# Create PSUR and CIOMS II Line Listing Reports Vault Safety provides Periodic Safety Update Report (PSUR) authoring and table generation capabilities, including CIOMS II line listings. The Vault Safety PSUR report adheres to the ICH E2C (R1) regulatory guideline.
The following table summarizes the PSUR tabulations that Vault Safety generates:
Tabulation Generated by Default? Masking Support?
CIOMS II Interval Line Listing of Adverse Drug Reactions Yes No
Summary Tabulation of Serious Unlisted Adverse Drug Reactions Yes No
Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions Yes No
## Prerequisites Consider the following prerequisites before you generate PSUR tables: * You must be assigned permissions to view and prepare aggregate reports. Typically, these permissions are reserved for the Safety Writer and Head of Safety roles. * An Admin must have enabled PSUR Tabulations and CIOMS II Line Listings * The Reporting Family with the Products, Studies, and Substances to include in the PSUR tabulations and CIOMS II line listings. * Depending on your Admin's configuration, Case Products with the Drug Role of Drug Not Administered may be included when generating PSUR and CIOMS II Line Listing reports. See Enable Extend Definition of Suspect to Drug Not Administered for more information. If your Vault is not configured to include Drug Not Administered, only Case Products with the Suspect or Interacting Drug Role are included. * An Admin must have configured each product's Core Datasheet with a list of expected adverse events for the reporting family product. Vault Safety uses Core Product Datasheets to classify adverse events as listed or unlisted in PSUR tabulations. * To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must enable the Criteria Page for Aggregate reports. ## Create a PSUR Aggregate Report Create a PSUR Aggregate Report and specify the report settings. ### Add a PSUR 1. In the Vault primary navigation bar, select **Aggregate Reports > PSUR**, and then select **Create**. If you do not see PSUR as an option, an Admin must update your Vault to enable PSUR. 2. In the **Create Aggregate Report** window, under **Select Aggregate Report Type**, select **PSUR**. 3. Complete the fields on the **Create PSUR** page. 4. Save the record. **Result** The PSUR record enters the Pending state. Vault assigns a task to users in the Safety Writer role to review the report details. #### PSUR Fields You can specify the following fields for a PSUR Aggregate Report:
Field Description
Product Family (Required)

Select the Reporting Family configured for aggregate reporting.

To learn more, see Configure Aggregate Reporting Families.
Organization Vault populates this field with the Organization on the selected Reporting Family.
Data Period Start (Required)

Enter the start date for the reporting period.

Vault uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Case By setting is within the reporting period.

Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date.

To learn more, see How Aggregate Reports Filter by Data Period.
Data Period End (Required)

Enter the end date for the reporting period.

To learn more, see How Aggregate Reports Filter by Data Period.
Filter Case By

To customize how Vault filters Cases within the specified date range, select an option:

  • Case Receipt Date / New Info Date: The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields.
  • Case Approval Date: The date when the Case moved into the Approved state. If the Case was revised for a non-significant follow-up, the most recent approval date is used.

If this field is blank, Vault uses the Case Receipt Date/New Info Date.
Include Criteria Page on Documents

Select the checkbox to add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report.

When selected, the criteria page summarizes the following:

  • Report Parameters (including, the Document Name and Organization)
  • Filter Parameters (for example, the Product Family, report period start and end date, and States to Include)
  • Output Parameters (for example, Indicate Unexpected Terms and any additional fields displayed)
  • Legend (for example, an asterisk (*) indicates an Unexpected Event)
States to Include (Required)

Select the states that Cases must be in to be included in the report.

By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Although Superseded is not listed as an option, it is included within the Closed state. Only system-provided states in the Case Processing lifecycle are supported.
Indicate Unexpected Term

Select Yes to display an asterisk beside each unexpected adverse event term in the CIOMS II Line Listings.
Datasheet

This field works alongside the Indicate Unexpected Term setting for evaluating approved terms in product datasheets.

