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
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. The system evaluates this parameter for Report Types with the same 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. The system evaluates this parameter for Study Types with the same E2B code.
Note If the Study Type value on the Case is left blank, this parameter is 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.
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:
Non-Study Cases:
The system first evaluates all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
If there are no Local Datasheets within the reporting jurisdiction, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
Study Cases:
The system first evaluates all Study Product Datasheets for Study Products in the Case using the following logic:
Expected:
If all Study Product Expectedness records are Expected.
Unexpected:
When one or more Study Product Expectedness records are Unexpected or blank.
If there are no Study Product Datasheets, the system performs the evaluation based on the Study Core Datasheet to set the Expected value.
For
Clinical Trial Study Cases
A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
only, Expectedness evaluation considers Adverse Event Onset Date, which must fall within the Datasheet term’s Active Start and End Dates to be considered Expected. Dates outside this range are considered Unexpected. If there is no Active End Date, the term is considered to be Expected to the present day. If there is no Active Start or End Date, the term is always considered Expected.
If the Adverse Event Onset Date is not available, the system uses the Case Receipt Date for the evaluation.
For
Postmarket Study Cases
A Case is categorized as a postmarket study case when it has a Study Report Type and a Study Type of "Individual Patient Use" or "Other Study".
only, if there is no Study Datasheet, the system then looks at all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
This step does not occur for Clinical Trial Study Cases.
Otherwise, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
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.
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 system finds the most conservative Case Product for a region using the following criteria:
For a non-clinical trial Case: Contains a Product Registration for a Country within the jurisdiction of the Agency being evaluated by the rule set.
For a clinical trial Case: Contains a Study Product for a Study registered for a Country within the jurisdiction of the Agency being evaluated by the rule set.
Contains a Drug Role set to Suspect or Interacting.
Is associated with the
most conservative Case Assessment
for the region.
If one or more Case Products for the region are not associated with a Case Assessment, the system queries all Case Products with Case Assessments to identify the most conservative product and assessment.
For cross reporting, the system considers only Case Products that are being cross reported to, rather than all Case Products.
Note If multiple Case Products match the above criteria, the system uses the product with the highest value in the Rank field.
Note Device constituents cannot be considered the most conservative product.
Most Conservative Assessment Criteria
The following table outlines how the system ranks Case Assessments using the above data in the Most Conservative Product Criteria section, from most to least conservative:
Summary
Seriousness
Expectedness
Relatedness
Ranking
Fatal/LT SUSAR
Fatal, or
Life Threatening1
Unexpected
Related
1 (Most Conservative)
SUSAR
Serious
Unexpected
Related
2
SU
Serious
Unexpected
Unrelated
3
SESAR
Serious
Expected
Related
4
SE
Serious
Expected
Unrelated
5
NSUR
Non-Serious
Unexpected
Related
6
NSU
Non-Serious
Unexpected
Unrelated
7
NSER
Non-Serious
Expected
Related
8
NSE
Non-Serious
Expected
Unrelated
9 (Least Conservative)
1. If a case contains both a Life Threatening SUSAR and a Fatal SUSAR, the tiebreaker for Most Conservative Assessment will be the Fatal SUSAR.
The system considers the most conservative Case Assessment for a region using the following data:
Seriousness:
The Seriousness of the Case Adverse Event associated with the Case Assessment.
Expectedness:
The Expectedness associated with the Case Assessment. Case Assessment Expectedness are automatically calculated using Datasheets.
The system uses logic to evaluate the appropriate Expectedness records for this parameter. To see the detailed logic, expand the section 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:
Non-Study Cases:
The system first evaluates all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
If there are no Local Datasheets within the reporting jurisdiction, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
Study Cases:
The system first evaluates all Study Product Datasheets for Study Products in the Case using the following logic:
Expected:
If all Study Product Expectedness records are Expected.
Unexpected:
When one or more Study Product Expectedness records are Unexpected or blank.
If there are no Study Product Datasheets, the system performs the evaluation based on the Study Core Datasheet to set the Expected value.
