# Understand the Reporting Rules Engine Safety's Reporting Rules Engine simplifies the process of managing Individual Case Safety Report (ICSR) reporting obligations. The Reporting Rules Engine comprises of the following parts: * **Safety Rule Sets**: Collections of reporting rules (_Safety Rules_ and _Safety Rule Parameters_) which can be assigned to an _Agency, Market Authority Holder (MAH), or Reporting Family_. * **Safety Rules**: Reporting rules containing one or more _Safety Rule Parameters_ that define the conditions for which a _Transmission_ is generated. * **Active Rule Version**: The _Active Rule Version_ of a _Safety Rule Set_ indicates to the Reporting Rules Engine which of the set's _Safety Rules_ to execute when evaluating a _Case_. * **Transmission Profiles**: Generates _Transmissions_ for an origin-and-destination pair with the appropriate ICSR file format. Admins can set up _Safety Rule Sets, Safety Rules,_ and _Transmission Profiles_ for regulatory agencies, partners, study sites, and market authorization holders such that when the Reporting Rules Engine runs on a _Case_, Vault creates the necessary _Transmissions._ Note: Vault provides _Safety Rule Sets_, _Safety Rules_, and _Transmission Profiles_ for certain standard agencies, including the FDA, EMA, MHRA, and PMDA. The following actions trigger the Reporting Rules Engine to run on a _Case_: * [Evaluate Early Notification Obligations][3] * [Evaluate Reporting Obligations][4] Depending on your Vault's configuration, you can trigger these actions manually or Vault can trigger them through the _Case_ lifecycle. ## Evaluate Early Notification Obligations {#eeno} When the _Evaluate Early Notification Obligations_ action runs on a _Case_, Vault generates _Early Notification Reports_ as required. For more information on _Early Notification Reports_, see ICSR Transmissions Overview and Create an ICSR Transmission. ## Evaluate Reporting Obligations {#ero} When the _Evaluate Reporting Obligation_ action runs on a _Case_, Vault generates and assigns due dates (and [approval due dates][5], if configured) for _Submissions_ and _Distributions_ as required. For more information on _Submissions_ and _Distributions_, see ICSR Transmissions Overview and Create an ICSR Transmission ## Submission Rules The _Submission Rules_ field on an Agency assigns a _Safety Rule Set_ to an _Agency_. While certain standard agencies are preconfigured with a _Submission Rule_, you can assign _Submission Rules_ to additional _Agencies_. To generate a _Submission_ for an _Agency_, the rules engine must evaluate an active _Product Registration_ or _Study Registration_ for a country within the _Agency_'s jurisdiction. The _Agency_ field on the associated _Country_ record identifies which regulatory agency has jurisdiction over that country.

Note: If a Product has multiple Product Type registrations based on agency requirements, you can create country-specific Product Registrations.

When evaluating reporting obligations, Vault looks at the country selection on _Case Registrations_. For general reporting, Vault looks at the following registrations by report type: * For _Cases_ with a non-Study type of report, Vault evaluates the active _Product Registrations_. * For _Cases_ with a _Report Type_ of _Study_, Vault evaluates the active _Study Registrations_. However, if the _Study Has Unspecified Products_ field is selected on the associated _Study_, Vault evaluates the active _Product Registrations_ instead for _Cases_ involving that _Study_.

Note: After Vault generates Submissions for general reporting, Vault evaluates additional investigational or marketing registrations associated with the Case for the purposes of Cross Reporting.

### FDA Registration Details {#fda} For automatically generated _Submissions_ to the FDA, Vault populates the appropriate [product][1] or [study][2] registration details based on existing registrations. Vault does not populate FDA registration details for any _Submissions_ generated through _Transmission Output Templates_. #### Product Registrations {#product-registrations} For _Submissions_ generated based on _Product Registrations_ for non-study types of _Cases_, Vault populates the following registration fields differently for general reporting and cross reporting: * **General Reporting** * **Reportable Product**: The passing _Product_ of the _Case_ * **Reportable Product Registration**: Assigned based on the following priority of marketing _Product Registrations_ for the _Reportable Product_: 1. Earliest _Registration Date_ 2. Lowest _Registration Number_ 3. Earliest _Created Date_ * **Cross Reporting** * **Reportable Product Registration**: Assigned based on the following priority of existing FDA marketing _Product Registrations_: 1. Shortest _Due in Days_ 2. Earliest _Registration Date_ 3. Lowest _Registration Number_ 4. Earliest _Created Date_ * **Reportable Product**: The _Product_ of the _Reportable Product Registration_ When evaluating _Product Registrations_ for a _Case_ that contains an unknown formulation _Product_, Vault considers all _Product Registrations_ within the _Product Family_. When evaluating _Registration Numbers_ of existing _Product Registrations_ to determine the lowest number, Vault ignores any letters in the field values. For example, "C123" is lower than "A321". #### Study Registrations {#study-registrations} For _Submissions_ generated based on _Study Registrations_ for study types of _Cases_, Vault populates the following registration fields for general reporting: * **Reportable Product**: The passing _Product_ of the _Case_ * **Reportable Study Registration**: Assigned based on the following priority for the _Study_ of the _Case_: 1. Lowest _Registration Number_ 2. Earliest _Created Date_ * **Reportable Study**: The _Study_ of the _Case_ when the case is a Clinical Trial Study When evaluating _Registration Numbers_ of existing _Study Registrations_ to determine the lowest number, Vault ignores any letters in the field values. For example, "C123" is lower than "A321". ### General Reporting Example {#example} The following illustration shows how Vault Safety evaluates regulatory reporting requirements for general reporting:

Evaluating Submission Reporting Rules for a Case

_Case_ 00245 is entered and approved. The _Case_ contains the primary _Case Product_ of `Cholecap`. The _Case_ triggers the reporting rules engine by moving to the _Approved_ state.

