Vault Milestones specify important points in time at the study, study country, and study site levels. During the course of a study, you accumulate documents of various types. By associating milestones with documents, you can measure milestone completeness by reporting on the status of the study’s documents and those documents’ milestones.
Note: This feature is only available on Clinical Operations Vaults.
How to Create Milestones
Milestone object records define your individual milestones. You can modify these in the same way as other object data records.
Even if you created milestones from a template, you can still add individual milestones.
Each milestone object record includes the Study, Study Country, or Study Site to which the milestone applies. The object record also specifies the planned and actual start and finish dates, the milestone type, and other milestones that share dependencies.
When creating or editing Milestone object records, you’ll need to fill the following object fields:
|Milestone||Name of the milestone: “Study Startup,” “Site Startup,” “Study Close,” etc. These will generally be visible to most users and, in the case of manual document-milestone linking, these users may be responsible for selecting the correct option.|
|Milestone Type||A classification for the milestone. An Admin defines these values in a picklist. (Study Startup only) Admins also use milestone types to determine what EDL items appear in the Site Activation Progress view.|
|Study||The Study to which the milestone applies; this field is always required.|
|Study Country||The Study Country to which the milestone applies; if you populate this field, the milestone will exist at the Study Country level To select this, you must first select a parent study from the Study field.|
|Study Site||The Study Site to which the milestone applies; if you populate this field, the milestone will exist at the Study Site level. To select this, you must first select a parent study country from the Study Country field.|
|External ID||Optional identifier for the milestone that is used by a non-Vault system.|
|Status||Status of the milestone object record: Active or Inactive. When Inactive, the milestone cannot be selected on documents or for relationships with other milestones.|
Note: Depending on your Vault’s version, application, and configuration, you may have different field labels on Milestone and its related objects.
In CTMS, Monitoring Event records have a Milestone object reference field. You can select a Milestone from this field to associate that milestone to the monitoring event. If you don’t select a Milestone, Vault creates a Milestone record of the correct type automatically after you save your Monitoring Event record. Depending on the object type of your Monitoring Event record, Vault creates different types of Milestones. For example, if you create a Pre Study Visit monitoring event, Vault creates a Pre Study Monitoring Visit milestone. Keep in mind that Vault only creates Milestones for the following standard monitoring event types: Interim Monitoring Event, Pre Study Visit, Site Close Out Visit, and Site initiation Visit.
Vault auto-populates the Study, Study Country, and Study Site fields on the new Milestone record. If your Vault has additional required fields on the Milestone object, the Milestone record creation fails. Vault sends you a notification for the failure. Note that Vault still creates the Monitoring Event record even if the Milestone record creation fails.
You can create Milestones in bulk using milestone templates. Template Milestones, Milestone Dependency Templates, and Template Tasks are grouped in a single Template Milestone Set object record, similar to ELDs. Once an Admin creates a Template Milestone Set, you can use it to create milestones in bulk at any level. You can create milestones from a template at the start of your study using the Create Milestone from Template action. When your study is in progress, and you require additional milestones to represent ad hoc events, such as a protocol amendment, your Vault may have Story Events configured to create milestones.
- Select Create Milestones from Template from the Study, Study Country, or Study Site’s Actions menu. The Create Milestones from Template dialog opens.
- Click Continue.
Vault creates Milestones from the template at the Study level and adds the associated Milestones to the Study Country and Study Site levels. After Vault creates Milestones, it checks to see if the associated Study has an EDL Template record associated with it. If it does, Vault will use that EDL Template when creating EDL Item records.
If the milestone template has its own EDL Template associated to it, Vault ignores it and uses the EDL Template at the Study level.
After the asynchronous job completes, you’ll receive a notification.
Depending on your Vault’s configuration, you can create milestones and EDLs for ad hoc events in your study using Story Events. Story Events represent different points in time during your Study, such as Site Selection or Protocol Amendment. They include templated milestones, milestone dependencies, and EDL items.
- Select Apply Milestone Template from the Study, Study Country, or Study Site’s Actions menu.
