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About Safety Rules
The Safety Rules in a Safety Rule Set define the conditions for which a Transmission is generated. Each Safety Rule has a set of parameters. The parameters must evaluate successfully for the rule to pass.
A Safety Rule’s Priority defines the order in which the system attempts to match each reporting rule, which are processed from lowest to highest. To prevent over-reporting, once the system finds the first matching rule, further rules are not evaluated.
The following image shows an example of a Safety Rule:

The following sections describe the parameters the system supports for Safety Rules.
For relevant parameters, the table identifies how the system evaluates parameters according to the Product Selection setting on the rule set. See Configure Reporting Rules Product Selection for more information.
Note The system uses one method to evaluate each rule set parameter. If an admin set the Product Selection to use the most conservative evaluation, the system uses this method for parameters identified below.
Reporting Rule Parameters
The following table describes the reporting rule parameters that the system evaluates. The Type column identifies whether a parameter is an input or output parameter. Input parameters evaluate Case criteria to find a matching rule. Output parameters control how the Transmission is generated.
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Report Type | Input |
The Case's Report Type ( The value must be a report type that is configured in the Controlled Vocabulary and has an E2B Code. |
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Study Type | Input |
The Case's Study Type ( The EMA rule set uses the Study Type parameter to differentiate between clinical trials and other study types. The value must be a study type that is configured in the Controlled Vocabulary and has an E2B Code. Note If the Study Type value on the Case is left blank, this parameter will be regarded as a Clinical Trial. |
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Serious | Input | Whether the case meets seriousness criteria. The system evaluates this parameter using the method specified on the rule set:
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Life Threatening | Input | Whether the case meets life-threatening seriousness criteria. The system evaluates this parameter using the method specified on the rule set:
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Fatal | Input | Whether the case meets fatal seriousness criteria. The system evaluates this parameter using the method specified on the rule set:
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Expected | Input | Locates the relevant Case Assessment Expectedness records based on the evaluation method specified on the rule set:
The system uses logic to evaluate the appropriate Expectedness records for this parameter. To see the detailed logic, click the button below: The system first looks for Expectedness records under the relevant Case Assessment, then executes the following logic depending on whether the Case is part of a Study:
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Suspect | Input | The Drug Role (drug_role__v ) field on the relevant Case Product. This parameter is evaluated as "Yes" when the Drug Role is either Suspect or Interacting. |
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AE in Jurisdiction | Input | Evaluates whether the adverse event occurred in the agency's jurisdiction. The system evaluates this parameter using the method specified on the rule set:
You can view the countries in an agency's jurisdiction by going to the Agency-type Organization record in the Business Admin area. |
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Exclude | Input |
Evaluates whether the system excludes placebos when evaluating suspect Case Products for a Study Case. This parameter accepts "Placebo" as an acceptable value. Note Submission rules to not apply to Study Products with a Study Product Role of Placebo. Once unblinding is completed, if all Case Products are placebos, Submissions are not generated. |
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Assessment Criteria | Input | Evaluates whether the Case meets SUSAR or SAE criteria. The system evaluates this parameter using the method specified on the rule set:
This parameter accepts "SUSAR" or "SAE" as acceptable values. Vault Safety automatically assigns case and assessment tags. See How Case SAE and SUSAR Tags are Assigned for more information. |
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Assessment Source | Input | Evaluates the Case Assessment Source in relation to the Related rule parameter, to consider the source of a causality assessment. This parameter is evaluated as "True" when both Source Type matches this parameter and the Related parameter is evaluated as "Related". The system evaluates this parameter using the method specified on the rule set:
The system evaluates this parameter using the Controlled Vocabulary E2B Code corresponding to the Source Type ( |
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Device Report Type | Input |
The Case Device Report Type ( This parameter accepts "Public Health Risk" or "Malfunction Only" as acceptable values. |
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Downgrade | Input and Output |
Evaluates whether the current Case's seriousness, expectedness, and relatedness are downgraded from the previous Case version. The current Case’s Most Conservative Product/Assessment (MCP/MCA) is compared against the previous Case version, based on one of the following priority lists: If your Admin has not enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:
If your Admin has enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:
If the current Case scenario is lower on the priority list than the previous Case version, this parameter is evaluated as "Yes". This parameter also controls whether the Downgraded flag on the Transmission is turned on. |
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Transmission Reason | Input and Output | This parameter is evaluated using the previous Transmissions to the same reporting destination and sets the Reason (
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Registration Type | Input | The Registration Type ( The value must be a registration type that is configured in the Controlled Vocabulary. This parameter is used in PMDA reporting rules. |
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PMDA Reporting Category | Input |
The PMDA Reporting Category ( This parameter accepts a comma separated-list of the active values from within the PMDA Reporting Category Picklist. |
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Infection | Input | Evaluates whether the Case is designated as an infection. This parameter is used in PMDA reporting rules. The system uses the following logic to evaluate this parameter:
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Related | Input | Evaluates whether a causality assessment categorized the adverse event as related to the suspect product. The system evaluates this parameter using the method specified on the rule set:
This parameter is evaluated as "Related" when the relevant Case Assessment contains at least one Case Assessment Result with the Causality Established ( |
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Previously Submitted | Input | Evaluates whether previous Case versions have been submitted. The system considers all previous Case versions that meet the following conditions:
This parameter is evaluated as "Yes" when the most recent Transmission that meets these conditions has Submit one last time set to "No". |
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Upgrade | Input |
Evaluates whether the current Case's seriousness, expectedness, and relatedness are upgraded from the previous Case version. The current Case’s Most Conservative Product/Assessment is compared against the previous Case version, based on one of the following priority lists: If your Admin has not enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:
If your Admin has enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:
If the current Case scenario is higher on the priority list than the previous Case version, this parameter is evaluated as "Yes". |
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Exclude MedDRA Query | Input |
Evaluates whether any Case Adverse Event matches a term defined within a MedDRA Query (SMQ/CMQ). If there is a match, a Transmission is not generated.
