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 expected documents, you can measure milestone completeness and monitor study startup progress by reporting on the status of the study’s expected documents, matched documents, and related Milestone records. You can also include Expected Document Lists in your milestone templates to more easily track your study’s expected documents. For more information, see Using EDL with Milestones.
Note: This feature is only available on Clinical Operations Vaults.
How to Configure Milestone Types
Before creating milestones and associating them with documents, you need to configure a set of milestone types that represent each kind of milestone you track. You can do this by adding picklist values for the standard Milestone Type document field.
Configuring Automated Calculation of Milestone Cycle Times (Study Startup)
Mapping the custom Milestone Types in your Vault to standard Global Milestone Types with Global Milestone Mapping records enables Study Startup Vaults to automatically calculate Cycle Time records when a milestone record is completed or modified.
About Global Milestone Types
Global Milestone Types are standard types defined and provided by Veeva. You cannot edit Global Milestone Types or create custom ones.
Navigate to Business Admin > Global Milestone Types to view the standard milestone types in Vault.
Mapping to Global Milestone Types
To map Milestone Types to Global Milestone Types:
- Navigate to Business Admin > Global Milestone Mappings > Create.
- Select the standard Global Milestone Type and Level combination. Note that Vault ensures that you select a level matching that of the selected Global Milestone Type.
- Select the Milestone Type that maps to the corresponding standard milestone type. Note that the level of the Milestone Type must match the level of the Global Milestone Type.
- Click Save.
You can map multiple Milestone Types to each Global Milestone Type.
You must approve a Global Milestone Mapping record and trigger the “Process Global Mapping” action before it can be used to calculate Cycle Times.
Configuring the Process Global Mapping Action
The Process Global Mapping entry action flags milestones for evaluation by the Calculate Milestone Cycle Time Records job. The action flags milestone records with Actual Finish Dates based on the lifecycle state of corresponding Global Milestone Mapping records.
To configure the Process Global Mapping action:
- Navigate to Admin > Configuration > Object Lifecycles > Global Milestone Mapping Lifecycle.
- Open the applicable lifecycle state. Note that the Global Milestone Mapping record must be in Complete State for Vault to calculate cycle time.
- Edit the Entry Actions section.
- Click Create Entry Action.
- Select Process Global Mapping.
- Click Save.
About Global Milestone Offsets
Vault compares the level and type of milestones with actual finish dates to the Global Milestone Offsets and calculates cycle times based on the intervals between the Actual Finish Dates of the milestones.
Note: Veeva defines and provides Global Milestone Offsets. You cannot edit Global Milestone Offsets or create custom ones.
Navigate to Business Admin > Global Milestone Offsets to view the standard offsets in Vault, the previous and next global milestone type of each offset, and the offset type of each record.
About the Calculate Milestone Cycle Time Records Job
The Calculate Milestone Cycle Time Records job evaluates the milestones in your Vault and, when applicable, calculates cycle times for each milestone. Milestones that include a value for Study Part (arm__v), will be excluded from the nightly Cycle Time job and will not skew cycle time metrics.
You must activate the Calculate Milestone Cycle Time Records job for Vault to calculate cycle times. You can schedule the job to run at any time of day. Otherwise, Vault defaults the job to run nightly at midnight UTC. Activate and schedule the job from Admin > Operations > Job Definitions > Calculate Milestone Cycle Time Records.
When the Calculate Milestone Cycle Time Records job is enabled, Vault flags milestones, evaluates them, and calculates cycle times that meet one or more of the following criteria:
- A new milestone record is created and has an Actual Finish Date.
- The Actual Finish Date is populated or edited on a milestone record.
- A change is made to one of the following fields on a milestone record with an Actual Finish Date:
- Milestone Type
- Study
- Study Country
- Site
- The level and milestone type match that of a Global Milestone Mapping record that was approved that day.
Note that Vault clears milestones flagged for evaluation each day. If the job is inactive, they do not remain flagged for evaluation when the job is reactivated.
When the job runs, it deletes all existing Cycle Time records for each flagged milestone. It also deletes Cycle Time records that do not have values for one or more of the following fields:
- End Date
- Previous Milestone
- Next Milestone
The Calculate Milestone Cycle Time Records job then evaluates flagged milestones and creates Cycle Time records if the following conditions are met:
- The milestone’s Level and Milestone Type are mapped to a Global Milestone Type.
