Reporting Rule Sets

Vault Safety includes standard Safety Rule Sets, which you can assign to create reporting obligations.

About Standard Safety Rule Sets

Vault Safety comes with Safety Rule Sets for certain standard agencies. Safety Rule Sets are comprised of one (1) or more Safety Rules, which contain rule parameters that define conditions for which a Transmission is generated.

For more information on how the rules engine is triggered to automatically generate Submissions and Distributions, see Understand the Reporting Rules Engine.

The standard Safety Rule Sets are automatically available for customers who have enabled the Evaluate Reporting Obligations action.

When new reporting rules are added, you can configure when to adopt the new rules using the Reporting Rule Version. See Manage Reporting Rule Versions for instructions.

You can assign a Safety Rule Set to an Agency or distribution rule.

The following sections list the Safety Rules and their parameters for each of the standard Safety Rule Sets.

FDA ICSR Reporting Rule Set

Click the following link to download an Excel file with the FDA Reporting Rules, including version 2.0 and 3.0 of the Rule Set:

Download FDA Reporting Rules

For version 1.0 of the FDA Rule Set, used before the 21R1 release (April 2021), see Reporting Rule Sets (20R3 and Earlier).

Version 3.0 of the FDA ICSR Reporting Rule Set contains the following rules:

• Public Health Risk
• Malfunction-Only
• Downgrade to Serious Expected
• Downgrade to Non-Serious
• Downgrade to SAE
• Serious Unexpected
• SUSAR (Death)
• SUSAR (Life Threatening)
• SUSAR
• Serious Expected
• Non-Serious
• One Last Time

EMA ICSR Reporting Rule Set

Click the following link to download an Excel file with the EMA Reporting Rules, including version 2.0 and 3.0 of the Rule Set:

Download EMA Reporting Rules

For version 1.0 of the EMA Rule Set, used before the 21R1 release (April 2021), see Reporting Rule Sets (20R3 and Earlier).

Version 3.0 of the EMA ICSR Reporting Rule Set contains the following rules:

• Downgrade to Non-Serious
• Downgrade to SAE
• Serious
• SUSAR (Death)
• SUSAR (Life Threatening)
• SUSAR
• Non-Serious
• One Last Time

MHRA Rule Set

The MHRA Rule Set inherits the EMA ICSR Reporting Rule Set.

PMDA ICSR Reporting Rule Set

Click the following link to download an Excel file with the PMDA Reporting Rules, including versions 1.0, 2.0, and 3.0 of the Rule Set:

Download PMDA Reporting Rules

The PMDA ICSR Reporting Rule Set contains the following rules:

• INV - 7day - Death - Unexpected
• INV - 7day - LT - Unexpected
• INV - 15day - Serious - Unexpected
• INV - 15day - Serious -Death - Expected
• INV - 15day - Serious - LT - Expected
• PMK - 15day - ADR - Death - Unexpected
• PMK - 15day - ADR - Death - Expected
• INV - 7day - Death - Unexpected - Minor Partial Change - Domestic
• INV - 7day - LT - Unexpected - Minor Partial Change - Domestic
• PMK - 15day - ADR - Serious - Unexpected
• PMK - 15day - ADR - Serious - Expected - Domestic - Recently Approved
• PMK - 30day - ADR - Serious - Expected - Domestic
• PMK - 15day - Serious - Infection
• INV - 15day - Serious - Unexpected - Minor Partial Change - Domestic
• INV - 15day - Serious - Death - Expected - Minor Partial Change - Domestic
• INV - 15day - Serious - LT - Expected - Minor Partial Change - Domestic
• PMK - 15day - NonSerious - Infection - Domestic
• INV - 15day - Research/Safety Measure
• PMK - 30day - Research
• PMK - 15day - Safety Measure
• Downgrade

Template Rule Sets

Vault Safety comes with two (2) template rule sets: the General Distribution Rule Set and the Placeholder (Empty) Rule Set.

You can use these template rule sets as a starting point to set up general distribution rules for a reporting destination such as a partner or other safety system.