- Select a Story Event to use for milestone and EDL creation.
- Click OK.
- Vault creates milestones and EDLs from templates related to the Story Event at the Study level, and adds the associated milestones and EDLs to the Study Country and Study Site levels.
- After the asynchronous job completes, you’ll receive a notification.
You can use the Apply Milestone Template action during any lifecycle states it is configured for. This way, you can create any necessary milestones or EDL items for ad hoc events, as well as planned events.
Note that your Vault may have the Apply Milestone Template entry action configured in addition to or instead of the user action. With this configuration, Vault automatically creates the appropriate records when a Study, Study Country, or Study Site enters a certain lifecycle state.
Milestones & Task Templates
Depending on your Vault’s configuration, Admins can define the creation of templated Clinical User Tasks associated with a Template Milestone Set.
When you create milestones from a Template Milestone Set, either as part of planned activities or an ad hoc event, Vault creates individual Clinical User Tasks from the associated Template Tasks, sets their due dates, category, requiredness, and task priority, and populates the Study, Study Country, and Study Site based on the context in which they were created. Vault relates the Clinical User Task to the appropriate Milestone, based on the Template Milestone selected on the Template Task record. Vault creates Clinical User Tasks as Study Tasks, Study Country Tasks, or Study Site Tasks, based on the level of the Template Milestone Set. Vault sends a notification about task creation, and the newly-created user tasks appear in the task assignee’s My Tasks tab. You can complete and work with these tasks as you would for any user task.
Note that your Vault may have the Apply Milestone Template entry action configured in addition to or instead of a user action. With this configuration, Vault automatically creates the appropriate Clinical User Task records when an associated Study, Study Country, or Study Site enters a certain lifecycle state.
An Admin can configure your milestones to autocomplete. When the Autocomplete field is set to All Dependencies or Any Dependencies, Vault moves the milestone to the Completed lifecycle state and populates the Actual Finish Date field once dependent milestones are complete, EDL items have matched, and required Clinical User Tasks are complete. Vault uses the most recent date on previous milestones, matched documents, and required tasks for the milestone’s Actual Finish Date.
Vault does not recalculate % Complete, or any of the metric fields on which it is based, on completed milestones.
Note: Vault automatically calculates completeness metrics and autocompletion after a five-minute delay to ensure that the calculations account for related activities.
Admins can also set up milestone autocompletion on your existing Milestone object records.
An Admin can configure your CTMS Vault to automatically populate the Actual Finish Dates of first and last subject-related milestones based on the corresponding dates on Subject records at the site level and for a study arm or the study as a whole. For example, if the earliest Screened Date of the Subjects at a site is 10/27/2020, Vault automatically populates the Actual Finish Date of the First Subject Screened milestone for the site with 10/27/2020.
To utilize this feature, you must set the Metric Calculation field to Date-Based on the Study record. If the Metric Calculation field is set to Status Snapshot, Vault will not automatically populate the Actual Finish Dates of milestones for the study.
Note that subject-related milestones without study arms evaluate all subjects at the site, including subjects with study arms.
First Subject Milestones
The Actual Finish Dates of first-subject related milestones are populated as follows:
|Milestone Type||Auto-Populated Value|
|First Subject Consented||The earliest Initial Consent Date of the Subject|
|First Subject Screened||The earliest Screened Date of the Subject|
|First Subject In||The earliest Enrolled Date of the Subject|
|First Subject Randomized||The earliest Randomized Date of the Subject|
|First Subject Started Treatment||The earliest Started Treatment Date of the Subject|
|First Subject Treated||The earliest End of Treatment Date of the Subject|
|First Subject Started Follow Up||The earliest Started Follow Up Date of the Subject|
|First Subject Out||The earliest End of Study Date of the Subject|
Last Subject Milestones
The Actual Finish Date fields on last subject-related milestones are populated when you set the No New Subjects checkbox for the Study Site record and all subjects at the site meet the milestone criteria. Clearing the No New Subjects checkbox on the Study Site record clears dates from all related Milestone records.
