**Source URL:** https://safety.veevavault.help/en/lr/1118355/index.md # Create Signal Detection Plans _Signal Detection Plans_ provide a centralized area for monitoring product safety and the methodology or strategy for how to perform signal detection for a _Product Family_, _Aggregate Reporting Group_, or _Products_ of a _Therapeutic Area_. Each _Signal Detection Plan_ defines the frequency of review, the medical terms to look for, the databases to search, the users who will perform the review, and more.  You can assign a [_Signal Product Tier_][1] to a [_Signal Detection Plan_][2] to categorize the products of interest by risk, which can be determined based on the product's age, the volume of cases, whether the product is postmarket or undergoing clinical trials, and other factors. ## Prerequisite Before you can use this feature, your Admin must enable _Signal Detection Plans_. ## Create Signal Product Tiers {#product-tier} Create _Signal Product Tiers_ to categorize the risk level for _Products_ based on your business processes:  1. Navigate to the **Signal Product Tiers** tab. 2. Select **Create**. 3. On the _Create Signal Product Tier_ page, enter a _Name_ for this risk level.  4. Select **Save**.    Next, [create _Signal Activities_][3] for the _Signal Product Tier_. ## Create Signal Activities {#activities} Create _Signal Activities_ to set the frequency of review and the search criteria for the _Signal Product Tier_'s risk level:  1. In the _Signal Product Tier_, expand the **Activities** section.  2. From the _Signal Activity_ dialog, select one of the following types from the drop-down and then select **Continue**: * **Individual Case Review**: Routine reviews based on specific criteria that are part of qualitative signal detection and analysis * **Literature Review**: Routine monitoring of scientific literature * **Qualitative Review**: Report-based reviews, for example, pregnancy cases * **Quality Review**: Product quality reviews * **Quantitative Review**: Statistical analysis reviews, for example, disproportionality scores from a Safety database or an external database such as FAERS 3. Complete the [applicable fields][4] and select **Save**.  Upon saving the record, Vault displays a number of new sections depending on the _Signal Activity_ type. Complete the following child records as applicable:  * [_Signal Activity Search Criteria_][5] * [_Signal Activity Data Sources_][6] * [_Signal Activity Product Identifiers_][7] * [_Signal Activity Alert Rule Sets_][8] * [_Signal Activity Case Routing Criteria_][9] ### Signal Activity Fields {#activity-fields} The following fields may be available depending on the _Signal Activity_ type:  | Field | Description | | ----------------------- | ----------------------------------------- | | _Description_ | Enter a description for the _Signal Activity_. | | _Aggregate Reporting Group_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select an _Aggregate Reporting Group_ from the drop-down or use the **Advanced Search** (binoculars icon) icon to use filters and refine your search. | | _Product Family_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select a _Product Family_ from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Activity Schedule_ | Select the frequency of review from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Case States to Include_ | Select the required lifecycle states for _Cases_ to be included in the results. | | _Activity Review Due in Days_ | Enter the number of days the assigned user will have to complete the review from the start date. | | _Schedule Start Date_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select the start date for the _Signal Activity_ schedule. | | _Default Calculations Setting_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select a _Signal Calculations Setting_ from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Default Workbench Report Set_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select a _Workbench Report Set_ from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Signal Product Profile_ | If creating this _Signal Activity_ for a _Signal Product Tier_, leave this field blank. 

If creating this _Signal Activity_ for a _Signal Detection Plan_, select a _Signal Product Profile_ from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | ### Signal Activity Search Criteria {#activity-search-criteria} Configure search criteria on the _Signal Activity_ to define detection at the _MedDRA Query_ or _Watchlist_ level:  1. In the _Signal Activity_, expand the **Search Criteria** section.  2. Select **Add**. 3. In the _Signal Search Criteria_ window, add existing search criteria or select **Create** to create new ones with the following information: * **Description**: Enter a description for the search criteria. * **Search Strategy Summary**: Enter a summary for the search strategy. * **MedDRA Query**: Select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. * **Watchlist**: Select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. * **Data Fields**: Enter field data to further specify the strategy for producing report and calculation results. The following lists some examples, depending on the level of detail you need to capture:  * To identify pregnancy cases, enter `Case Version > Pregnancy = Yes` * To identify fatal cases, enter `case_version__v.date_of_death__v is not blank` or enter `Case Version > Autopsy count > 1` 4. Select **OK**. ### Create Signal Data Sources {#data-sources} Define the _Signal Data Sources_ to which this _Signal Product Tier_ applies:  1. In the _Signal Product Tier_, expand the **Data Sources** section. 2. Select **Create**.  3. In the _Create Signal Activity Data Source_ dialog, select a _Signal Activity_ from the drop-down and then select **Continue**. 4. In the _Create Signal Activity Data Source_ window, complete the following information:  * **Signal Source**: Select a source from the drop-down or use the **Advanced Search** icon to use filters and refine your search. * **Signal Source Data**: Depending on the _Signal Source_, select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. 5. Select **Save**.  ### Create Signal Activity Product Identifiers {#activity-product-identifiers}
