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 configuration details for features that are only available in Clinical Operations Vaults.
Configuring Reference Sites
Reference Sites allow users to update Expected Documents across multiple sites without having to bulk update each individual Expected Document.
To enable Reference Sites in your Vault:
- Ensure that the desired users have the appropriate permissions to mark a Study Site record as a Reference Site.
- Configure a workflow on the site object and add a step with the System Action Update Related Expected Documents. When you do so, you must select a scope for the update:
- All sites in same study: the action will update EDL Items at all sites in the same study as the reference site.
- All sites in same study country: the action will update EDL Items at sites only in the same study country as the reference site.
- Add a user action on the site lifecycle to trigger the new workflow.
Managing EDL Bulk Update Options
Note: It is recommended to use Reference Sites 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.
To remove this option from the dialog, navigate to Admin > Settings > General Settings and select the Hide Update Related EDL Items in the Same Study for Bulk Updates checkbox. You can add this option back to the dialog by clearing this checkbox.
Configuring the Create Expected Documents Action
You can configure the Create Expected Documents action as an event action or entry action on the following lifecycles:
- Study Person Lifecycle
- Selected Study Organization Role Lifecycle
- Study Product Lifecycle
Configuring 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, 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.
Synchronizing Requiredness with # Expected
You can configure Vault to automatically update the # Expected field when the Requiredness field is updated. Without this option enabled, you will need to update # Expected manually. To enable:
- Navigate to Admin > Settings > General Settings > Expected Document List (EDL) Options.
- Check the box next to Synchronize Requirediness and # Expected.
When this setting is enabled:
- Setting Requiredness to Required will update # Expected to 1 if its current value is 0
- Setting Requiredness to Not Required will update # Expected to 0 if its current value is greater than 0
Updating Requiredness and # Expected Based on EDL Matching
Vault can automatically update the Required and # Expected fields based on the EDL Match Job. This is an additional feature that Vault support can enable on top of Synchronize Requirediness and # Expected. Without this option enabled, you will need to update any # Expected field values greater than 1 manually. You must raise a support ticket for this feature to be enabled.
When this setting is enabled:
- When the number of matched documents increases to more than zero, Vault updates the Required field value to Required if the previous value was anything other than Required.
- When the number of matched documents is greater than the value in the # Expected field, Vault updates the # Expected field with the number of matched documents. You may also use the bulk action Set # Expected to # Actual to update the # Expected field with the number of documents matched to the Expected Document if the # Expected field is less than the All Document Count field.
Note: Vault automatically increases the # Expected field as more documents are found by the EDL Match Job, but it does not reduce the # Expected field if documents unmatch. Users can still update the # Expected field manually.