The Actual Finish Dates of last-subject related milestones are populated as follows:
Last Subject Consented
The latest Initial Consent Date of the Subject
Last Subject Screened
The latest Screened Date of the Subject
Last Subject In
The latest Enrolled Date of the Subject
Last Subject Randomized
The latest Randomized Date of the Subject
Last Subject Started Treatment
The latest Started Treatment Date Date of the Subject
Last Subject Treated
The latest End of Treatment date of the Subject if all Subjects for the Study Site have either:
Last Subject Started Follow Up
The latest Started Follow Up Date of the Subject
Last Subject Out
The latest End of Study Date for the Subject if all Subjects for the Study Site have either:
No Subjects Enrolled
The No Subjects Enrolled field identifies any non-enrolling sites when you set the No New Subjects checkbox for the Study Site record. In your configuration, you can use this field to set a site’s milestones and determine which milestones dependencies to inactivate. This ensures proper roll-up of milestone dates. Clearing the No New Subjects checkbox on the Study Site record clears dates from all related Milestone records and sets No Subjects Enrolled to False/No.
How to Add Milestones to Documents
In order to use milestones, an Admin must first add the Milestone object document field to documents. When the Milestone document field is active and a Milestone object record exists, a user with Edit Document permission can update the field by choosing from existing milestones. An Admin can also configure a Vault to populate the Milestone field by EDL Item.
Viewing Expected Documents
You can view all Expected Document records associated with a Milestone record using EDL Hierarchical View.
The Milestone Type picklist field (
milestone_type__v) is defined on the Milestone object (
milestone__v) and as a document field. Vault allows an Admin to define custom milestone types based on the level of detail needed when tracking study startup or TMF completeness. Vaults using Study Startup and the associated milestone template set have milestones types pre-configured.
Your organization may expand milestone types to include higher levels of detail. This is common in large organizations who want to leverage milestone data coming from a CTMS or other project management source.
If you use Study Startup, your Admin can map standard milestone types and offset types to custom milestone types to enable Vault to automatically calculate cycle times for completed milestones.
Note: Note that your Admin must configure Global Milestone Mapping for Vault to calculate cycle times.
Vaults with Study Startup automatically calculate cycle times when an Admin has mapped Global Milestone Types to custom Milestone Types. Vault uses a system-managed job to calculate cycle times based on the actual offset times between milestones in your Vault. When active, the job calculates Cycle Times for milestones that meet one of the following conditions:
- A new milestone record was created and has an Actual Finish Date
- The Actual Finish Date field was populated or was modified since the job ran the day prior
- One of the following fields was modified since the job ran the day prior:
- Milestone Type
- Study Country
The job applies existing Cycle Time records to milestones, creates new records if needed, and deletes records that no longer apply.
How Vault populates new Cycle Time records for Finish to Finish offset types:
Number of days between the Actual Finish Dates of the next and previous milestones
If the difference is <= 0, the record is deleted
Actual Finish Date of the Previous Milestone
Actual Finish Date of the Next Milestone
Object Type of the corresponding Global Milestone Offset record
Study of the corresponding values in the Next Milestone record
Study Country of the corresponding values in the Next Milestone record
Site of the corresponding values in the Next Milestone record
Based on the configuration of the Global Milestone Offset record
Based on the configuration of the Global Milestone Offset record
About Milestone Object Types
If you use Study Startup, you may have default object types on the Milestone object. Milestone object types specify different fields and page layouts to differentiate types of milestones, like those related to submissions or study startup. You can select a Milestone object type when creating a new milestone record or by editing the Milestone Object Type field.
Each Milestone Dependency object record represents pre-conditions for a Milestone’s status. You can configure the order of milestones and the dependencies involved in milestone completion. When related to Milestone Dependency records, Milestone records can have many-to-many relationships. For example, one milestone may depend on the completion of three other milestones. Milestone dependencies follow the Study, Study Country, and Study Site hierarchy.
As of V16, milestone dependencies replaced “Up” and “Previous” milestone fields. (“Up” and “Previous” fields are still available.)
