Create PSUR and CIOMS II Line Listing Reports

Learn how to set up PSUR tabulations and CIOMS II line listings

Sections in This Article

About PSUR 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.

Note See Create CIOMS II Reports if you need to create a standalone CIOMS II report. The CIOMS II standalone report supports masking and can optionally include additional information beyond that required by regulations.

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

Tip An administrator can configure custom PSUR report templates for your organization.

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 administrator 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.
  • An administrator 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.

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.

    Note If you do not see PSUR as an option, an administrator 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. The system 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.

Note The Reporting Family object type should be Product Family.

To learn more, see Configure Aggregate Reporting Families.
Organization This field is automatically populated with the Organization on the selected Reporting Family.
Data Period Start (Required)

Enter the start date for the reporting period.

The system uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Cases 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 the system filter Cases within the specified date range, select an option:

  • Case Receipt Date / New Info Date (Default): 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 not specified, the Case Receipt Date/New Info Date are used by default. Depending on when your vault was originally deployed, an administrator may need to add this field to appear on the page layout.

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. Note that while Superseded is not listed as an option, the Closed state includes the Superseded state. Only system-provided states in the Case Processing Lifecycle are supported.

Note For Cases that have been nullified, ensure to change the Case Lifecycle State to a state that is not listed in the States to Include field. For example, if a nullified Case remains in the Closed state, the system will still consider the Case in aggregate reports.

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 and CIOMS II 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 Active Range for Expectedness in Aggregate Reports.

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, the system marks each unexpected adverse event with an asterisk (*).

To identify unexpected events, an administrator 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.

Expectedness in Aggregate Reports provides more information.

Note If an active start date is defined for the term on the datasheet, the system considers the Active Range for Expectedness. This behavior always applies to PSUR, regardless of the Indicate Unexpected Term setting.

PSUR Table Generation Data Mapping

Vault Safety populates aggregate report tables using Cases within the reporting period specified on the PSUR, and the reporting family members configured on the associated Reporting Family.

Tip For blinded studies, the system populates blinded product information as Blinded in the generated tables.

The following sections describe how Vault Safety generates PSUR tabulations:

CIOMS II Interval Line Listing of Adverse Drug Reactions

Table Constraints

The system 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)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • 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):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. Otherwise, the New Info Date is used:
        case_version__v.new_info_date__v
  • Suspect or Interacting 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) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • 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 Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age value and unit
    The system 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, the system populates the most serious outcome.

case_adverse_event__v.event_outcomes__v.name__v
			
where seriousness__v ≠ blank
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.

Table Constraints

The system 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 or Interacting 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) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • 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)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • 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 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):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. 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 include Spontaneous (Literature).
    case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
                                
    AND 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, the system 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. This does include the Study (Literature) 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)
    AND 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, the system 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, the system 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 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 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, the system 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

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

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.

The system 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, the system 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

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.

Table Constraints

The system 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 or Interacting 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) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • 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):
      1. If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used:
        case_version__v.receipt_date__v
      2. 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)

      Note You cannot select these states in the States to Include field. These states are always omitted.

    • 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 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. This does include the Study (Literature) 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)
AND 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 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 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

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

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.

The system 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, the system 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, the system 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

The PSUR line listings contain a log of each Case included in the line listings.


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