Sections in This Article
About the Reporting Rules Engine
Vault Safety provides a reporting rules engine that simplifies the process of managing Individual Case Safety Report (ICSR) reporting obligations. Admins can set up reporting rules with regulatory agencies, partners, study sites, and market authorization holders.
When the Evaluate Reporting Obligation runs on a Case, either through auto-Submissions or when the Case enters the Approved state, Vault Safety’s reporting rule engine automatically generates and assigns due dates for Submissions and Distributions.The rules engine comprises of the following parts:
|Safety Rule Sets||A Safety Rule Set is a collection of reporting rules (Safety Rules), which can be assigned to an Agency for Submissions, or a Reporting Family for Distributions.|
|Rule Parameters||Reporting rules are comprised of rule parameters that define the conditions for which a Transmission is generated.|
|Transmission Profiles||Transmission Profiles are used to generate Submissions and Distributions for an origin-and-destination pair with the appropriate ICSR file format.|
Vault Safety provides Safety Rule Sets, Safety Rules, and Transmission Profiles for certain standard agencies, such as FDA, EMA, and PMDA.
The Submission Rules (
submission_rules__v) field on an Agency assigns a Safety Rule Set to an Agency.
To generate a Submission for an Agency, the rules engine must evaluate a 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.
When evaluating reporting obligations, the system looks at the country selection on Case Registrations. For general reporting, the system looks at the following registrations by report type:
- For Cases with a non Study Report Type, the system evaluates the Case Product Registrations.
- For Cases with a Report Type of Study, the system evaluates the Study Registrations.
However, if the Study Has Unspecified Products field is selected on the associated Study, the system evaluates the Case Product Registrations instead for Cases involving that Study.
Tip If cross reporting is enabled, after Submissions are generated for general reporting, the system evaluates additional investigational or marketing registrations associated with the Case.
The following illustration shows how Vault Safety evaluates regulatory reporting requirements for general reporting:
- Case 00245 is entered and approved. The Case contains the primary Case Product 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. The system proceeds to evaluate the FDA rule set to generate an FDA Submission.
- Germany: This country's jurisdiction is the EMA. The system 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. The system 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.
- The system generates Submission records for the Case using the matching rules, and populates the due date and other fields on the Submission accordingly. The system generates the transmission document in the appropriate format for submission.
Assign a Safety Rule Set to a Reporting Family to automatically generate Distributions for trading partners. Vault Safety supports two 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__vfield 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 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.