Example: Protocol Approval & Study Greenlight
For example, for a study to enter the Protocol Approval milestone, the milestone Study Greenlight must be in Completed status. This can be ensured using a “Finish to Finish” milestone dependency. An Admin can enforce the order of milestones by using a lifecycle and entry criteria.
Example: Site Initiation
For example, a “rollup” type dependency can automatically fill the Actual Finish Date field on the Country First Site Initiated milestone with the earliest Actual Finish Date from all of the Site Initiated milestones associated with that Study Country. In this example, the Country First Site Initiated milestone has multiple Milestone Dependencies. These “rollup” type dependencies all use Country First Site Initiated as the Next Milestone field, and each Site Initiated milestone is the Previous Milestone for each dependency.
A milestone dependency’s type determines how it functions:
|Finish to Finish||A user can’t set a milestone’s status as Done until the dependent milestone is Done. When the Date Offset (
Enabling Milestone Rollups introduces behavior for two (2) other milestone dependency types. You can also enable Milestone Rollup Enhancements, which adds additional checks and can provide more accurate rollup behavior in some scenarios.
Note: Your Vault may have customizations that modify the Standard Behavior listed here.
|Milestone Dependency Type||Standard Behavior (Milestone Rollups enabled)||Enhanced Behavior (Milestone Rollup Enhancements enabled)|
|Rollup (Max date)||Vault will not populate a milestone’s baseline, planned, and actual date fields until the milestones indicated in the dependency have relevant date values. Vault updates the field values to the latest possible date when the previous milestones are updated. If you set the Block Automatic Updates field to Yes, the baseline and planned dates will not be updated based on previous milestones. Vault will only update the actual date fields based on previous milestones.||Vault checks to see if any previous milestones have a null date value. If so, the next milestone retains the null value; otherwise, the next milestone uses the latest date. Both the milestone and the dependency must be active. Vault will not populate a milestone’s baseline, planned, and actual date fields until all of the previous milestone dates have values. Once all previous milestone dates are populated (or milestones or dependencies are inactivated), then Vault populates the milestone’s date with the latest possible date, which is the accurate last date.|
|Rollup (Min date)||Vault will not populate a milestone’s baseline, planned, and actual date fields until the milestones indicated in the dependency have relevant date values. Vault updates the field values to the earliest possible date when the previous milestones are updated. If you set the Block Automatic Updates field to Yes, the baseline and planned dates will not be updated based on previous milestones. Vault will only update the actual date fields based on previous milestones.||Vault gives the next milestone the earliest date value, or null if no earliest date exists. Both the milestone and the dependency must be active.|
If needed, an Admin can configure additional milestone dependency types.
Note: When a milestone dependency involves updating any date values, the audit logs record it as a System Action. The action is not dependent on the permissions of the user changing the date values on the previous milestone.
How to Create a Milestone Dependency
You can create milestone dependencies individually or from milestone templates using the Create Milestones from Template action. If you created milestones individually, you must also configure milestone dependencies individually:
- Open the Milestone Dependency object in Admin > Business Admin or in a custom tab.
- Click Create.
- Fill the required fields and relate the Milestone Dependency record to the correct Milestone records.
- For Finish to Finish type dependencies, enter a number of days in the Date Offset field. This number of days (true days) represents the number of days Vault adds to dependent milestones with the Apply Updated Dependencies workflow step.
- Click Save.
You can update Baseline and Planned dates of your milestone records, and then choose to have Vault propagate those changes to all downstream milestone records. Note that this is only available for milestones connected by Finish to Finish type milestone dependencies.
- Update a Milestone record’s Baseline or Planned date.
- Select the Apply updates to dependent milestones verdict to update dependent milestones.
- Vault initiates the Apply Updated Dependencies system action to update your dependent milestones based on the Date Offset field. Vault also reevaluates all existing rollups affected by the date changes.
- Vault sends a notification after updating all dependent milestones.
Choosing Dismiss closes the workflow task window and does not update any dependent milestones. Vault still saves your update to the Milestone record.