Any value entered for this parameter must correspond to an active |
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Include MedDRA Query | Input |
Evaluates whether at least one Case Adverse Event matches a term defined within a MedDRA Query (SMQ/CMQ). If there is a match, a Transmission is generated.
Any value entered for this parameter must correspond to an active |
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Reporting Scenario | N/A | Evaluates the reporting rule for potential cross reporting scenarios, if listed in this parameter. If this parameter is left blank, the system evaluates the Case for general reporting only. To use cross reporting, specify one or more cross reporting scenarios. Specify “General Reporting” along with cross reporting scenarios if the rule should general reporting too. This parameter accepts the following options:
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Product | Input | Evaluates whether a Case contains a specific Product. This parameter accepts a comma-separated list of active Product ( General Reporting: This parameter evaluates as "True" when a Case contains a Case Product with a matching API Name and a Drug Role of "Suspect". Cross Reporting: If Substitute Product/Study for Cross Reporting1 is enabled, then for X→M cross reporting scenarios, this parameter evaluates as "True" when the provided Product’s Registration is evaluated for cross reporting. If Substitute Product/Study for Cross Reporting is not enabled, this parameter is evaluated as for General Reporting above. |
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Study | Input | Evaluates whether a Case is associated with a specific Study.
This parameter accepts a comma-separated list of active Study API Names. General Reporting: This parameter evaluates as "True" when the Study ( Cross Reporting: If Substitute Product/Study for Cross Reporting1 is enabled, then for X→I cross reporting scenarios, this parameter evaluates as "True" when the provided Clinical Trial Study’s Registration is evaluated for cross reporting. If Substitute Product/Study for Cross Reporting is not enabled, this parameter is evaluated as for General Reporting above. |
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Identifiable Patient Definition | Input | Evaluates whether the Case has an identifiable patient. The following list describes how the system evaluates this parameter, depending on the value specified for a reporting rule set:
Note This parameter is only supported at the rule set level. |
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Local Expedited Criteria | Output | Controls the Local Expedited Criteria field on the Transmission. This parameter accepts the following values:
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Due in Days | Output | The Transmission due date, in days. The earliest Transmission due date is also populated in the Case Due Date field. For PMDA transmissions, see the following considerations:
This parameter accepts a positive whole number value. |
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Mask PII | Output | Evaluates whether the Case requires Personal Identifiable Information (PII) masking for Submissions. The following list describes how the system evaluates this parameter, depending on the value specified for a reporting rule:
Note This parameter only applies to Submissions. Distributions snapshot masking options from the Reporting Family. |
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Exceptions to PII Masking | Output | Evaluates whether the Case requires exceptions to PII masking for Submissions. This parameter is only evaluated if the Mask PII parameter is in use. This parameter accepts a comma-separated list of any of the following picklist values: blank_fields__v, parent_sex__v, patient_sex__v If a reporting rule specifies this parameter, the Exceptions to Patient Content Protection ( Note This parameter only applies to Submissions. Distributions snapshot masking options from the Reporting Family. |
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Transmission Profile Override | Output |
If a reporting rule specifies this parameter and the rule executes resulting in a Submission/Distribution, the Transmission record will have the Transmission Profile populated from the value in the rule parameter. This value will override any defaults selected on Product/Study Registrations or any defaulting logic based on the type of the products selected in the Case.
The parameter accepts the API Name of the appropriate Transmission Profile.
The value entered must correspond to an active |
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1. The Substitute Product/Study for Cross Reporting setting is located under Business Admin > Settings > ICSR Settings. |