Reporting Rule Parameter Reference

Learn about the rule parameters supported for Safety Rules.

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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:

Sample FDA Safety Rule
Sample FDA 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.

Parameter Type (Input/Output) Description
Report Type Input

The Case's Report Type (report_type__v) classification.

The value must be a report type that is configured in the Controlled Vocabulary and has an E2B Code.

Study Type Input

The Case's Study Type (product_usage_reason__v) classification.

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.
Serious Input

Whether the case meets seriousness criteria.

The system evaluates this parameter using the method specified on the rule set:

  • Primary (default): Whether a value is populated in the Case Seriousness (seriousness__v) field.
  • Most Conservative: Whether a value is populated in the Seriousness (seriousness__v) field on the Case Adverse Event associated with the most conservative Case Product and Assessment.
Life Threatening Input

Whether the case meets life-threatening seriousness criteria.

The system evaluates this parameter using the method specified on the rule set:

  • Primary (default): Whether "Life threatening" is populated in the Case Seriousness (seriousness__v) field.
  • Most Conservative: Whether "Life threatening" is populated in the Seriousness (seriousness__v) field on the Case Adverse Event associated with the most conservative Case Product and Assessment.
Fatal Input

Whether the case meets fatal seriousness criteria.

The system evaluates this parameter using the method specified on the rule set:

  • Primary (default): Whether "Results in death" is populated in the Case Seriousness (seriousness__v) field.
  • Most Conservative: Whether "Results in death" is populated in the Seriousness (seriousness__v) field on the Case Adverse Event associated with the most conservative Case Product and Assessment.
Expected Input

Locates the relevant Case Assessment Expectedness records based on the evaluation method specified on the rule set:

  • Primary (default): The system evaluates the Expectedness records under the primary Case Assessment.
  • Most Conservative: The system evaluates the Expectedness records under the most conservative Case Assessment.

The system uses logic to evaluate the appropriate Expectedness records for this parameter. To see the detailed logic, click the button below:
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.
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:

  • Primary (default): Whether the Agency is assigned jurisdiction over the Event Country (event_country__v) selected on the primary Case Adverse Event.
  • Most Conservative: Whether the Agency is assigned jurisdiction over the Country (country_value__v) selected for the primary Reporter-type Case Contact.

You can view the countries in an agency's jurisdiction by going to the Agency-type Organization record in the Business Admin area.
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.
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:

  • Primary (default): The value from the Case Tags (case_tags__v) field on the Case.
  • Most Conservative: The value from the Assessment Tag (assessment_tag__v) field on the most conservative Case Assessment.

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.
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:

  • Primary (default): The system evaluates the primary Case Assessment.
  • Most Conservative: The system evaluates the most conservative Case Assessment. The system only considers Case Assessment Results with a matching Source Type to find the most conservative Case Assessment.

The system evaluates this parameter using the Controlled Vocabulary E2B Code corresponding to the Source Type (source_type__v) on a Case Assessment.

Device Report Type Input

The Case Device Report Type (device_report_type__v) classification. This parameter is used in FDA device reporting rules.

This parameter accepts "Public Health Risk" or "Malfunction Only" as acceptable values.

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:

  1. Fatal/Life Threatening/ Serious Unexpected Related (Fatal/LT SUSAR)
  2. Serious Unexpected Related (SUSAR)
  3. Serious Expected Related (SESAR)
  4. Non-Serious Unexpected Related (NSUR)
  5. Non-Serious Expected Related (NSER)
  6. Serious Unexpected Unrelated (SU)
  7. Serious Expected Unrelated (SE)
  8. Non-Serious Unexpected Unrelated (NSU)
  9. Non-Serious Expected Unrelated (NSE)

If your Admin has enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:

  1. Fatal/Life Threatening/ Serious Unexpected Related (Fatal/LT SUSAR)
  2. Serious Unexpected Related (SUSAR)
  3. Serious Unexpected Unrelated (SU)
  4. Serious Expected Related (SESAR)
  5. Serious Expected Unrelated (SE)
  6. Non-Serious Unexpected Related (NSUR)
  7. Non-Serious Unexpected Unrelated (NSU)
  8. Non-Serious Expected Related (NSER)
  9. Non-Serious Expected Unrelated (NSE)

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.
Transmission Reason Input and Output

This parameter is evaluated using the previous Transmissions to the same reporting destination and sets the Reason (reason__v) field on the Transmission, using the following logic:

  • Evaluates as Follow-up if either of the following conditions are met:
    • If a previous Case version has a Transmission to the same reporting destination in either of the following states:
      • Completed
      • E2B ACK Accepted
    • If a previous Case version is of the Imported Case object type and the Imported Case does not have Transmission to same reporting destination
  • In all other scenarios, evaluates as Initial
Registration Type Input

The Registration Type (registration_type__v) classification on the primary Case Product Registration for the most conservative Case Product. If a primary Case Product Registration does not exist, the system evaluates the Registration Type on the Product Registration with the earliest creation date within the agency's jurisdiction.

The value must be a registration type that is configured in the Controlled Vocabulary.

This parameter is used in PMDA reporting rules.
PMDA Reporting Category Input

The PMDA Reporting Category (pmda_reporting_category__v) classification on the primary Case Product Registration on a Japan Localized Case. The primary Case Product Registration is designated by a rank of 1 in the PMDA Rank field.

This parameter accepts a comma separated-list of the active values from within the PMDA Reporting Category Picklist.