Set the Block Automatic Updates field to Yes to prevent the Update Dependencies workflow from updating the baseline and planned date fields on the next Milestone record. This setting supports top-down planning for the study.
Note: Vault cannot initiate the Update Dependencies workflow when a Milestone record is involved with a different object workflow. Wait until the active workflow ends before updating dependent milestones.
When you hover over a Milestone, Vault displays a hovercard for the record that allows you to quickly view a summary of the Milestone’s completeness. This hovercard includes:
- Milestone name
- % Complete; see details below for how Vault calculates this value
- Status indicator icon, representing the milestone’s Completeness value
- List of Milestone Dependencies with each record’s Completeness, Name, Planned Finish Date, and Actual Finish Date
- List of expected documents with the number of Expected, Actual, and Approved documents related to the Milestone
- List of matched documents with each document’s Name, Status, and Version
- Counts of clinical user tasks, with the number of Total, Complete, Required, and Complete Required clinical user tasks
Click a document or object record link in the hovercard to navigate to that document or record detail page. If you click a View All link, Vault navigates you to a list view, for example, a list of all Milestone Dependencies.
Note that Milestone hovercards must be enabled by an Admin.
Vault calculates the % Complete for a milestone by adding Completed Previous Milestones (
completed_previous_milestones__v), Completed EDL Item Records (
completed_edl_item_records__v) and Total Complete Required Tasks (
count_of_complete_required_tasks__v), and dividing that total by the sum of Total Previous Milestones (
total_previous_milestones__v), Total EDL Item Records (
total_edl_item_records__v), and Total Required Tasks (
Vault takes these values from EDL Item object records. Note that the # Expected value of the EDL Item record is not considered when calculating completeness.
In the Completeness field, Vault references a milestone’s % Complete and displays the value as a status indicator icon. If a milestone has an Actual Finish Date, the % Complete displays 100%, even if your Vault allows a milestone to complete before all expected documents are approved.
Vault does not recalculate % Complete, or any of the metric fields on which it is based, on completed milestones. It will only recalculate those fields if the value in Actual Finish Date is removed.
Note: Vault automatically calculates completeness metrics and autocompletion after a five-minute delay to ensure that the calculations account for related activities.
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:
|Security Profile||Objects: Template Milestone Master Set||Ability to view Template Milestone Master Set records; necessary to create milestones from template|
|Security Profile||Objects: Template Milestone Set||Ability to view Template Milestone Set records; necessary to create milestones from template|
|Security Profile||Objects: Template Milestone||Ability to view Template Milestone records; necessary to create milestones from template|
|Security Profile||Objects: Template Task||Ability to view Template Task records; necessary to create milestones from template|
|Security Profile||Objects: Milestone Dependency Template||Ability to view Milestone Dependency Template records; necessary to create milestones from template|
|Security Profile||Objects: Selected Milestone Set||Ability to view Selected Milestone Set records; necessary to create milestones from template|
|Security Profile||Objects: Story Event||Ability to view Story Event records; necessary to create milestones from a Story Event|
|Security Profile||Objects: EDL Template||Ability to view EDL Template records; necessary for creating milestones from templates including EDLs|
|Security Profile||Objects: EDL Item Template||Ability to view EDL Item Template records; necessary for creating milestones from templates including EDLs|
|Security Profile||Objects: Milestone||
Ability to create and edit Milestone records
|Security Profile||Objects: Cycle Time||
Ability to read Cycle Time records
|Security Profile||Objects: Milestone Dependency||
Ability to create and edit Milestone Dependency records
|Security Profile||Objects: Milestone Item||Ability to create and edit Milestone Item records|
|Security Profile||Objects: Clinical User Task||Ability to create and edit Clinical User Task records|
|Security Profile||Objects: EDL||Ability to create and edit EDL records; necessary for creating milestones from templates including EDLs|
|Security Profile||Objects: EDL Item||Ability to create and edit EDL Item records; necessary for creating milestones from templates including EDLs|