For
Clinical Trial Study Cases
A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
only, Expectedness evaluation considers Adverse Event Onset Date, which must fall within the Datasheet term’s Active Start and End Dates to be considered Expected. Dates outside this range are considered Unexpected. If there is no Active End Date, the term is considered to be Expected to the present day. If there is no Active Start or End Date, the term is always considered Expected.
If the Adverse Event Onset Date is not available, the system uses the Case Receipt Date for the evaluation.
For
Postmarket Study Cases
A Case is categorized as a postmarket study case when it has a Study Report Type and a Study Type of "Individual Patient Use" or "Other Study".
only, if there is no Study Datasheet, the system then looks at all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
This step does not occur for Clinical Trial Study Cases.
Otherwise, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
Relatedness:
The Causality Established field on Assessment Results under the Case Assessment. A product and event are considered Related when one or more Case Assessment Results have the Causality Established field set to Yes or Blank.
Note For rules that use the Assessment Source parameter, such as FDA SUSAR reporting rules, to evaluate relatedness, the system only considers Case Assessment Results with a matching Source Type to find the most conservative Case Assessment.
Note Assessments for device constituents cannot be considered the most conservative assessment.
The Upgrade/Downgrade Transmission State Evaluation feature controls the evaluation of this parameter, as shown in the table below.
Contact Veeva Support
if you require this feature to be made available in your Vault.
Upgrade / Downgrade Enhancements Feature
Downgrade Parameter Value
Parameter Evaluation Logic
Enabled
Yes
All of the following conditions must apply:
The Case is in the ACK Accepted or Completed Transmission Lifecycle state.
The Case was previously submitted to the same Destination and Transmission Profile.
The current Case Seriousness/Expectedness/Relatedness is lower on the priority list than the previous Case version submitted to the same Destination and Transmission Profile.
All Transmission States
All of the following conditions must apply:
The Case is in any Transmission Lifecycle state except Inactive or the Transmission Deleted state type.
The Case was previously submitted to the same Destination and Transmission Profile.
The current Case Seriousness/Expectedness/Relatedness is lower on the priority list than the previous Case version submitted to the same Destination and Transmission Profile.
No
The current Case Seriousness/Expectedness/Relatedness is equal to or higher on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
Not Enabled
Yes
The current Case Seriousness/Expectedness/Relatedness is lower on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
No
The current Case Seriousness/Expectedness/Relatedness is equal to or higher on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
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_cv__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 only.
PMDA Reporting Category
Input
The PMDA Reporting Category (pmda_reporting_category__v) classification on the Local Reporting Details section of a Japan Localized Case.
This parameter accepts a comma separated-list of the active values from within the PMDA Reporting Category picklist.
This parameter applies only when using PMDA ICSR Reporting Rule Set Version 1.0.
Infection
Input
Evaluates whether the Localized Case includes a Special Adverse Event (special_adverse_event__v) that is set to Infection.
This parameter is used in PMDA reporting rules and is evaluated only when the rule is run on Localized Cases.
Special Report Classification
Input
The Special Report Classification (special_report_classification__v) on the Case. The Case may be classified as a Safety Measure Report or a Research Report.
This parameter is used in PMDA reporting rules. Special Report Classification is an optional field.
If this parameter is set to “No”, the rule is evaluated when the Special Report Classification field is blank.
Previously Localized
Input
If this parameter is set to “Yes”, the rule evaluates whether a previous version of the Case has a Completed/ACK Accepted Submission to the same agency where the One Last Time (OLT) rule is not evaluated as “True”.
If this parameter is set to “All Transmission States”, the rule evaluates if a previous version of the Case has a Submission in any state (except Inactive or a Deleted state type) to the same agency where OLT is not evaluated as “True”.
Note The system cannot automatically set OLT to “True” on Local Reporting Detail-based Localized Submission records. This is a known limitation that will be addressed in a future release.
