Expected Document Lists (EDLs) help your organization to measure the completeness of projects like clinical studies. The feature achieves this using the EDL and EDL Item objects, as well as automatic and manual processes that match documents to individual EDL Item records and populate document count and completeness fields. Learn more in Working with EDLs.
Note: Depending on your Vault’s configuration, an EDL Item may appear as EDL Item, Expected Document, or a customized label. In RIM Submissions, you’ll relabel EDLs as Content Plans.
To set up EDL, you need to complete the following processes:
- Enable EDLs
- Set up custom matching fields
- Activate the matching job
- Set up EDL templates
- Configure an EDL Item with Matched Documents report type (optional)
How to Enable EDLs
Select the Enable Expected Documents Lists (EDL) option in Admin > Settings > General Settings to turn on this feature. Vault automatically creates the document matching job. EDL Item to Document matching can also exclude and unmatch inactive document types. Contact Support to enable this feature.
Automatic matching links documents to EDL Item records based on matching field values. There are two types of automatic document matching: continuous and batch. Both types of matching rely on matching fields.
Matching fields are criteria that Vault uses to match individual documents to an EDL Item record. Often, you’ll need to set up custom matching fields. These can be text-, picklist-, or object-type fields.
To set up a new matching field:
- From Admin > Configuration > Document Fields, verify that the document field exists. If you plan to match on document type, also verify that the field applies to the specific document type. Make a note of the document field name, for example, product__v.
- From Admin > Configuration > Objects > EDL Item > Fields, verify that an analogous field exists. Verify that the field name matches that of the document field, excluding the suffix, for example, product__c. If an analogous field doesn’t exist, create a new field on the object. Picklist fields on EDL Item cannot be multi-value. The EDL Item Field Label cannot exceed 40 characters.
- From Admin > Business Admin > Picklists > EDL Matching Field, add a new picklist value. The value name must match that of the document and object fields, for example, product__c. Note that you may only add 20 fields to this picklist.
The continuous matching feature matches EDL Items to documents whenever you make a change to documents or EDL Item records. This feature is automatically enabled when you enable EDLs and activate batch matching. For details about using continuous matching, see Learn more in Working with EDLs.
Note that continuous matching is disabled for documents you create or update in Document Migration Mode.
Note: In Clinical Operations vaults, the Batch Update field defaults to Yes on all EDLs. Set this field to No to exclude an EDL from continuous matching.
Vault creates the Match EDL Items to Documents definition within the job scheduler when you enable EDL on your Vault, but this job is inactive by default. To activate it, navigate to Admin > Operations > Job Definitions. Edit the job definition and set the Status field to Active.
Batch matching evaluates all EDL Items with the Status field set to Active.
If needed, you can change the scheduling, job owner, or document conditions. Note that you cannot create new jobs with the Match EDL Items job type. If your Vault uses a document state like Not Needed, rather than deleting unneeded documents, you may want to add a condition that excludes documents in that status, so that Vault doesn’t include them in EDL Item matching document counts. Learn more about job scheduling.
How to Manually Trigger Batch Matching Jobs
Vault runs the matching job daily. If needed, you can trigger the job to start immediately.
- Open Admin > Operations > Job Status.
- Find the job definition. In the Actions menu, choose Start Now.
Manual EDL Item to document matching enables users to manually match and unmatch documents, lock the EDL Item match to a specific document version, and exclude specific matched documents from completeness counts. See Learn more in Working with EDLs.
Contact Veeva Support to enable this feature. Manual matching is not available for Clinical Operations Vaults.
You can lock a matched document version to an EDL Item. By default, you can only lock documents in the Steady and Superseded lifecycle states, but you can configure other document lifecycle states to be lockable as well. All locked documents in any such lifecycle states are tracked for each EDL Item in the Locked Document Count field.
To enable locking documents in additional lifecycle states, you must:
- Populate document lifecycle states in the Lockable Document States field.
- Configure the new field in the EDL Item object page layout.
How to Enable Matched Document Version Locking
- Navigate to Admin > Settings > General Settings and locate the Expected Document List (EDL) Options section.
- In the Lockable Document States field, select up to ten (10) active document lifecycle states.
- Configure the object page layout to display the Locked Document Count field. Vault maintains this field as matched documents are locked, unlocked, and unmatched. Admins in RIM Submissions Vaults can also configure the Progress Icon formula field to reference Locked Document Count.