- That Global Milestone Type has at least one (1) related Global Milestone Offset record.
- The other Global Milestone Type in that Global Milestone Offset record has a Global Milestone Mapping record.
- There is a milestone of the same level and type of that Global Milestone Mapping, and in the same Study, Study Country, and Site as the flagged milestone being evaluated.
Vault can recalculate all Cycle Time records in your Vault. Contact Veeva Support about scheduling the recalculation for all of the milestones in your Vault.
Milestone Templates
You can plan your milestones and study startup activities with fewer clicks by using milestone templates, expected document list (EDL) templates, and task templates. Setting up templates does not prevent users from creating milestones, EDLs, clinical user tasks, or milestone dependencies individually.
Creating milestones from a Template Milestone Set also creates any Expected Document Lists, Milestone Dependencies, and Clinical User Tasks included in the template. After creating a set of milestones, related records, and clinical user tasks from a template, users can create additional records manually. For example, Thomas could create the entire milestone set from a template and then add an extra Site Inspection milestone that wasn’t initially included.
How to Enable Milestone Templates
To enable, select the Enable Milestone Templates checkbox from Admin > Settings > Application Settings.
How to Set Up Milestone Templates
The Create Milestones from Template action uses a Template Milestone Master Set, Template Milestone Set, Template Milestones, Story Events, Milestone Dependency Template, and Template Task object records to create Milestones, Milestone Dependencies, Expected Document Lists, and Clinical User Tasks. Creating and editing the template records works like any other object record.
Note: To create and edit your templates more efficiently, you can configure the page layout for the Template Milestone Set object by adding related object sections for Template Milestone, Milestone Dependency Template, and Template Tasks. When you create the related records from the detail page for the Template Milestone Set record, Vault will automatically set their relationships.
To create a template set:
- Create Template Milestone Set records for each group of milestones that you want the template to create. This record should have a name that will make sense to users creating milestones from the template. These values will copy over to the milestones created using the template. To define the creation action for a Template Milestone Set, select a Story Event in the Story Event field.
- Create a Template Milestone record for each milestone that you want the template to create. Select a Template IRB / EC Type and Milestone Type for each template. You can choose to set up milestone autocompletion on a template by template basis. Connect each Template Milestone record to the Template Milestone Set you created first by selecting it from the Template Milestone Set field.
- Optional: Create a Template Task record for each Clinical User Task that you want the template to create. Associate these to a Template Milestone Set in the Template Milestone Set field, or create a Task Template from the object Details page of a Template Milestone Set. Tasks created from this template use the level of the corresponding Template Milestone Set: Study, Study Site, or Study Country.
- Optional: Create one Milestone Dependency Template record for each milestone dependency that you want the template to create. Select a Milestone Dependency Template Type (Finish to Finish, Rollup, etc.). The milestone dependencies created from this template will use the corresponding type. Select the Next Template Milestone and Previous Template Milestone to set up the dependency relationship. Connect the Milestone Dependency Template record to the list template you created first by selecting it from the Template Milestone Set field. This field may be auto-populated by the parent of the Previous Template Milestone record.
- Optional: In Clinical Operations Vaults, select a Template EDL to specify which template Vault applies to EDLs when you create milestones from template.
- Create a Template Milestone Master Set record. Select Study Initialization Set, a Study Country Initialization Set, and a Study Site Initialization Set for the template, which controls where users can create milestones using this template: at the study, country, or site level.
You can associate your Template Milestone Set records with the Template Milestone Master Set by creating Selected Milestone Set records.
- From the Template Milestone Master Set record, scroll to Selected Milestone Sets.
- Click Create.
- Select a Template Milestone Set to associate with the Template Milestone Master Set.
- Click Save.
After creating templates, users can easily create all the milestones for a study with the Create Milestones from Template action.
How to Set Up Milestone Autocompletion
To enable, select the Enable Milestone Autocompletion checkbox from Admin > Settings > Application Settings.
You can set up your Template Milestone or Milestone records so that Vault automatically populates the milestone Actual Finish Date and, if configured, moves the milestone to its Complete state when certain criteria are met.
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 Actual Finish Date value is cleared.