You can specify the following options for PSUR reports:

  • Use Approved Version at the beginning of the reporting period: The aggregate report Start Date must be within a term's active range to be considered Expected. This option is used by default, including when this field is left blank.
  • Use Approved Version at the end of the reporting period: The aggregate report End Date must be within a term's active range to be considered Expected.
To learn more, see Manage Datasheets and Auto-Expectedness.
### Generate PSUR Tabulations Review and verify the report settings. Once you have confirmed the report details are correct, use the Generate Aggregate Report Tabulations action to generate PSUR report tables. ## Mark Unexpected Terms in PSUR Reports You can set the **Indicate Unexpected Term** on a PSUR so that when the CIOMS II Line Listings are generated, Vault marks each unexpected adverse event with an asterisk (*). To identify unexpected events, an Admin must have configured the Core Datasheet for the products in the PSUR Reporting Family. The Datasheet can specify the Active Date Start, and optionally an Active Date End, which indicates when a term is approved as expected for the product. If configured, The PSUR Start Date must be within a term's active range to be considered expected. For more information about how to define an active range for expectedness in aggregate reports, see Manage Datasheets and Auto-Expectedness.
## PSUR Table Generation Data Mapping Vault Safety populates aggregate report tables using Cases within the reporting period specified on the [PSUR][1], and the reporting family members configured on the associated Reporting Family.
The following sections describe how Vault Safety generates PSUR tabulations: * [CIOMS II Interval Line Listing of Adverse Drug Reactions][2] * [Summary Tabulation of Serious Unlisted Adverse Drug Reactions][3] * [Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions][4] ### CIOMS II Interval Line Listing of Adverse Drug Reactions Interval Line Listing of Adverse Drug Reactions #### Table Constraints Vault filters Cases to include in the CIOMS II Interval Line Listing of Adverse Drug Reactions using the following constraints: ##### Case Not Suppressed The Case Suppress Submission field must be set to No or blank (not suppressed).
`case_version__v.suppress_submission__v ≠ Yes` ##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PSUR. `case_version__v.state__v CONTAINS psur__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)
* If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted. * When evaluating the **States to Include** field, the system evaluates Cases in the Superseded (`superseded_state__v`) state as Closed (`closed_state__v`). ##### Case Date in Interval Reporting Period The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information. DATE ≥ psur__v.data_period_start__v AND
DATE ≤ psur__v.data_period_end__v where _DATE_ depends on the option selected in the PSUR **Filter Cases By** (`psur__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` ##### Suspect, Interacting, or Drug Not Administered Case Product or Substance in Reporting Family A Case Product must meet both of the following conditions: * The Case Product must be a member of the Reporting Family `case_version__vr.case_product__v.product__v IN`
`aggregate_report_family__vr.aggregate_report_family_join__vr.products__v` OR
The Case Product must have a Product Substance that is a member of the Reporting Family `reporting_family_v.substance__v.substance_v ≠ BLANK`
`AND reporting_family_v.substance__v.substance_v =`
`case_product__v.product__v.product_substance__v` * The Drug Role field must be set to Suspect (E2B Code=1), Interacting (E2B Code=3), or Drug Not Administered (E2B Code=4) case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4
##### Case Report Type, Seriousness, Expectedness, and Causality The Case must match one of the following scenarios:
Scenario Report Type Seriousness Expectedness Causality Established
1 Serious (not blank) Any Any
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
AND case_version_v.seriousness__v ≠ blank
2 Blank (Non-Serious) Unexpected Any
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
AND case_version_v.seriousness__v = blank
AND case_version_v.expected__v = false
3 Serious (not blank) Any For any primary Case Assessment:
  • Yes
  • Unknown
  • Blank
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version_v.seriousness__v ≠ blank
AND case_assessment__v.case_assessment_result__v.causality_established__v =
Yes OR Null OR Unknown
WHERE case_assessment__v.case_product__v.primary__v = True
4 Serious (not blank) Any Any
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
AND case_version_v.seriousness__v ≠ blank
5 Blank (Non-Serious) Unexpected Any
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
AND case_version_v.seriousness__v = blank
AND case_version_v.expected__v = false
#### Table Mapping
Number Name Description
1 MAH Case Reference Number The value from the Case UID field.
case_version__v.uid__v
2 Country of Event The value from the Case Event Country field.
case_version__v.event_country__vr.name__v
3 Source The value selected in the Case Report Type field.
case_version_v.report_type__v
4 Sex
Age		 Values from the following fields:
  • Sex: Case > Patient Sex
    case_version__v.gender_value__v.name__v
  • Age: Case > Age value and unit
    Vault automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v)
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
5 Daily Dose, Route, Formation of Suspect Drug The following information is listed:
  • Daily Dose: Values are mapped from the following fields:
    1. Dose (number) and Dose (unit)
      case_product__v.case_product_dosage__v.dose_number__v
      AND dose_unit__v
    2. Frequency (number) and Frequency (unit)
      case_product__v.case_product_dosage__v.frequency_number__v
      AND frequency_unit__v
  • Route: Patient RoA Text
    case_product__v.case_product_dosage__v.patient_adminroute_text__v
  • Formulation of Suspect Product: Dose Form Text
    case_product__v.case_product_dosage__v.dose_form_text__v