To determine regulatory reporting requirements, the reporting rules engine evaluates Cholecap's _Product Registrations_. \ Cholecap has _Product Registrations_ for the following countries: * **United States**: This country's jurisdiction is the FDA. Vault proceeds to evaluate the FDA rule set to generate an FDA _Submission_. * **Germany**: This country's jurisdiction is the EMA. Vault proceeds to evaluate the EMA rule set to generate an EMA _Submission_. * **France**: This country's jurisdiction is also the EMA. No further _Submissions_ are generated because another EMA registration is already being evaluated. Vault generates a single _Submission_ when there are multiple registrations with the same agency jurisdiction.

For each rule set, the rules engine iterates through the rules in order. Each rule consists of parameters that define how it is evaluated. Each parameter is evaluated against _Case_ information. When all parameters of a rule are evaluated successfully, the rule is considered a match, and no other rules are evaluated for that rule set.

Vault generates _Submission_ records for the _Case_ using the matching rules, and populates the due date and other fields on the _Submission_ accordingly. Vault generates the transmission document in the appropriate format for submission. ## Distribution Rules Assign a _Safety Rule Set_ to a _Reporting Family_ to automatically generate _Distributions_ for trading partners. Vault Safety supports the following types of _Reporting Families_ for _Distributions_: * **Partner Distribution List**: You can create a _Partner Distribution List_ to automatically generate _Distributions_ for partners or sites. * **MAH Distribution List**: Assigned through the _Reporting Organization_ field on a _Product Registration_ or _Study Registration_, an _MAH Distribution List_ generates a _Distribution_ to a market authorization holder (MAH) in place of generating a _Submission_ to an agency.

Note: In the event where both a Reporting Obligation and one or more Partner Distribution Rules exist for a single active Product Registration or Study Registration, Vault Safety creates a Distribution record for each reporting rule, including when both reporting rules are to the same destination.

## Case Approval Due Date Calculation {#case-approval-dd-calc} If the Case Approval Due Date feature is configured in your Vault, on reportable _Cases_ other than OLT reports, Vault populates _Approval Due Dates_ based on the _Approval Due in Days_ and _Due in Days_ reporting rule parameters of the passing reporting rules as follows: * If at least one reporting rule with an _Approval Due in Days_ rule parameter passes, across all passing reporting rules, Vault calculates the _Approval Due Date_ based on the _New Info Date_ + the lowest _Approval Due in Days_ or _Due in Days_ value. * If no passing reporting rules includes an _Approval Due in Days_ rule parameter, Vault populates the _Due Date_ of the _Case_. For OLT reporting, Vault populates _Approval Due Dates_ on _Cases_ as follows: * For OLT reporting alone, Vault maps the _Approval Due in Days_ value from the previous _Transmission_ to calculate the _Approval Due Date_. If _Approval Due in Days_ is blank, Vault populates the _Due Date_ of the _Case_. * For OLT reporting when general or cross reporting to another destination is also required, Vault considers the lowest _Approval Due in Days_ or _Due in Days_ value across all _Transmissions_, including OLT _Transmissions_. For non-reportable _Cases_, Vault populates _Approval Due Dates_ as follows: * If the _Case_ includes a _Seriousness_ value, Vault calculates the _Approval Due Date_ based on the _New Info Date_ + 15 days * Otherwise, Vault calculates the _Approval Due Date_ based on the _New Info Date_ + 30 days After calculating _Approval Due Dates_, Vault populates the reporting rule with the lowest _Approval Due in Days_ and _Due in Days_ values in the _Approval Due Date Rule_ _Due Date Rule_ fields on the _Case_ using the format `(Current Date): Rule Set={Safety Rule Set Name}, Rule={Safety Rule Name}, Reporting Scenario={Reporting Scenario}`, where `{Reporting Scenario}` indicates either `General Reporting` or one of the cross-reporting scenarios depending on the configuration of the passing rule's _Reporting Scenario_ rule parameter. ## Download the Submission Rule Log for a Case {#submission-rule-log} When either of the _Evaluate Reporting Obligations_ or _Evaluate Early Reporting Obligations_ actions runs on a _Case_ (whether manually or automatically as part of the _Case_ workflow), Vault keeps a log of which _Destinations_ were evaluated (_Agencies_ or _Partners_ for _Early Notifications_, _Agencies_ for _Submissions_, _Partners_ for _Distributions_). It also logs the names of any _Transmission Output Templates_ used and whether the _Case_ passed one (1) or more of the associated _Destination's_ safety rules. You can access this log from the **All Actions** menu of a _Case_ by selecting **Download Submission Rule Log**. The log is in CSV format. Once downloaded, you can open the file in a text editor or spreadsheet application.

Note: If you experience unexpected behavior when generating Transmissions, such as an Early Notification, a Submission, or a Distribution not generating when it should, your Admin can use the Troubleshooting Safety Rules article to help diagnose and fix the Safety Rules in your Vault.

[1]: #product-registrations [2]: #study-registrations [3]: #eeno [4]: #ero [5]: #case-approval-dd-calc