Optional: You can configure Vault to automatically move your milestones to their Complete lifecycle state during autocompletion. To do so, you need to define a complete state for your Milestone lifecycle.
- Navigate to the Milestone lifecycle.
- Click Edit.
- Select a Complete State.
- Click Save.
To configure autocompletion for individual Milestones or Template Milestones.
- Navigate to the Template Milestone or Milestone record.
- Click Edit.
- From the Autocomplete picklist, select All Dependencies or Any Dependency.
- Click Save.
Selecting All Dependencies means that Vault will autocomplete a milestone if:
- All required EDL Item records associated with the milestone have matched with documents in their steady state.
- All required clinical user tasks associated with the milestone are completed.
- All Previous Milestone records have an Actual Finish Date or are in their Completed lifecycle state.
Selecting Any Dependency means that Vault will autocomplete a milestone if:
- All required EDL Item records associated with the milestone have matched with documents in their steady state.
- All required clinical user tasks associated with the milestone are completed.
- At least one Previous Milestone record has an Actual Finish Date or is in its Complete lifecycle state.
Vault does not autocomplete milestones if there are no defined previous milestones or related EDL items. You must manually complete these milestones.
How to Set Up Automated Milestone State Changes
Vault can attempt to automatically move a Milestone to a new state after certain fields are updated, without the user having to perform additional lifecycle actions. The following automations are available:
- Move the Milestone to the Complete state when the Actual Finish Date is populated
- Move the Milestone to the Planned state when the Planned Finish Date is populated
- Move the Milestone to the Planned state when the Planned Start Date is populated and a value exists on the Expected Duration (Days) field
- Move the Milestone to the Started state when the Actual Start Date is populated
To enable this feature, navigate to Admin > Settings > Application Settings > Milestones and set the Automate Milestone State Changes checkbox. All available automations will be enabled.
Should any entry criteria prevent Vault from changing the state, the Milestone remains in its present state, and the date will not be saved. You will have to update the record so any entry criteria are satisfied before you can save the date and change the record’s state
How to Set Up Automated Enrollment Milestones (CTMS)
You can configure your CTMS Vault to automatically populate the Actual Finish Date fields of first and last subject-related milestones based on the corresponding dates entered for related Subject records at the site level. To do this, navigate to Admin > Settings > Application Settings and set the Enable Automated Enrollment Milestones checkbox.
How to Set Up Milestone Date Offsets
Your Milestone lifecycle includes a standard Update Dependencies object workflow. The Update Dependencies object workflow allows users to update all downstream milestones at once while updating a single Milestone record’s Baseline or Planned date. The workflow uses a system action, Update Dependent Milestone Dates, to propagate your changes.
Set the Block Automatic Updates field to No to prevent the Update Dependencies workflow from updating the date fields on a Milestone record.
You can include a Date Offset value (number of true days) in your Milestone Dependency Templates. When a user updates the Baseline or Planned date on a Milestone, Vault propagates that update to all downstream milestones, using the Date Offset in each dependency. For example, if a user updates the Baseline date on a milestone from 04/29/2017 to 05/02/2017, and the Milestone Dependency has a Date Offset value of 4, Vault updates the Baseline date on the dependency’s Next Milestone record to 05/06/2017, or 4 true days later.
Note: Vault will not create or update a dependency if doing so will cause a circular dependency.
Create Milestones at Events
You can configure Story Event records, which trigger Vault to create milestones, EDL items, and clinical user tasks at defined events, such as changing lifecycle states from Qualifying to Initiating. You can also use Story Events to represent ad hoc events, for example, a protocol amendment. Note that Story Events can only create milestones at their configured level (Study, Study Country, Study Site).
To create Story Events:
- Navigate to the Story Events object through Admin > Business Admin or a custom tab.
- Click Create.
- Fill the required fields.
- Select a Level.
- Select a Milestone Creation Trigger from the picklist. The Milestone Creation Trigger defines when the Story Event will create the associated Story Milestone.
You can relate Story Events to Template Milestone Sets by selecting a Story Event record from the Story Event object reference field on a Template Milestone Set record.
Story Events in Object Lifecycles
You can configure an entry or user action to create milestones, EDL items, and clinical user tasks for ad hoc events. By creating milestones this way, you tie study plan adjustments directly to your business processes. You can add the following configurations to your Study, Study Country, and Study Site object lifecycles.