General Distribution Rule Set

You can assign the General Distribution Rule Set to an Agency or Partner Distribution List when you need more flexibility than the standard rule sets provide.

The General Distribution Rule Set is assigned the EMA ICSR Rule Set as it’s Base Rule Set, along with additional rules. This means that the General Distribution Rule Set inherits all of the EMA reporting rules.

The rules in the General Distribution rule set exist as a starting point and an example of rules you can configure (such as initial case submission rules). This is not an exhaustive list, nor does it cover every scenario.

Placeholder (Empty) Rule Set

To ensure Vault does not automatically generate Transmissions (Submissions or Distributions) for a reporting destination, you can assign the Placeholder (Empty) Rule Set to an Agency or Partner Distribution List.

The Placeholder (Empty) Rule Set is another configuration example of a rule set without any reporting rules associated with it. Thus, no Transmissions are generated when a Product or Study Registration matches this rule set.

Create Custom Safety Rule Sets

If the standard Vault Safety Rule Sets are unable to cover your particular ICSR submissions to Agencies or Reporting Families, you can create and configure your own custom Rule Sets and then assign them to the required Organization.

To create and configure a custom Rule Set, you must complete the following steps:

1. Create a Safety Rule Set.
2. (Optional) Add Rule Set Parameters to a Custom Rule Set.
3. Add Rules to a Custom Rule Set.
4. Next Steps.

Step 1 - Create a Safety Rule Set

To create a Safety Rule Set, complete the following steps:

1. Go to Business Admin > Objects > Safety Rule Sets.
2. Click Create.
3. Enter the information described in the table below.
4. Click Save.

Field	Description
Name	(Required) Enter a name for the Rule Set.
Base Rule Set	If you do not want to inherit any Rules from a Base Rule Set, leave this field blank. You can add Rules to the Rule Set in step 3 below. If you want to create a Rule Set based on an existing Rule Set, select that Rule Set from the dropdown list. Your custom Rule Set will inherit the Rules and Rule Parameters of the selected Base Rule Set. See the previous sections of this article for a description of Vault-provided Rule Sets you can select as a base for your new Rule Set. Note: If you select a Base Rule Set, the Base Rule Set’s Rules will not appear in the list of Rules in your new Rule Set. The list will be empty until you add new Rules. See How to Remove an Overridden Rule Parameter and the Overridden Rule field below for help modifying inherited Base Set Rules.
Eligibility Criteria	Leave this field blank.
API Name	Enter an API name.
Active Rule Version	Leave this field blank.

Result

Vault creates a new custom Safety Rule Set.

Step 2 - Add Rule Set Parameters to a Custom Rule Set

Rule Set Parameters are Rule Parameters that apply to all the Rules in your custom Rule Set.

For any Rule in your Rule Set to generate a Transmission, all of the parameters in the Rule and any Rule Set Parameters must evaluate as “True”.

For example, your custom Rule Set is for a specific agency that requires reports for only Suspect Products. If you add the Suspect Rule Set Parameter that specifies the Product must be Suspect, then you do not need to add the Suspect Rule Parameter to each of the Rules in your Rule Set.

Rule Set Parameters appear in the Safety Rule Parameters section of a Rule Set.

Add a Rule Set Parameter to a Rule Set

Complete the following steps for all the Rule Set Parameters your Rule Set requires.

1. Go to Business Admin > Objects > Safety Rule Sets.
2. Select the Rule Set.
3. In the Safety Rule Parameters section, click Create.
4. Enter the information described here.
5. Click Save.

Result

Your custom Safety Rule Set now contains records for all the required Rule Set Parameters.

Field	Description
Parameter	(Required) Select the required parameter from the dropdown list. For a description of the available parameters, see Reporting Rule Parameters.
Value	(Required) Enter the value for the selected parameter. See Reporting Rule Parameters for help with specifying the value for a given parameter. Note: If the Value you entered is invalid for the selected Parameter, you will receive an error message when you save the Safety Rule Set Parameter record.

