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 to a Signal Detection Plan 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

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 for the Signal Product Tier.

Create Signal 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 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
• Signal Activity Data Sources
• Signal Activity Product Identifiers
• Signal Activity Alert Rule Sets
• Signal Activity Case Routing Criteria

Signal 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 () 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

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

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

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

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

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

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.
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 as needed.
      You can also manually create these records on the Signal Detection Plan.
2. From the Workflow State Change menu (), 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

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 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.