# Configuring Milestones 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](/en/lr/37991/). ## How to Configure Milestone Types {#configuring-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](/en/lr/1269/) for the standard *Milestone Type* document field. ## Configuring Automated Calculation of Milestone Cycle Times (Study Startup) {#configuring-automated-calculation-of-milestone-cycle-times} 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 {#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 {#mapping-to-global-milestone-types} To map _Milestone Types_ to _Global Milestone Types_: 1. Navigate to **Business Admin > Global Milestone Mappings > Create**. 2. 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. 3. 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_. 4. 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][3] before it can be used to calculate _Cycle Times_. ### Configuring the Process Global Mapping Action {#configuring-the-process-global-mapping-action} The *Process Global Mapping* [entry action](/en/lr/59885/#entry-actions) 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: 1. Navigate to **Admin > Configuration > Object Lifecycles > Global Milestone Mapping Lifecycle**. 2. Open the applicable lifecycle state. Note that the _Global Milestone Mapping_ record must be in Complete State for Vault to calculate cycle time. 3. **Edit** the _Entry Actions_ section. 4. Click **Create Entry Action**. 5. Select **Process Global Mapping**. 6. Click **Save**. ### About Global Milestone Offsets {#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.
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 {#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][5] _Global Milestone Type._ * That _Global Milestone Type_ has at least one (1) related [_Global Milestone Offset_][6] 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. ### Manually Recalculating Milestone Completeness To ensure that a Milestone's Completeness values are current, you can manually run the _Recalculate Completion Metrics_ from the **All Actions** menu of the _Milestone_ record. This action checks all Completeness metrics and updates them accordingly. ## Milestone Templates {#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 {#setting_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.
To create a template set: 1. 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*][7] in the **Story Event** field. 2. 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][8] 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. 3. Optional: Create a [_Template Task_][9] 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_. 4. 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](/en/lr/24430/#milestone-dependency-types).). 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. 5. Optional: In Clinical Operations Vaults, select a **Template EDL** to specify which template Vault applies to EDLs when you [create milestones from template](/en/lr/24430/#how-to-create-milestones-from-templates). 6. 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. 1. From the _Template Milestone Master Set_ record, scroll to **Selected Milestone Sets**. 2. Click **Create**. 3. Select a _Template Milestone Set_ to associate with the _Template Milestone Master Set_. 4. Click **Save**. After creating templates, users can easily create all the milestones for a study with the [**Create Milestones from Template action**](/en/lr/24430/#about-milestones-from-templates). ## How to Set Up Milestone Autocompletion {#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. 1. Navigate to the _Milestone_ lifecycle. 2. Click **Edit**. 3. Select a **Complete State**. 4. Click **Save**. To configure autocompletion for individual _Milestones_ or _Template Milestones_. 1. Navigate to the _Template Milestone_ or _Milestone_ record. 2. Click **Edit**. 3. From the **Autocomplete** picklist, select _All Dependencies_ or _Any Dependency_. 4. 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 Approval Milestone Autocompletion {#approval-milestone-autocompletion} Vault tracks Submissions by utilizing Submission _Application_ and _Approval_ milestone types. The Autocomplete Approval Milestone feature streamlines the Submission approval process by allowing Vault to automatically complete _Approval_ milestones based on the _Actual Finish Date_ and _Submission Decision_ fields on the _Application_ milestone. When you approve a Submission, Vault copies the _Application_ milestone _Actual Finish Date_ value to the _Approval_ milestones. You must use the following standard milestone types when using this feature: _Health Authority Application_ (`ha_application__v`), _Health Authority Approval_ (`ha_approval__v`), _EC/IRB Submission_ (`ec_irb_submission__v`), and _EC/IRB Approval_ (`ec_irb_approval__v`). You must also use the standard _Submission Decision_ picklist values. To enable the feature, navigate to **Admin > Settings > Application Settings** and select the **Enable Approval Milestone Autocompletion** checkbox in the _Milestone_ section.