If you want to configure your lifecycle to create milestones upon a user action, configure a user action:
Apply milestone template: This user action prompts the user to select their ad hoc Story Event from which to create milestones, clinical user tasks, and EDLs.
Note that if a user initiates this action from within a workflow, Vault assigns the Vault Owner group as Owner of the object records created. If you want Vault to assign the initiating user as Owner of the object records, use a state change.
To configure your Vault to create milestones at a certain state change, configure an entry action:
Apply milestone template: This entry action creates milestones, EDLs, and user tasks at lifecycle state change or initialization. You can select a Story Event record and a Milestone Creation Trigger for milestone creation.
Task Templates
You can configure Template Tasks to create standard, individual Clinical User Tasks as part of planned study activities in Clinical Vaults. You can also use Template Tasks to represent ad hoc events, for example, a power outage at a study site that triggered a temperature excursion.
Template Tasks are associated with a Template Milestone Set. When you create milestones from a Template Milestone Set, Vault creates individual Clinical User Tasks from the associated Template Tasks. If the Template Task is associated with a Template Milestone, Vault creates a relationship between the new Clinical User Tasks and the templated Milestone. Task types relate to the level of the corresponding Template Milestone Set: Study, Study Country, or Study Site.
To create Template Tasks:
- Navigate to the Template Tasks object through Admin > Business Admin, a related object, or a custom tab.
- Click Create.
- Enter a name for the Template Task. The Template Task should have a name that will make sense to users.
- Enter an Expected Turnaround Time. The instantiated task’s due date is determined by the current date plus the number of days in the expected turnaround time.
- Select a Category from the picklist.
- Select a Template Milestone Set and Template Milestone to relate to the Template Task. When a user creates a Clinical User Task from this template, Vault will automatically relate any tasks to the templated Milestone record. If you create and relate a Template Task from the Object Details page of a Template Milestone Set, Vault auto-populates this field with the parent Template Milestone Set.
- Select a Priority from the picklist.
- Select the Requiredness of a task for milestone completion.
- Click Save.
Note that Clinical User Task object records display as the appropriate level object type (Study Task, Study Country Task, or Study Site Task). When Vault creates a Clinical User Task from a Template Task, Vault uses the object type based on the Level of the corresponding Template Milestone Set (Study, Study Country, or Study Site).
Milestone Rollups
Milestone Rollups are a type of milestone dependency. When you use rollup-type milestone dependencies, the system will automatically calculate date values for the associated milestone unless the Block Automatic Updates field is set to No on the dependent record.
How to Enable Milestone Rollups
This feature is available by default for Study Startup Vaults. You can turn off milestone rollups by deselecting the Enable Milestone Rollups checkbox in Admin > Settings > Application Settings.
Note that Vault does not rollup the Actual Finish Date for milestones with autocomplete configured. Instead, milestone autocompletion populates the Actual Finish Date field.
Study Hierarchy & Rollup Dependencies
Note that Previous Milestone and Next Milestone for Rollup type Milestone Dependencies follow the Study, Study Country, and Study Site hierarchy.
- If the previous milestone is a study site-level milestone, the next milestone must be a study-country or study level milestone.
- If the previous milestone is a study country-level milestone, the next milestone must be a study-level milestone.
- If the previous milestone is a study-level milestone, you cannot create a rollup milestone dependency. Study level milestones are at the top of the hierarchy.
Rollup Enhancements
You can add more functionality to Milestone Rollups by selecting the Enable Milestone Rollup Enhancements checkbox in Admin > Settings > Application Settings. Once enabled, Vault applies new default behaviors to Milestone Rollups to ensure proper completion.
Milestone Gating
You can configure milestone gating to check if the milestone indicated in the Previous Milestone field on the Milestone Dependency record, expected documents, and associated clinical user tasks are complete before a user can mark the milestone as Completed. For example, users can’t complete the Patient Enrollment milestone before completing the Site Preparation milestone. You can use milestone gating to enforce the order in which your sites should complete milestones. You can also use milestone gating to ensure that users have reviewed and updated expected documents before proceeding.
To use milestone gating, you must configure entry criteria on the Milestone object’s Completed lifecycle state to require that previous milestones have Actual Finish Dates, that all related expected document records have matched with steady-state documents, and that all related clinical user tasks are complete. Note that each of these criteria must be configured separately. You can also configure these requirements as a decision step in the Milestone object workflow.