Step 3 - Add Rules to a Custom Rule Set

To create and configure Rules for a Rule Set, complete the following steps:

1. Add a Safety Rule to a Custom Safety Rule Set.
2. Add Rule Parameters to a Safety Rule.

Step 3.1 - Add a Safety Rule to a Custom Safety Rule Set

To add a Safety Rule to a custom Rule Set, complete the following steps:

1. Go to Business Admin > Objects > Safety Rule Sets.
2. Select the Rule Set.
3. In the Rules section, click Create.
4. Enter the information described here.
5. Click Save.

Result

Your custom Rule Set now contains a new Rule.

Field	Description
Name	(Required) Enter a name for the Safety Rule.
Rule Priority	(Required) Enter this Rule's priority as a number between 1 and 100. The priority determines the execution order of the Rules in a Rule Set, starting with the smallest number first. Note: If you create one or more Rules with the same Priority, the Safety Rules Engine will execute them in the creation date order.
Evaluation Function	Select Classify Case from the dropdown list.
Execution Function	Select Create Transmission from the dropdown list.
Overridden Rule	If you selected a Base Rule Set when you created your custom Rule Set and you need to modify one of the Base Set's Rules, select the Rule from the dropdown list. The rules that appear in the dropdown list depend on the Base Rule Set you selected. See the Parameter field in Step 3.2 below for more information on modifying inherited Rule Parameters.
Rule Status	Select Active. If you want to disable a rule without deleting it, select Inactive.

Step 3.2 - Add Rule Parameters to a Safety Rule

Once you have created a new Safety Rule, add the required Rule Parameters for that rule as follows:

1. Go to the Safety Rule you created in the previous step. In the Rule Parameters section, click Create.
2. Enter the information described here.
3. Click Save.
4. Repeat these steps to add all the Rule Parameters required for this Rule.

Result

Your Safety Rule now contains all the required Rule Parameters.

You now have a custom Rule Set complete with your configured Rules and Rule Set Parameters.

Field	Description
Parameter	Select the required parameter from the dropdown list. For a description of the available parameters, see Reporting Rule Parameters. Each Rule must have a Rule Parameter that defines the Due Date. Acceptable Rule Parameters to define a due date are either of the following: Due in Days Previously Submitted Rule Parameters from Overridden Rules If the Rule for this Rule Parameter overrides a Base Rule Set (see Overridden Rule), then any Rule Parameters you add to this Rule will be used in addition to the Rule Parameters of the selected Overridden Rule. Ensure you do not add Rule Parameters to your custom Rule that conflict with those of the Overridden Rule. For example, if the Overridden Rule contains a Rule Parameter for "Suspect = Yes", do not add a Rule Parameter to your custom Rule for "Suspect = No". How to Remove an Overridden Rule Parameter To remove a Rule Parameter inherited from an Overridden Rule, select that parameter from the dropdown list, then enter two (2) dashes (--) in the Value field.
Value	Enter the value for the selected parameter. See Reporting Rule Parameters for help with specifying the value for a given parameter. Note: If the Value you entered is invalid for the selected Parameter, you will receive an error message when you save the Safety Rule Parameter record.

Next Steps

Once you have created your custom Rule Set, consider the following next steps:

1. Assign the Rule Set to an Agency or Reporting Family.
2. Complete any remaining Rule Set configuration, such as a Transmission Profile. See Understand the Reporting Rules Engine for more information.
3. Test your custom Rule Set to ensure your configuration is correct.

Generate a Safety Rule Set Configuration Report

To review a Rule Set’s Rules and Rule Parameters in an easy-to-read format you can generate a Safety Rule Set Configuration Report. If required, you can generate this report for multiple Rule Sets simultaneously.

Once Vault has generated the Safety Rule Set Configuration Report, you can download the report as an XLSX file.