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 logic used by the system is based on whether the parameter is set to "Yes" or "All Transmission States" as follows:
Yes:
The system evaluates all previous Case versions with a Transmission in the "E2B ACK Accepted" or "Completed" state for the same reporting Destination and Transmission Profile.
The system then checks that the Downgrade reporting rule parameter was not evaluated as "Yes".
Finally, the system checks that the most recent Transmission that meets the first two conditions has Submit one last time set to "No".
All Transmission States:
The system evaluates all previous Case versions with a Transmission in any lifecycle state, except for Inactive or Deleted, for the same reporting Destination and Transmission Profile.
The system checks that the most recent Transmission that meets the above 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 system finds the most conservative Case Product for a region using the following criteria:
For a non-clinical trial Case: Contains a Product Registration for a Country within the jurisdiction of the Agency being evaluated by the rule set.
For a clinical trial Case: Contains a Study Product for a Study registered for a Country within the jurisdiction of the Agency being evaluated by the rule set.
Contains a Drug Role set to Suspect or Interacting.
Is associated with the
most conservative Case Assessment
for the region.
If one or more Case Products for the region are not associated with a Case Assessment, the system queries all Case Products with Case Assessments to identify the most conservative product and assessment.
For cross reporting, the system considers only Case Products that are being cross reported to, rather than all Case Products.
Note If multiple Case Products match the above criteria, the system uses the product with the highest value in the Rank field.
Note Device constituents cannot be considered the most conservative product.
Most Conservative Assessment Criteria
The following table outlines how the system ranks Case Assessments using the above data in the Most Conservative Product Criteria section, from most to least conservative:
Summary
Seriousness
Expectedness
Relatedness
Ranking
Fatal/LT SUSAR
Fatal, or
Life Threatening1
Unexpected
Related
1 (Most Conservative)
SUSAR
Serious
Unexpected
Related
2
SU
Serious
Unexpected
Unrelated
3
SESAR
Serious
Expected
Related
4
SE
Serious
Expected
Unrelated
5
NSUR
Non-Serious
Unexpected
Related
6
NSU
Non-Serious
Unexpected
Unrelated
7
NSER
Non-Serious
Expected
Related
8
NSE
Non-Serious
Expected
Unrelated
9 (Least Conservative)
1. If a case contains both a Life Threatening SUSAR and a Fatal SUSAR, the tiebreaker for Most Conservative Assessment will be the Fatal SUSAR.
The system considers the most conservative Case Assessment for a region using the following data:
Seriousness:
The Seriousness of the Case Adverse Event associated with the Case Assessment.
Expectedness:
The Expectedness associated with the Case Assessment. Case Assessment Expectedness are automatically calculated using Datasheets.
The system uses logic to evaluate the appropriate Expectedness records for this parameter. To see the detailed logic, expand the section 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:
Non-Study Cases:
The system first evaluates all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
If there are no Local Datasheets within the reporting jurisdiction, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
Study Cases:
The system first evaluates all Study Product Datasheets for Study Products in the Case using the following logic:
Expected:
If all Study Product Expectedness records are Expected.
Unexpected:
When one or more Study Product Expectedness records are Unexpected or blank.
If there are no Study Product Datasheets, the system performs the evaluation based on the Study Core Datasheet to set the Expected value.
For
Clinical Trial Study Cases
A Case is categorized as a clinical trial case when the Case Report Type is "Study" and the Study Type is "Clinical Trial" or unspecified (blank).
only, Expectedness evaluation considers Adverse Event Onset Date, which must fall within the Datasheet term’s Active Start and End Dates to be considered Expected. Dates outside this range are considered Unexpected. If there is no Active End Date, the term is considered to be Expected to the present day. If there is no Active Start or End Date, the term is always considered Expected.
If the Adverse Event Onset Date is not available, the system uses the Case Receipt Date for the evaluation.
For
Postmarket Study Cases
A Case is categorized as a postmarket study case when it has a Study Report Type and a Study Type of "Individual Patient Use" or "Other Study".
only, if there is no Study Datasheet, the system then looks at all Local Datasheets for countries in the jurisdiction of the agency using the following logic:
Expected:
If all local Expectedness records are Expected.