Once you have completed these steps, end users can view and lock matched document versions in any of the lifecycle states you have selected.
Templating for EDL uses the EDL Template and EDL Item Template objects. Vault uses these templates when users initiate the Create EDL from Template action.
Prior to V16, templating used a field (Is Template) on the EDL object. These objects replace that functionality.
Depending on your Vault’s configuration, additional template options may be available. See Working with EDLs in Clinical Operations for details.
How to Create EDL Templates
- Navigate to the EDL Template object, either through a custom tab or in Business Admin.
- Click Create.
- Fill the required fields, as well as any additional fields required for your template.
- Click Save.
After creating your EDL template, you can create and associate EDL Item Templates with it.
- Navigate to the EDL Item Template object, either through a custom tab or in Business Admin.
- Click Create.
- Fill the required fields, as well as all fields required for matching in the EDL Template.
- Optional: In Clinical Operations Vaults, select a Milestone Type. Vault will create Expected Documents for milestones of the type you select here when you Create Milestones from Templates.
- Optional: In Clinical Operations vaults, select an Owning Milestone Type. Vault will create Expected Documents only for the types of milestones you select here when you Create Milestones from Templates.
- Click Save.
We recommend not using object types for EDL Templates and EDL Item Templates, as it can cause the Match EDL Items job to fail. If you decide to enable object types on EDL Templates and EDL Item Templates, we recommend that you contact your Vault representative first.
If you don’t have the following fields configured for every object type, the Match EDL Items job will fail and you may be unable to create EDLs from templates.
Clinical Operations vaults include additional fields on these objects. See Working with EDLs in Clinical Operations for more details.
Fields on EDL Template & EDL
- Last Matched Time
- Iterations without Updates
- Copied From
- Source EDL Template
- Parent (if enabled)
Fields on EDL Item Template & EDL Item
- All Document Count
- Steady State Document Count
- Source EDL Template
- Source EDL Item Template
You can configure report types in your Vault to report on EDL Items and their matched documents. You can use an EDL Item with Matched Documents report type to see which documents matched to which EDL Item record without navigating to each individual EDL Item record. To configure this report type, use EDL Item as the Primary Reporting Object, and report on both the Matched Documents object and Documents.
Vault automatically creates Matched Documents records during EDL Item to document matching. This complex join object represents the relationship between the EDL Item and the matched document.
The Matched Documents object only has reportable fields when manual matching is enabled. You can report on the following Matched Document fields:
- Version is Locked
- Include in Total
- Created By
- Created Date
- Modified By
- Modified Date
Vault includes the most recent document version in the report. If the version is locked via manual matching, Vault shows that specific version.
You can complete all steps in this article with the standard System Admin or Vault Owner profile.
If your vault uses custom security profiles, your profile must grant the following permissions:
|Security Profile||Objects: EDL||Ability to create and edit EDL records; necessary for working with templates|
|Security Profile||Objects: EDL Item||Ability to create and edit EDL Item records; necessary for working with templates|
|Security Profile||Objects: EDL Template||
Ability to create and edit EDL Item Template records
View permission needed to create EDLs from a study or submission (eTMF and RIM Submissions only)
|Security Profile||Objects: EDL Item Template||
Ability to create and edit EDL Template records
View permission needed to create EDLs items from a study or submission (eTMF and RIM Submissions only)
|Security Profile||Admin: General Configuration: Edit||Ability to enable features in General Settings|
|Security Profile||Admin: Jobs: Edit||Ability to edit the batch matching job definition|
|Security Profile||Application: EDL Matching: Run||Ability to access the “start” action on scheduled batch matching job|
|Security Profile||Application: EDL Matching: Edit Match Fields||Ability to edit the EDL Matching Field value on an EDL record; necessary to define custom matching fields on a template|
|Security Profile||Application: EDL Matching: Edit Documents 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|
|Security Profile||Admin: Objects: Edit||Ability to edit the EDL Item object configuration; necessary to edit field definitions for custom matching fields|
|Security Profile||Admin: Picklists: Edit||Ability to edit picklists; necessary to edit picklist for custom matching fields|
|Security Profile||Admin: Report Types: Create||Ability to create and edit new report types; necessary to create an EDL Item to Matched Documents report type.|
Learn more about permission sets.