For instructions on how to generate and download this report, see Generate a Safety Rule Set Configuration Report for a Single Rule Set and Generate a Safety Rule Set Configuration Report for Multiple Rule Sets

About the Safety Rule Set Configuration Report

A Safety Rule Set Configuration Report contains the following sections (shown as tabs in the downloaded XLSX file):

• Cover Page: This contains information about who generated the report, when it was generated, and from which Vault.
• Table of Contents: Lists the total count of Safety Rules.
• Safety Rules: This contains the details of the Rules and Rule Parameters contained in the Rule Sets, described below.

The Safety Rules tab contains a row for each of the Rules in your Rule Set. Each row contains columns that display the following information:

• The Rule’s name
• The Rule Set the Rule belongs to
• Whether the Rule is active or inactive
• The Rule’s priority
• The names of any Overidden Rule or Rule Set Parameters
• The name of the Evaluation Function
• The name of the Execution Function

The remaining columns identify each of the Rule Parameters in the Rule. The number of remaining columns depends on the number of Rule Parameters defined in each Rule. Each of these columns can contain one (1) of the following values:

1. The value specified in the Rule Parameter’s Value field.
2. Blank (empty). This indicates the Rule Parameter’s Value field is empty.
3. A double dash (--). This indicates that the Rule Parameter’s value was overridden to blank (empty). This typically applies to a Rule Parameter inherited from a Rule Set Parameter, Base Rule Parameter, or Base Rule Set Parameter.

As with the Reporting Rule Engine, the Safety Rule Set Configuration Report always contains the Rules and Rule Parameters that are defined at the lowest level of inheritance. The following list shows the order of inheritance for Rule Set Parameters and Rule Parameters:

1. Base Rule Set Parameters (highest level)
2. Base Rule Parameters
3. Rule Set Parameters
4. Rule Parameters (lowest level)

See Understand the Reporting Rules Engine for more information on how the Reporting Rule Engine functions.

Generate a Safety Rule Set Configuration Report for a Single Rule Set

Complete the following steps to generate a Safety Rule Set Configuration Report for a single Rule Set:

1. Go to Business Admin > Objects > Safety Rule Sets.
2. Select or hover over the Rule Set.
3. Select the All Actions menu and select Generate Rule Set Configuration Report.

Result

Vault generates a single report containing the Rules and Rule Parameters for the selected Rule Set. Vault also sends you a notification and email. You can download the report from either the notification or the email.

Generate a Safety Rule Set Configuration Report for Multiple Rule Sets

Complete the following steps to generate a Safety Rule Set Configuration Report for multiple Rule Sets:

1. Go to Business Admin > Objects > Safety Rule Sets.
2. Select the All Actions menu, then under Perform Bulk Action, select All [number] records.
   You can refine your selection in the next step.
3. (Optional) Clear the checkboxes for the respective Rules to exclude these Rules from the report.
4. Select Next.
5. Under Manage Records, select Record Actions, then select Next.
6. Select Generate Rule Set Configuration Report (affects all records), then select Next.
7. Review the Confirmation information. If everything is correct, select Finish.

Result

Vault displays a message that it is performing bulk updates. Vault notifies you when the the Bulk Record User Action for the Generate Rule Set Configuration Report is complete and the number of successful generations. Vault sends a second notification when the Safety Rule Set Configuration report is complete. You can download the report from either the notification or the email. This report includes the Rules and Rule Parameters for each of the Rule Sets you selected in step 3.

Override Study Reporting Rules

By default, Case due dates follow the FDA or EMA reporting rules, depending on the case criteria. To override Case due date calculations, add a Submission Rule Override.

1. Go to the Study record page. Find Study records on the Business Admin > Objects > Studies page.
2. Select Edit.
3. Expand Submission Rules.
4. Beside Due Date Override, select Yes.
5. To override the submission rule for adverse events that are life-threatening or result in death, edit the 7 Day Override field.
6. To override the submission rule for other serious adverse events, edit the 15 Day Override field.
7. Select Save.

Result

When Vault calculates due dates for Cases linked to this Study Registration, the due dates follow the Submission Rule Override settings configured on the Study Registration.