Entry Criteria for Milestone Object Lifecycles
If you choose to manage your Milestone object with a lifecycle, you can use the following entry criteria to gate entry into particular states:
- Milestone documents are completed checks that all expected document records associated with a milestone have matched with documents.
- Previous milestones have actual dates checks that all previous milestones (associated by Finish to Finish type Milestone Dependency records) have values for the Actual Date field.
- Milestone tasks are completed checks that all required tasks associated with a milestone are complete.
- EDL Items are not Pending Decision checks that all related EDL items have a Requiredness value of Required or Not Required.
Decision Steps for Milestone Object Workflows
When implementing milestone gating, you may also choose to allow overrides on some or all of your milestone dependencies. To support that configuration, there are additional decision rules for object workflows:
- Milestone documents are completed checks that all expected document records associated with a milestone have matched with documents.
- Previous milestones have actual dates checks that all previous milestones (associated by Finish to Finish type Milestone Dependency records) have values for the Actual Date field.
- Milestone tasks are completed checks that all required tasks associated with a milestone are complete.
- EDL Items are not Pending Decision checks that all related EDL items have a Requiredness value of Required or Not Required.
Entry Action to Copy Field to Related Object
With the Copy Field to Related Object entry action, you can copy the value of a field to a field on a related object. This entry action can help you manage your milestone completeness across multiple object records. For example, you could configure an entry action to copy the Forecast Finish Date from a Milestone record to the Forecast SIV Date on your Study Site record when a user action moves the Milestone record to Planned.
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 | Controls |
|---|---|---|
| Security Profile | Objects: Template Milestone Master Set | Ability to create and edit Template Milestone Master Set records |
| Security Profile | Objects: Template Milestone Set | Ability to create and edit Template Milestone Set records |
| Security Profile | Objects: Template Milestone | Ability to create and edit Template Milestone records |
| Security Profile | Objects: Milestone Dependency Template | Ability to create and edit Milestone Dependency Template records |
| Security Profile | Objects: Template Task | Ability to create and edit Template Task records |
| Security Profile | Objects: Story Event | Ability to create and edit Story Event records |
| Security Profile | Objects: Selected Milestone Set | Ability to create and edit Selected Milestone Set records |
| Security Profile | Objects: EDL Template | Ability to create and edit EDL Template records; necessary for applying EDL templates to template milestones |
| Security Profile | Objects: EDL Item Template | Ability to create and edit EDL Item Template records; necessary for applying EDL templates to template milestones |
| Security Profile | Objects: Milestone | Ability to create and edit Milestone records; necessary for working with templates. You must have create and edit permission on all object types for the Milestone Dependency object. |
| Security Profile | Objects: Global Milestone Mapping | Ability to create, edit, and delete Global Milestone Mapping records; necessary for mapping Global Milestone Types for cycle time calculation |
| Security Profile | Objects: Global Milestone Offset | Ability to read Global Milestone Offset records; necessary for mapping Global Milestone Types for cycle time calculation |
| Security Profile | Objects: Global Milestone Type | Ability to read Global Milestone Type records; necessary for mapping Global Milestone Types for cycle time calculation |
| Security Profile | Objects: Cycle Time | Ability to read Cycle Time records |
| Security Profile | Objects: Milestone Dependency | Ability to create and edit Milestone Dependency records; necessary for working with templates. You must have create and edit permission on all object types for the Milestone Dependency object. |
| Security Profile | Objects: Milestone Item | Ability to create and edit Milestone Items records; necessary for working with templates |
| Security Profile | Objects: Clinical User Task | Ability to create and edit Clinical User Task records; necessary for working with templates |
| Security Profile | Objects: EDL | Ability to create and edit EDL records; necessary for working with milestone templates including EDLs |
| Security Profile | Objects: EDL Item | Ability to create and edit EDL Item records; necessary for working with milestone templates including EDLs |
| Security Profile | Admin: Application: Edit | Ability to enable features in Application Settings |
| Security Profile | Configuration: Object Lifecycles: Edit | Ability to edit object lifecycles; necessary for configuring milestone gating |
| Security Profile | Configuration: Picklist: Edit | Ability to edit picklists; necessary for configuring Milestone Types |