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:

  1. If there is a primary Case Product Registration on the Japan Localized Case, evaluated as "Yes" when the PMDA Reporting Category (pmda_reporting_category__v) classification is "AA" or "AC". The primary Case Product Registration is designated by a rank of 1 in the PMDA Rank field.
  2. If there is not a primary Case Product Registration, the system evaluates the Case Adverse Event associated with the most conservative Case Assessment. Evaluated as "Yes" when the adverse event MedDRA Term is under the "Infections and Infestations" (10021881) MedDRA SOC.
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:

  • Primary (default): Evaluates Case Assessment Results under the primary Case Assessment.
  • Most Conservative: Evaluates Case Assessment Results under the most conservative Case Assessment.

This parameter is evaluated as "Related" when the relevant Case Assessment contains at least one Case Assessment Result with the Causality Established (causality_established__v) field set to "Yes" or blank.
Previously Submitted Input

Evaluates whether previous Case versions have been submitted. The system considers all previous Case versions that meet the following conditions:

  • Has a Transmission in the "E2B ACK Accepted" or "Completed" state for the same reporting destination.
  • The Downgrade reporting rule parameter was not evaluated as "Yes".

This parameter is evaluated as "Yes" when the most recent Transmission that meets these conditions has Submit one last time set to "No".
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:

  1. Fatal/Life Threatening/ Serious Unexpected Related (Fatal/LT SUSAR)
  2. Serious Unexpected Related (SUSAR)
  3. Serious Expected Related (SESAR)
  4. Non-Serious Unexpected Related (NSUR)
  5. Non-Serious Expected Related (NSER)
  6. Serious Unexpected Unrelated (SU)
  7. Serious Expected Unrelated (SE)
  8. Non-Serious Unexpected Unrelated (NSU)
  9. Non-Serious Expected Unrelated (NSE)

If your Admin has enabled the Prioritize Seriousness for MCP feature, the priority list is as follows:

  1. Fatal/Life Threatening/ Serious Unexpected Related (Fatal/LT SUSAR)
  2. Serious Unexpected Related (SUSAR)
  3. Serious Unexpected Unrelated (SU)
  4. Serious Expected Related (SESAR)
  5. Serious Expected Unrelated (SE)
  6. Non-Serious Unexpected Related (NSUR)
  7. Non-Serious Unexpected Unrelated (NSU)
  8. Non-Serious Expected Related (NSER)
  9. Non-Serious Expected Unrelated (NSE)

If the current Case scenario is higher on the priority list than the previous Case version, this parameter is evaluated as "Yes".
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 meddra_query__v.

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 meddra_query__v.

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:

  • Investigational to Marketing (same agency)
  • Investigational to Marketing (cross agency)
  • Investigational to Investigational (cross agency)
  • Marketing to Marketing (cross agency)
  • Marketing to Investigational (cross agency)
  • General Reporting

    Note You do not need to specify the general reporting scenario unless you are pairing it with additional cross reporting scenarios. The general reporting scenario is used by default if this parameter is empty.
Product Input

Evaluates whether a Case contains a specific Product.

This parameter accepts a comma-separated list of active Product (product__v) API Names.

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.
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 (study__v) selected on the Case has a matching API Name.

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.
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:

  • E2D: Evaluated as "True" when a patient is identified on a Case with an age, name, gender, or MRN. To see the list of fields the system evaluates to find an identifiable patient, click the button below:
  • E2D or Patient Known to Exist: Evaluated as "True" when the Patient Known to Exist (patient_known_to_exist__v) field or any of the above fields are populated on the Case.

Note This parameter is only supported at the rule set level.
Local Expedited Criteria Output

Controls the Local Expedited Criteria field on the Transmission. This parameter accepts the following values:

  • Yes: Populates "Yes"
  • No: Populates "No"
  • Same as Previous: If there is a previous version of the Case with a Transmission to the same agency in the "Completed" or "E2B ACK Accepted" state, copies the value from the previous Transmission.

    Note We recommend that you contact Veeva Managed Services if you receive an error when using the Same as Previous option.
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:

  • If there is a Previously Submitted version of a Case, the Transmission due date is calculated by adding the value of the Local Awareness Date on the Japan local Case and the Due in Days value.
  • If there is no Local Awareness Date, the Transmission due date is calculated by adding the New Info Date and the Due in Days value.
  • The Due in Days field value is also used to determine the Due in Days for PMDA downgrade reports. If the Due in Days field value in the previous Transmission record is deleted or not entered when the transmission record is manually generated, the system will use 15 days as default.
  • To avoid deleting or missing an entry in the Due in Days field, we recommend that an admin configures a validation rule for the “Due in Days" field to be mandatory.

This parameter accepts a positive whole number value.

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:

  • All: The Patient Content Protection (patient_content_protection__v) field is set to "Mask PII" on the Submission.
  • Foreign: If the AE in Jurisdiction parameter is evaluated as "No", then the Patient Content Protection (patient_content_protection__v) field is set to "Mask PII" on the Submission.

Note This parameter only applies to Submissions. Distributions snapshot masking options from the Reporting Family.
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 (exceptions_to_patient_content_protection__v) field is set to the specified values on the Submission.

Note This parameter only applies to Submissions. Distributions snapshot masking options from the Reporting Family.
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 transmission_profile__v.

1. The Substitute Product/Study for Cross Reporting setting is located under Business Admin > Settings > ICSR Settings.
Reporting Rule Sets
Cross Reporting
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