionality to match documents to individual EDL items based on the Matching EDL Item Fields setting for the parent EDL record. The batch matching job is an automatic recurring action through the Job Scheduler that compares documents in the Vault to EDL Item records and then updates both the Completeness value and document counts for each EDL item.

EDL Item to Document Matching

Vault matches documents to EDL Item records based on the Matching EDL Item Fields setting for the parent EDL record. When matching on a multi-value document field, only one of the values must match the EDL Item record. EDL Item to Document matching may exclude and unmatch inactive document types depending on how it was configured in your Vault. Contact Support to enable this feature.

For example, on the “Blitz Campaign” EDL record, the matching fields are set to: Document Type > Subtype > Classification, Country, Product, and Campaign. “Television Ad” is an EDL Item record that belongs to this EDL. When the matching job looks for documents, it will consider a document as a match if the document’s Classification, Country, Product, and Campaign values are the same as those on the EDL Item record.

There are several types of document-to-EDL Item matching in Vault: continuous, on-demand, manual, and batch matching. On-demand and manual matching are available to you from the EDL Item record’s Details page. Continuous matching evaluates documents and EDL Items for matches after you perform actions on either. Vault can also automatically match documents in a regular job, which an Admin can configure in your Vault.

The batch matching job updates the All Document Count, Steady State Document Count, and Completeness fields when matched documents are archived. Continuous, on-demand, or manual matching won’t update these fields for archived matched documents. The batch matching job will not execute successfully if there are duplicate document type labels, even if they are inactive.

How to Create EDLs

For EDL records, fill in:

• Name
• Matching EDL Item Fields (limited to 16 fields)
• Batch Update (set to Yes)

For EDL Item records, fill in:

• Name
• EDL (parent)
• Expected Steady State Count
• All fields defined for matching in the parent EDL record

Once you’ve created the records, Vault will update the calculated fields (Completeness and document counts) the next time the batch matching job runs. If you have access, you can also manually trigger matching on individual EDL Item records.

How to Create EDLs from Templates

If your Vault has EDL Template records, you can create EDLs and EDL items from templates.

1. Navigate to the EDL object, either through Business Admin > Objects or a custom tab. In Clinical Operations Vaults, this action is available in the Study, Study Country, and Study Site objects when configured. In RIM Submissions, this action is available through Submission records.
2. From the Actions menu, click Create EDL from Template.
3. Select an EDL Template.
4. Click Continue.

Vault creates EDL and EDL Items based on the template you selected. Vault first attempts to make an exact match. If there is no exact match, Vault selects the default. Vault populates the Source EDL Template field with the selected template.

Continuous Matching

After any of the following events, Vault automatically evaluates documents and EDL Items for new or updated matches:

• Upload a new document
• Update a matching field value on a document
• Document enters or leaves its lifecycle’s Steady state
• Update a matching field value on an EDL Item record
• Update a matching lookup field on an EDL record

Vault displays a banner notification on the current page when matching documents.

Starting in 19R3, the continuous matching process updates the calculated fields on new EDL Item records (Completeness and document counts) for all matched documents that are not locked to a Steady state, even if the Batch Update field is set to No or left blank. This enables Vault to more accurately track an EDL Item’s completeness.

Vault will not update tracking fields on existing records where Batch Update is set to No or left blank unless you update the EDL Item record or the matched document, triggering continuous matching. To update all existing existing records, contact Veeva Support.

On-Demand Matching

Sometimes, you need to immediately find matching documents and update counts and completeness for a specific EDL item. To do this, use the Match Documents option from the EDL Item record’s Actions menu.

This action works the same as the batch matching job, but only affects a single EDL item. The action is only available if the EDL Item record is active and Batch Update is set to Yes.

Manual Matching

Manual EDL Item to document matching enables you to manually match and unmatch documents, lock an EDL Item match to a specific document version, and exclude automatically matched documents from completeness counts.

Contact Veeva Support to enable this feature.

How to Manually Match & Unmatch Documents

To manually match or unmatch a document from an EDL Item:

1. Navigate to the EDL Item record, either through Business Admin > Objects or a custom tab.
2. Scroll to Matched Documents.
3. Click Add.
4. Click the green plus (+) icon to match a document with the EDL Item record.
5. Click the red minus (-) icon to unmatch a document from the EDL Item record.
6. Click Save.

Manually matched documents can also be unmatched by clicking Remove Document in the Matched Documents section.

How to Lock a Matched Document Version

To lock an EDL Item match to a specific document version:

1. Navigate to the EDL Item record, either through Business Admin > Objects or a custom tab.
2. Scroll to Matched Documents.
3. Click the grid Actions menu for the matched document you want to lock.
4. Select Lock Version.
5. Select a document version from the drop-down.
6. Click OK.

After you lock a matched document to a specific version, the automatic matching job will not update or replace it, even if there are more recent versions or if a document enters a Superseded lifecycle state. Vault will only remove or replace the locked version if the matching fields on the locked document version no longer match those on the EDL Item.

You can unlock a matched document by selecting Unlock Version from the grid Actions menu.

How to Exclude Matched Documents

To exclude an automatically matched document from completeness calculations on your EDL Item record:

1. Navigate to the EDL Item record, either through Business Admin > Objects or a custom tab.
2. Scroll to Matched Documents.
3. Click the grid Actions menu for the matched document you’d like to exclude.
4. Click Exclude Document.
5. Click Continue in the confirmation dialog.

To include an automatically matched document after excluding it, select Include from the matched document’s grid Actions menu in the EDL Item record. Vault will update the completeness counts and set the document’s Include In Total field to Yes.