### Health Authority Submissions Vault automatically completes the _Health Authority Approval_ milestone once the _Health Authority Application_ milestone meets all the following criteria:  * The _Actual Finish Date_ field contains a date. * The _Submission Decision_ field value is either _Approved_ or _Approved with Conditions_. The country-level _Health Authority Submission_ milestone must have a _Finish to Finish_ [milestone dependency](/en/lr/24430/#milestone_dependencies) with the country or site-level _Health Authority Approval_ milestone to enable autocompletion. Once you populate the necessary _Health Authority Application_ milestone fields, Vault copies the _Actual Finish Date_ from the _Health Authority Application_ milestone to the _Health Authority Approval_ milestones with connected milestone dependencies. ### EC/IRB Submissions Vault automatically completes the _EC/IRB Approval_ milestone once the _EC/IRB Submission_ milestone meets the following criteria: * The _Actual Finish Date_ field contains a date. * The _Submission Decision_ field value is either _Approved_ or _Approved with Conditions_. _EC/IRB Submission_ milestones complete _EC/IRB Approval_ milestones in two ways, depending on the use of [Multi-Country & Site Submissions](/en/lr/37552/#multi-county-and-site-submission): * If the _Select Specific Country and Site_ field is set to _False_ on the _EC/IRB Submission_ milestone, the country or site-level _EC/IRB Submission_ milestone must have a _Finish to Finish_ [milestone dependency](/en/lr/24430/#milestone_dependencies) with the country or site-level _EC/IRB Approval_ milestone to enable autocompletion. Once you populate the necessary _EC/IRB Submission_ milestone fields, Vault copies the _Actual Finish Date_ from the _EC/IRB Submission_ milestone to all _EC/IRB Approval_ milestones with connected milestone dependencies. * If the _Select Specific Country and Site_ field is set to _True_ on the _EC/IRB Submission_ milestone, then the country-level _EC/IRB Submission_ milestone must have a _Finish to Finish_ milestone dependency with the country-level _EC/IRB Approval_ milestone and a _Milestone Study Site_ record for all _Study Sites_ within the Submission to enable autocompletion. Once you populate the necessary _EC/IRB Submission_ milestone fields, Vault copies the _Actual Finish Date_ from the _EC/IRB Submission_ milestone to the country-level _EC/IRB Approval_ milestones with connected milestone dependencies and the site-level _EC/IRB Approval_ milestones of the _Study Sites_ with _Milestone Study Site_ records. ## How to Set Up Automated Milestone State Changes Vault can automatically move a Milestone to a new state after you update certain fields, without you 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. Enabling this feature automatically enables all available automations. Should any entry criteria prevent Vault from changing the state, the Milestone remains in its present state, and the date is not saved. You must update the record to satisfy any entry criteria are satisfied before you can save the date and change the record's state. ## How to Set Up Excluded Lifestyle States for Milestone Creation {#excluded-lifecycle-states} Vault can use milestone templates to automatically create milestones for _Study_, _Study Country_, and _Study Site_ records. You can restrict the lifecycle states for _Study_, _Study Country_, and _Study Site_ that Vault can create milestones and expected documents in. Navigate to **Admin > Settings > Application Settings** and select the **Prevent Milestone Creation in Excluded Lifecycle States** checkbox in the _Milestones_ section to enable this feature. When you enable _Prevent Milestone Creation in Excluded Lifecycle States,_ you can select excluded lifecycle states for _Study_, _Study Country_, and _Study Site_ records in the picklists. Vault does not create milestones or expected documents for the lifecycle states you select. ## How to Set Up Automated Enrollment Milestones (CTMS) {#automated-enrollment-milestones} 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. ### Configuring Site-Level Milestone Date Locking {#milestone-date-locking} For CTMS Vaults with the Automated Enrollment Milestone feature enabled, you can configure your Vault to lock the _Actual Finish Date_ field on Site-level _Automated Enrollment Milestones_ to prevent users from manually editing system managed _Milestone_ dates for _Studies_ using Date-Based metric calculation. To enable this setting, navigate to **Admin > Settings > Application Settings** and select the **Prevent User Updates to Site Enrollment Milestones Actual Finish Date** checkbox. In Vaults with this setting enabled, users receive