Unexpected:
When one or more local Expectedness records are Unexpected or blank.
This step does not occur for Clinical Trial Study Cases.
Otherwise, the Expected value corresponding to the Product's Core Datasheet is used.
If there are no Expectedness records, the system uses the value from the Expected field on the relevant Case Assessment.
Relatedness:
The Causality Established field on Assessment Results under the Case Assessment. A product and event are considered Related when one or more Case Assessment Results have the Causality Established field set to Yes or Blank.
Note For rules that use the Assessment Source parameter, such as FDA SUSAR reporting rules, to evaluate relatedness, the system only considers Case Assessment Results with a matching Source Type to find the most conservative Case Assessment.
Note Assessments for device constituents cannot be considered the most conservative assessment.
The Upgrade/Downgrade Transmission State Evaluation feature controls the evaluation of this parameter, as shown in the table below.
Contact Veeva Support
if you require this feature to be made available in your Vault.
Upgrade / Downgrade Enhancements Feature
Downgrade Parameter Value
Parameter Evaluation Logic
Enabled
Yes
All of the following conditions must apply:
The Case is in the ACK Accepted or Completed Transmission Lifecycle state.
The Case was previously submitted to the same Destination and Transmission Profile.
The current Case Seriousness/Expectedness/Relatedness is higher on the priority list than the previous Case version submitted to the same Destination and Transmission Profile.
All Transmission States
All of the following conditions must apply:
The Case is in any Transmission Lifecycle state except Inactive or the Transmission Deleted state type.
The Case was previously submitted to the same Destination and Transmission Profile.
The current Case Seriousness/Expectedness/Relatedness is higher on the priority list than the previous Case version submitted to the same Destination and Transmission Profile.
No
The current Case Seriousness/Expectedness/Relatedness is equal to or lower on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
Not Enabled
Yes
The current Case Seriousness/Expectedness/Relatedness is higher on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
No
The current Case Seriousness/Expectedness/Relatedness is equal to or lower on the priority list than that of the previous Case version submitted to the same Destination and Transmission Profile, regardless of Transmission Lifecycle state.
Exclude MedDRA Query
Input
Evaluates if all Case Adverse Events match with terms defined within a MedDRA Query (SMQ/CMQ). If all Case Adverse Events 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.
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.
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.
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.
Product Registration Type
Input
Evaluates whether a Case contains a Product of the specified Product Registration Type.
This parameter accepts a comma-separated list of active Product Type (product_type__v) names.
The acceptable Product Types include the following:
Drug (drug__v)
Biologic (biologic__v)
Device (device__v)
Vaccine (vaccine__v)
Combination Product (combination_product__v)
Cosmetic (cosmetic__v)
Nutritional (nutritional__v)
OTC Drug (otc_drug__v)
OTC Device (otc_device__v)
If your Vault contains custom Product Types, these can be added to the Product Registration Type parameter if required.
The rule will pass if the Case contains a Product with one of the specified Transmission Product Types within that jurisdiction of the agency destination being evaluated.
If this field is left blank, the rule will pass if the Case contains a Product with one of the following Product Types:
Drugs
Biologics
Vaccines
Combination Products
In addition, for Cross Reporting (X→M Scenarios), the parameter will evaluate the Transmission Product Type of the registration which is generating a cross reporting obligation.
Note For Cross Reporting (X→I Scenarios), the Product Registration Type parameter is not supported and so will always pass.
When evaluating a Distribution, Vault Safety obtains the Transmission Product Type as follows:
If the Distribution is based on a Product, the system uses the Transmission Product Type from within the Product Reporting Family Member.
If the Distribution is based on a Product Registration, the system uses the Transmission Product Type from the linked Registration within the Product Registration Reporting Family Member.
If the Distribution is based on a Study or Study Registration, the parameter is ignored.
1. The Substitute Product/Study for Cross Reporting setting is located under Admin > Settings > ICSR Settings.