If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.
6 Date of Onset The date entered in the Date of Onset field on the primary Case Adverse Event in the format DD-MM-YYYY.
case_adverse_event__v.onset_date__v
where primary__v = Yes
7 Time to Onset The value from the First Dose Latency on the primary Case Adverse Event.
case_assessment__v.first_dose_interval_number__v
case_assessment__v.first_dose_interval_unit__v
where case_assessment_v.case_product__v.primary__v = Yes
AND case_assessment_v.case_adverse_event__v.primary__v = Yes
8 Dates of Treatment
Treatment Duration		 Values are mapped from primary Case Product Dosages as follows:
  • Dates of Treatment: First Administration to Last Administration in the format (DD-MMM-YYYY)
    (case_product__v.case_product_dosage__v.firstadmin_idate__v)
    to (case_product__v.case_product_dosage__v.lastadmin_idate__v)
  • Treatment Duration: Duration (number) and Duration (unit)
    (case_product__v.case_product_dosage__v.duration_number__v)
    (case_product__v.case_product_dosage__v.duration_unit__v)
9 Description of Reaction Reported The list of adverse events, including both the reported term and MedDRA preferred term from each Case Adverse Event.
  • Reported:
    case_adverse_event__vr.event_reported__v
  • MedDRA:
    case_adverse_event__vr.event_meddra__vr.pt_term__v

Data from the primary Case Adverse Event is listed first, followed by other Case Adverse Events ordered by rank.
10 Outcome

The value selected in the Case Adverse Event Outcome field.

If there are multiple Case Adverse Event records on a Case, Vault displays the outcome of the primary Adverse Event (normally the most serious Adverse Event on the Case).

case_adverse_event__v.event_outcomes__v.name__v
where case_adverse_event__v.primary__v = Yes
11 Comments Any text entered in the Case Reporting Summary field. You can use this field to highlight causality information.
case_version__v.reporting_summary__v
### Summary Tabulation of Serious Unlisted Adverse Drug Reactions The following image map shows how Vault Safety generates the PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions table. Number of Adverse product Reactions by Term from Postmarketing Sources Table
#### Table Constraints Vault filters Cases to include in the Summary Tabulation of Serious Unlisted Adverse Drug Reactions using the following constraints: ##### Case Not Suppressed The Case Suppress Submission field must be set to No or blank (not suppressed).
`case_version__v.suppress_submission__v ≠ Yes` ##### Suspect, Interacting, or Drug Not Administered Case Product or Substance in Reporting Family A Case Product must meet both of the following conditions: * The Case Product must be a member of the Reporting Family `case_version__vr.case_product__v.product__v IN`
`aggregate_report_family__vr.aggregate_report_family_join__vr.products__v` OR
The Case Product must have a Product Substance that is a member of the Reporting Family `reporting_family_v.substance__v.substance_v ≠ BLANK`
`AND reporting_family_v.substance__v.substance_v =`
`case_product__v.product__v.product_substance__v` * The Drug Role field must be set to Suspect (E2B Code=1), Interacting (E2B Code=3), or Drug Not Administered (E2B Code=4) case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4
##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PSUR. `case_version__v.state__v CONTAINS psur__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)
* If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted. * When evaluating the **States to Include** field, the system evaluates Cases in the Superseded (`superseded_state__v`) state as Closed (`closed_state__v`). ##### Case Date in Cumulative Reporting Period The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information. DATE ≤ psur__v.data_period_end__v where `DATE` depends on the option selected in the PSUR **Filter Case By** (`psur__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed. #### Table Mapping
Number Name Description
1 Spontaneous
Serious - Unlisted
Sub-total		 Number of adverse events that meet the following criteria:
  • Spontaneous: Case Report Type is set to Spontaneous. This does not include Spontaneous (Literature). case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
    AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = (No or Blank)
  • Serious: A value selected in the Case Adverse Event > Seriousness field.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlisted: The MedDRA Preferred Term for the adverse event is not listed on the Core Datasheet for the primary Case Product within the reporting period.