an error message when attempting to edit a locked date field. Users must update the date on the corresponding _Subject_ record for the system to update the _Milestone_ date. ## Setting Up Multi-Country and Site Submissions {#multi-county-and-site-submission} Vault allows you to create central Submission milestones that include additional study countries and study sites through the _Milestone Study Country_ (`milestone_study_country__v`) and _Milestone Study Site_ (`milestone_study_site__v`) objects. Leveraging the object associations and setting the _Select Specific Country and Site_ field to _True_ ensures that Vault does not add country and site-level Expected Documents to a Submission milestone until you add a _Study Country_ or _Site_. An Admin must add the _Select Specific Country and Site_ (`select_specific_country_and_site__v`) field to the _Submission_ object types on the _Milestone_ and _Template Milestone_ objects. We recommend adjusting _Template Milestone_ records by setting the **Select Specific Country and Site** checkbox to **True** for submissions where you expect to include additional countries and sites. You must also add the **Milestone Study Countries** and **Milestone Study Sites** application sections to the necessary **Milestone** page layouts to enable the use of _Milestone Study Countries_ and _Milestone Study Sites_ for _Milestones_.  Once you set the **Select Specific Country and Site** field to **True** on a _Milestone_ record, the milestone only generates Expected Documents on the same level as the _Milestone_ record. To have Vault generate Expected Documents for specific _Study Countries_ and _Study Sites_, select **Add** in the **Milestone Study Countries** or **Milestone Study Sites** application section. If you delete a _Milestone Study Country_ or _Milestone Study Site_ record from the _Milestone_, Vault removes the related Expected Documents. For example, a startup specialist prepares a _Central Ethics Submission_ for Country A and sets the _Select Specific Country and Site_ field to _True_. The _Central Ethics Submission Milestone_ has country-level Central Ethics (EC) Application and Informed Consent Form (ICF) expected documents associated with it. A user creates _Milestone Study Site_ records for Site 001 and Site 002. Vault generates Site EC Application and ICF expected documents for Site 001 and Site 002.
## 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_, _Planned_, or _Actual_ date. The workflow uses a system action, _Update Dependent Milestone Dates_, to propagate your changes. Set the _Block Automatic Updates_ field to _Yes_ 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. Vault uses _Actual Start_ and _Actual Finish Date_ values on upstream _Milestones_ to adjust the _Planned_ dates on downstream _Milestones_. The system adjusts the _Planned_ dates to reflect the _Actual_ date plus the _Date Offset_ while preserving the existing _Baseline Start_ and _Baseline Finish Dates_. If a _Planned_ date on a downstream _Milestone_ falls on a Saturday or Sunday, Vault shifts the date to the following Monday.
## Create Milestones at Events {#story_event} 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_: 1. Navigate to the _Story Events_ object through **Admin > Business Admin** or a custom tab. 2. Click **Create**. 3. Fill the required fields. 4. Select a **Level**. 5. 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](/en/lr/30683/) 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 {#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:_ 1. Navigate to the _Template Tasks_ object through **Admin > Business Admin**, a related object, or a custom tab. 2. Click **Create**. 3. Enter a name for the _Template Task_. The _Template Task_ should have a name that will make sense to users. 4. 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. 5. Select a **Category** from the picklist. 6. 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_. 7. Select a **Priority** from the picklist. 8. Select the **Requiredness** of a task for milestone completion. 9. 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 {#about-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 {#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](/en/lr/24430/#dependency_types) to Milestone Rollups to ensure proper completion. ## Milestone Gating {#completeness} 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](/en/lr/22824/): |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_| [3]: #configuring-the-process-global-mapping-action [5]: #mapping-to-global-milestone-types [6]: #about-global-milestone-offsets [7]: #create-milestones-at-events [8]: #how-to-set-up-milestone-autocompletion [9]: #task-templates