Once you exclude a document, Vault performs the following actions:

• Vault excludes the document from All Document Count and updates the document’s Include In Total field to No. If the document is in its Steady state, Vault excludes the document from Steady State Document Count.
• If excluding the document changes the difference between the Expected Steady State Count and Steady State Document Count fields, Vault updates the Completeness value.
• Vault sets the Iterations without Updates field of the grandparent EDL record to zero (0).

You can only exclude automatically matched documents. To unmatch manually matched documents, click Remove Document in the Matched Documents section.

Automatic Matched Document Version Locking

Vault can automatically lock a matched document version to an EDL Item once the document reaches Steady state. Once locked, continuous or batch matching jobs no longer update that document version on the EDL Item.

If a document version has not yet locked, you can still manually lock a matched document version or exclude a matched document.

How to Automatically Lock Matched Document Versions

To set up automatic document version locking, navigate to your EDL or EDL Template record and set the Lock Matched Documents on Steady State field to Yes. Ensure that Batch Update is set to Yes on EDL Items you want to automatically lock.

The Lock Matched Documents on Steady State field is automatically available on the EDL and EDL Template objects in all Vaults with EDLs enabled and custom matching fields configured. This feature also enables Manual Matching. Contact Veeva Support to enable this feature in other Vaults.

You’ll need to assign the Lock Matched Documents on Steady State field to any applicable object types. You must add the Lock Matched Documents on Steady State field to the EDL or EDL Template object page layouts manually in existing Vaults.

Locking Matched Document Versions in Other Lifecycle States

By default, you can only lock documents in the Steady and Superseded states, but you can configure other lockable states as well. End users can then manually lock any matched document versions in these states. However, automatic version locking is only available for the Steady state.

How to Create Documents from EDL Items

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

1. Navigate to the EDL Item record detail page or a list page showing the record.
2. From the record Actions menu, choose Upload.
3. Vault selects a document type based on the EDL item and auto-fills certain fields based on the EDL Item values.
4. Proceed with the standard document creation process.

The next batch matching job will match the newly created document to the EDL Item record.

Creating Placeholders from EDL Items

You can also create placeholder documents from EDL Items. You can create placeholders from individual records or as a bulk action.

Creating Documents from Templates for EDL Items

Documents can also be created from templates for EDL Items by selecting Create Document from Template from the record Actions menu.

The Create Document from Template action is only available if one of these two conditions exist:

• The Document Type field on the EDL Item contains a document type that has controlled document templates.
• The Document Type field on the EDL Item is not populated, and the user has permission to create at least one document type that has controlled document templates.

Defaulting Document Fields

When you create a placeholder or upload a document from an EDL Item record, Vault defaults similar document fields to match those on the EDL Item record, for example, the Study field.

Vault defaults field values for the following field types:

• Text
• Number
• Date
• DateTime
• Yes/No
• Picklist (single & multi-value)
• Object Reference

EDL & EDL Item Field Explanations

When creating, editing, or reviewing EDLs and EDL Items, you can refer to these field explanations.

Field Name	Explanation	Objects
Matching EDL Item Fields	Defines the fields that Vault will compare to match individual EDL Item records to documents; see details.	EDL
Batch Update	Controls whether the standard batch matching job will look for matches based on this record Vault automatically sets this to "No" once the matching job has run a certain number of times without detecting any change. By default, this number (called Maximum EDL Iterations) is 10. If you need to change this, contact Veeva Support.	EDL
Last Matched Time	(Non-editable) Indicates the last time the batch matching job found a match for EDL Items in this EDL	EDL
Iterations without Updates	(Non-editable) Indicates the number of times the batch matching job has looked for matches and found no new documents or updates to matched documents for EDL Items in this EDL	EDL
EDL	Parent EDL record	EDL Item
Steady State Document Count	(Non-editable) Indicates the number of matching documents in their lifecycle's Steady state (including Superseded), according to the last batch matching job and any manual match changes	EDL Item
All Document Count	(Non-editable) Indicates the total number of matching documents, according to the last batch matching job and any manual match changes	EDL Item
Expected Steady State Count	Allows you to indicate the number of documents that you expect to collect for this EDL Item	EDL Item
Completeness	(Non-editable) Indicates whether document collection for this EDL Item is complete; see details.	EDL Item
Locked Document Count	Indicates the number of locked documents for an EDL Item.	EDL Item

Completeness

The Completeness field provides three statuses:

Status	Conditions
Not Started	EDL Item: Expected Steady State Count is one (1) or greater Documents: No matching documents located in any lifecycle state
In Progress	EDL Item: Expected Steady State Count is one (1) or greater Documents: Matching documents found, but fewer are in their lifecycle Steady state than the expected number
Complete	EDL Item: Expected Steady State Count is one (1) or greater Documents: Matching documents found and at least the expected number are in their lifecycle Steady state OR EDL Item: Expected Steady State Count is zero (0)

Related Permissions

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

An Admin may configure Atomic Security to allow or prevent you from performing certain actions in specific lifecycle states.

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

Type	Permission Label	Controls
Security Profile	Objects: EDL Item: View	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, including object actions; necessary for working with templates.
Security Profile	Objects: EDL Item: Create	Ability to create EDL Item records; necessary for working with templates.
Security Profile	Objects: EDL Item: Edit	Ability to edit EDL Item records; necessary for working with templates. 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	Application: EDL Matching: Run	Ability to access the Match Documents action on an EDL Item record.
Security Profile	Application: EDL Matching: Edit Match Fields	Ability to edit the EDL Matching Field value on an EDL record.
Security Profile	EDL Matching: Edit Document Matches	Ability to lock the document version matched with an EDL Item record, exclude or include matched documents in summary fields, and manually match or unmatch documents from an EDL Item.