Using Expected Document Lists alongside your milestones enables milestone-based TMF planning and completeness reporting. It also supports detailed Study Startup milestones and improves your ability to share information across your TMF and Study Startup teams. You can apply EDL Templates to your milestones and set the value of your Milestone document fields by EDL Items. Additionally, you can use Override EDL Templates to further refine the expected documents at the Country level.
Note: This feature is only available on Clinical Operations Vaults.
Applying EDL Templates to Milestones
To measure TMF completeness at key points in time for a study, you can apply EDL templates to study milestones. In order to apply an EDL template to a milestone, the level of each must be the same (for example, country-level EDL templates to a study country milestone). Depending on the configuration of the EDL template you are applying, this action will add/remove EDL items and/or may update the attributes (such as number expected or requiredness) of existing EDL items. In addition to applying a template, you can also configure the EDL template as needed to increase/decrease document quantities and/or add/remove EDL items specific to the particular milestone.
You can apply EDL templates to both milestones created from templates and milestones created individually.
How to Enable Milestone-Based EDL Templates
To enable this feature, navigate to Admin > Settings > General Settings and click Edit. In the Expected Document List (EDLs) Options section, set the Enable Milestone based EDL template checkbox and click Save.
How to Apply EDL Templates to Milestones
To apply an EDL template to a milestone:
- Navigate to the milestone record.
- From the Actions menu, select Add Expected Documents.
- In the Apply Expected Document List, select a template to apply to the milestone. If no templates appear, click the binoculars icon to filter and select a template.
- Once you have selected a template, click Finish.
If you specified a Template EDL for the milestone template, when creating a milestone template, Vault creates your EDL from that template when you Create Milestones from Template.
Milestone-Specific Expected Documents
You can specify which types of milestones Vault creates when you apply an EDL Item Template to a milestone based on the configuration of the following fields on the EDL Item Template:
- Milestone Type: Vault will create and relate Expected Documents if the Milestone Type on the EDL Item Template matches the milestone’s type.
- Owning Milestone: Vault will only create Expected Documents for the types of milestones specified in the Owning Milestone field. When it does so, it will set the Owning Milestone field on the new Expected Document and will relate it to the Owning Milestone, as well additional milestones based on the Milestone Type field in the EDL Item Template. This allows you to track documents that are specific to individual milestones, such as protocol amendments and submissions.
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.
Relationship Between Milestones & EDL Items
When creating EDL Item records, Vault creates many-to-many relationships between the EDL items and the Milestone records. Vault creates one (1) Milestone Item record for each combination of EDL Item and Milestone.
EDL Hierarchical View
For each Milestone record, you can open EDL Hierarchical View. EDL Hierarchical View displays all of a Milestone record’s Expected Documents in a tree-like structure, grouped by document type, sub-type, and classification.
Setting Milestone Document Field Values by EDL Item
You can configure your Vault to fill the Milestone field on documents using your Expected Document List. Setting Milestone field values by EDL Item populates the Milestone field on documents based on the EDL Items the document matches.
How to Enable Set Milestone Values by EDL Item
To enable this feature, navigate to Admin > Settings > General Settings and click Edit. In the Expected Document List (EDLs) Options section, set the Manage Milestone field value by Expected Documents checkbox and click Save.
When this feature is enabled:
- Vault populates the Milestone field on the latest version of the document, ignoring Milestones with Actual Finish Dates.
- The Documents section of Milestone records displays only the latest versions of documents related to that particular Milestone record.
- The Milestone document field becomes read-only.
Override EDL Templates
You can create Override EDL Templates to capture differences in required documentation for each required country without recreating the standard EDL Template for each country. For example, you start with a standard EDL template, applying non-country-specific global standards. Then, create Override EDL Templates for country-specific modifications and additions. As a result, you end up with a final EDL that combines global standards (from your Standard EDL Template) with country-specific elements for each country (from your Override EDL Template for that Country) for which you have set up Override EDL Templates.
To create an Override EDL Template:
- Navigate to the EDL Template object, either through a custom tab or in Business Admin > Objects.
- Click Create.
- Fill in the required fields.
- Select the Override checkbox.
- Select the Parent EDL Template.
- Select the Template Country.
- Click Save.
Once you have set up the Override EDL Template, Vault applies it to templates that reference the selected Parent EDL Template and the selected Template Country. This gives you greater control over your EDLs at the Study Country level, without requiring you to have separate templates for each Study Country.
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.
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:
| Type | Permission Label | Controls |
| Security Profile | Settings: General Configuration: Edit | Ability to enable features in General Settings |
| Security Profile | Objects: Milestone: Edit | Ability to edit Milestone records |
| Security Profile | Objects: Milestone Item: View | Ability to view Milestone Item records |
| Security Profile | Objects: EDL Template: View | Ability to view EDL Template records |
| Security Profile | Objects: EDL Item Template: View | Ability to view EDL Item Template records |
| Security Profile | Objects: EDL: Create, Edit | Ability to create and edit EDL records |
| Security Profile | Objects: EDL Item | Ability to create and edit EDL Item |