    If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

    case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
    DOES NOT CONTAIN case_adverse_event__vr.event_meddra__v
2 Clinical Studies
Serious - Unlisted
Sub-total		 Number of adverse events that meet the following criteria:
  • Clinical Trials: Case Report Type is set to Study and the Study Type is set to Clinical Trial or is blank or does not contain a valid E2B Code. This does not include the Literature (Study) Report Type.
    case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2 (Study)
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 1 (Clinical Trial) or Blank or Invalid
    AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = (No or Blank)
  • Causality Established: The Case Assessment Result > Causality Established field is set to Yes or is blank (unknown).
    case_assessment_result.causality_established = (Yes OR Blank)
  • Serious: A value selected in the Case Adverse Event > Seriousness field.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlisted: The MedDRA Preferred Term for the adverse event is not listed on the Core Datasheet for the primary Case Product within the reporting period.

    If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

    case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
    DOES NOT CONTAIN case_adverse_event__vr.event_meddra__v
3 Literature
Serious - Unlisted
Sub-total		 Number of adverse events that meet the following criteria:
  • Literature: Case > Report Type set to one of the following:
    • Literature (Spontaneous)
    • Literature (Study)
    • A custom Report Type where the Literature field is set to Yes
    case_version_v.report_type__v.controlled_vocabulary__v.literature__v = Yes
  • Causality Established: The Case Assessment Result > Causality Established field is set to Yes or is blank (unknown). case_assessment_result.causality_established = (Yes OR Blank)
  • Serious: A value selected in the Case Adverse Event > Seriousness field.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlisted: The MedDRA Preferred Term for the adverse event is not listed on the Core Datasheet for the primary Case Product within the reporting period.

    If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

    case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
    DOES NOT CONTAIN case_adverse_event__vr.event_meddra__v
4 Other Sources
Serious - Unlisted
Sub-total		 Number of adverse events that meet the following criteria:
  • Other Sources: When either of the following conditions are met:
    Scenario Report Type Study Type
    1
    • Other
    • Not Available
    • A custom Report Type with:
      1. The E2B Code field set to 3 or 4
      2. The Literature field set to No or Blank
    		 N/A
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
    AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = No or Blank
    2
    • Study
    • A custom Report Type with:
      1. The E2B Code field set to 2
      2. The Literature field set to No or Blank
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
    AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = No or Blank
    AND case_version_v.study_type__v = 2 OR 3
  • Serious: A value selected in the Case Adverse Event > Seriousness field.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlisted: The MedDRA Preferred Term for the adverse event is not listed on the Core Datasheet for the primary Case Product within the reporting period.

    If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

    case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
    DOES NOT CONTAIN case_adverse_event__vr.event_meddra__v
5 SOC

The MedDRA System Organ Class (SOC) for the adverse event.

If the MedDRA term is not coded on the Case Adverse Event, the SOC is blank.

event_meddra__v.soc_term__v
6 Preferred Term The MedDRA Preferred Term for the adverse event.
case_adverse_event__v.event_meddra__v.pt_term__v
7 Listed on Core Datasheet? -
Event MedDRA.PT
Yes/No

Whether each adverse event is listed on the Core Datasheet for the primary Case Product within the reporting period.

Vault uses the MedDRA Preferred Term (PT) to determine whether an adverse event is listed.