_Signal Activity Product Identifiers_ map products from external databases (for example, EVDAS) to _Signal Activities_. To create _Signal Activity Product Identifiers_: 1. In the _Signal Product Tier_, expand the **Product Identifiers** section. 2. Select **Create**.  3. In the _Create Signal Activity Data Source_ dialog, select a _Signal Activity_ from the drop-down and then select **Continue**. 4. In the _Create Signal Activity Product Identifier_ window, complete the applicable fields. ### Create Signal Activity Alert Rule Sets {#activity-alert-rule-sets}
To configure _Signal Alert Rule Sets_ for the _Signal Product Tier_: 1. In the _Signal Product Tier_, expand the **Signal Alert Rule Sets** section. 2. Select **Create**.  3. In the _Create Signal Activity Alert Rule Set_ dialog, select a _Signal Activity_ from the drop-down and then select **Continue**. 4. On the _Create Signal Activity Alert Rule Set_ window, select a _Signal Alert Rule Set_ from the drop-down or select **Create** and populate the **Signal Alert Rule Set Name** field to create a new _Signal Alert Rule Set_. ### Create Signal Activity Case Routing Criteria {#activity-case-routing-criteria} Configure _Signal Activity Case Routing Criteria_ to flag _Cases_ for review and apply _Case_ actions: 1. In the _Signal Activity_, expand the **Case Routing Criteria** section.  2. Select **Create**. 3. In the _Create Signal Activity Case Routing Criteria_ window, select an _Individual Case Routing Criteria_ from the drop-down or create new ones by completing the applicable fields.  ## Create Signal Detection Plans {#signal-detection-plans} To create a _Signal Detection Plan_:  1. Navigate to the **Signal Detection Plans** tab. 2. Select **Create**.  3. On the _Create Signal Detection Plan_ page, complete the [applicable fields][10]. 4. Select **Save**. Upon saving the _Signal Detection Plan_, Vault displays a number of new sections on the object. Complete the _Signal Detection Plan_ using the following overview:  1. After populating the _Plan Details_ and _Product Details_, you can complete the rest of the _Signal Detection Plan_ by copying the _Signal Activities_ from the assigned _Signal Product Tier_:  1. In the _Signal Detection Plan_, expand the **Product Details** section and select the _Tier_. 2. In the _Signal Product Tier_, expand the **Activities** section.  3. From the record's **All Actions** menu, select **Copy Record**.  4. Clear the _Tier_ and set the **Signal Detection Plan** and then select **Save**. 5. After saving the record, on the _Hierarchical Copy Option_ dialog, select **Copy Related Records**.  6. [Populate fields][4] as needed. \ You can also manually [create][3] these records on the _Signal Detection Plan_. 2. From the **Workflow State Change** menu (workflow state change icon), select **Change State to In Review** to let the appropriate reviewers know the _Signal Detection Plan_ is ready for review. 3. After the review is complete, from the **Workflow State Change** menu, the appropriate users will select **Change State to Approved** and provide signatures as needed. ### Signal Detection Plan Fields {#signal-detection-plan-fields} The following fields may be available:  | Field | Description | | ----------------------------------- | ------------------------------------------- | | _Name_ | Enter a name for the plan. | | _Description_ | Enter a description for the plan. | | _Plan Version Effective Date_ | Select the date and time the plan starts. | | _Plan Version Summary_ | This document captures the approved _Signal Detection Plan_ version. You must first save the _Signal Detection Plan_ before populating this field. Select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Plan End Date_ | Upon inactivating the plan, select the date the plan ends. | | _Plan Inactivation Reason_ | Upon inactivating the plan, enter a reason for the inactivation. | | _Aggregate Reporting Group_ | Select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Product Family_ | Select an option from the drop-down or use the **Advanced Search** icon to use filters and refine your search. | | _Therapeutic Area_ | Vault may populate this field from the _Product Family_. Otherwise, select the areas in which this plan applies. | | _Tier_ | Select a [_Signal Product Tier_][1] from the drop-down. Upon saving, Vault links the _Signal Detection Plan_ to the _Detection Plans_ section of the selected _Signal Product Tier_. | | _Product Surveillance Start Date_ | Select the start date of the surveillance period for the product. | | _Product Surveillance End Date_ | Select the end date of the surveillance period for the product. | [1]: #product-tier [2]: #signal-detection-plans [3]: #activities [4]: #activity-fields [5]: #activity-search-criteria [6]: #data-sources [7]: #activity-product-identifiers [8]: #activity-alert-rule-sets [9]: #activity-case-routing-criteria [10]: #signal-detection-plan-fields