If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

Yes IF
(case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
CONTAINS case_adverse_event__v.event_meddra__v)
ELSE No
8 Total The sum of the Spontaneous, Clinical Studies, Literature, and Other Sources occurrences for each SOC and Preferred Term.
9 Total The total number of Serious Unlisted Adverse Drug Reaction occurrences for each of the Spontaneous, Clinical Studies, Literature, and Other Sources categories.
### Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions The following image map shows how Vault Safety generates the PSUR Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions table. Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions
#### Table Constraints Vault filters Cases to include in the Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions using the following constraints: ##### Case Not Suppressed The Case Suppress Submission field must be set to No or blank (not suppressed).
`case_version__v.suppress_submission__v ≠ Yes` ##### Suspect, Interacting, or Drug Not Administered Case Product or Substance in Reporting Family A Case Product must meet both of the following conditions: * The Case Product must be a member of the Reporting Family `case_version__vr.case_product__v.product__v IN`
`aggregate_report_family__vr.aggregate_report_family_join__vr.products__v` OR
The Case Product must have a Product Substance that is a member of the Reporting Family `reporting_family_v.substance__v.substance_v ≠ BLANK`
`AND reporting_family_v.substance__v.substance_v =`
`case_product__v.product__v.product_substance__v` * The Drug Role field must be set to Suspect (E2B Code=1), Interacting (E2B Code=3), or Drug Not Administered (E2B Code=4) case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4
##### Case Date in Interval Reporting Period The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information. DATE ≥ psur__v.data_period_start__v AND
DATE ≤ psur__v.data_period_end__v where _DATE_ depends on the option selected in the PSUR **Filter Cases By** (`psur__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed. ##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PSUR. `case_version__v.state__v CONTAINS psur__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)
* If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted. * When evaluating the **States to Include** field, the system evaluates Cases in the Superseded (`superseded_state__v`) state as Closed (`closed_state__v`). #### Table Mapping
Number Name Description
1 Spontaneous Adverse events with the Case Report Type set to Spontaneous.
case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = (No or Blank)
2 Clinical Studies Adverse events with the Case Report Type set to Study and the Study Type is set to Clinical Trial or is blank or does not contain a valid E2B Code. This does not include the Literature (Study) Report Type.
case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2 (Study)
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 1 (Clinical Trial) or Blank or Invalid
AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = (No or Blank)
3 Literature Number of adverse events with the Case Report Type set to one of the following:
  • Literature (Spontaneous)
  • Literature (Study)
  • A custom Report Type where the Literature field is set to Yes
    case_version_v.report_type__v.controlled_vocabulary__v.literature__v = Yes
4 Other An adverse event is counted when either of the following conditions are met:
Scenario Report Type Study Type
1
  • Other
  • Not Available
  • A custom Report Type with:
    1. The E2B Code field set to 3 or 4
    2. The Literature field set to No or Blank
 N/A
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = No or Blank
2
  • Study
  • A custom Report Type with:
    1. The E2B Code field set to 2
    2. The Literature field set to No or Blank
case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version__v.report_type__v.controlled_vocabulary__v.literature__v = No or Blank
AND case_version_v.study_type__v = 2 OR 3
5 SOC

The MedDRA System Organ Class (SOC) for the adverse event.

If the MedDRA term is not coded on the Case Adverse Event, the SOC is blank.

event_meddra__v.soc_term__v
6 Preferred Term The MedDRA Preferred Term for the adverse event.
case_adverse_event__v.event_meddra__v.pt_term__v
7 Listed on Core Datasheet? -
Event MedDRA.PT
Yes/No

Whether each adverse event is listed on the Core Datasheet for the primary Case Product.

Vault uses the MedDRA Preferred Term (PT) to determine whether an adverse event is listed.

If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

Yes IF
(case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
CONTAINS case_adverse_event__v.event_meddra__v)
ELSE No
8 Serious - listed
Sub-total		 Number of adverse events that meet the following criteria:
  • Serious: A value is selected in the Case Adverse Event > Seriousness field.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Listed: The adverse event is listed on the Core Datasheet for the primary Case Product.

    If an active start date is defined for the term on the datasheet, Vault considers the Active Range for Expectedness.

    Yes IF
    (case_product__v.product__v.core_datasheet__v.meddra_criteria_datasheet__v
    CONTAINS case_adverse_event__v.event_meddra__v)
    ELSE No
9 Non-Serious Number of adverse events that do not have a value selected in the Case Adverse Event > Seriousness field.
case_adverse_event__v.seriousness__v = EMPTY
10 Total The sum of the Spontaneous, Clinical Studies, Literature, and Other Sources occurrences (both Serious - listed and Non-Serious) for each SOC and Preferred Term.
11 Total

For each of the Spontaneous, Clinical Studies, Literature, and Other Sources categories:

  • The total number of Serious - listed Adverse Drug Reaction occurrences
  • The total number of Non-Serious Adverse Drug Reaction occurrences
With the **PSUR Summary Totals and Separate Log Files** feature enabled in your Vault, a separate log file lists the Cases included in the Summary Tabulation of Serious Unlisted Adverse Drug Reactions and Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions. The log file uses the **Aggregate Reports > Summary Tabulation > Log** document type. Without the **PSUR Summary Totals and Separate Log Files** feature enabled in your Vault, the Cases included in the Summary Tabulation of Serious Unlisted Adverse Drug Reactions and Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions are listed in a separate table as part of the report. [1]: #create-psur [2]: #cioms-ii-line-listing [3]: #summary-tabulation-serious-unlisted [4]: #summary-tabulation-serious-listed-and-non-serious