Create PBRER Aggregate Reports

Learn how to set up PBRER aggregate reports and generate PBRER report tables.

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About PBRER Reports

Vault Safety provides Periodic Benefit-Risk Evaluation Report (PBRER) authoring and table generation capabilities. The Vault Safety PBRER report adheres to the ICH E2C (R2) and GvP Module VII regulatory guidelines.

The following table summarizes the PBRER tabulations that Vault Safety generates:

Tabulation Generated by Default? Masking Support?
Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources Yes No
Cumulative Tabulation of Serious Adverse Events (from Clinical Trials) Yes Yes
Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) No Yes

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

Prerequisites

Consider the following prerequisites before you generate aggregate report 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 already configured the Reporting Family with the Products and Studies to include in the report.
  • To generate table data from Study-type Cases, an administrator must have configured the appropriate Study Products.

Create a PBRER Aggregate Report

Create a PBRER Aggregate Report and specify the report settings.

Add a PBRER

  1. In the Vault primary navigation bar, select Aggregate Reports > PBRER, and then select Create.
  2. In the Create Aggregate Report window, under Select Aggregate Report Type, select PBRER.
  3. Complete the fields on the Create PBRER page.
  4. Save the record.

Result

The Aggregate Report record enters the Pending state. The system assigns a task to users in the Safety Writer role to review the report details.

PBRER Fields

You can specify the following fields for a PBRER 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 If the latest Case version within the aggregate reporting period is in the Nullified or Voided state or in a lifecycle state assigned to the Deleted state type, the Case is excluded from the aggregate report.
Documents to Generate You can select which documents to generate.
The following options are available:
  • Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions from Clinical Trials

If you don't specify this field, by default the system generates the following documents:

  • Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources
  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials

By default, the documents are unmasked unless you select the Generate Masked Documents option. Depending on when your Vault was originally deployed, an administrator may need to add this field to appear on the page layout.
Generate Masked Documents

Select this option to generate a masked copy of the following tables for masked distributions, depending on the tables selected in the Documents to Generate field:

  • Cumulative Tabulation of Serious Adverse Events from Clinical Trials
  • Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)

Depending on when your Vault was originally deployed, an administrator may need to add this field to appear on the page layout.

To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR).
Indicate Unexpected Term

Select Yes to display an asterisk beside each unexpected adverse event term in the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked).
Datasheet

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

For DSUR and PBRER, the system always uses Use Approved Version at the beginning of the reporting period, including when this field is left blank. This setting means that the aggregate report Start 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 PBRER 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 PBRER report tables.

Mark Unexpected Terms in PBRER Reports

You can set the Indicate Unexpected Term on a PBRER so that when the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked) report is 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 Study or investigational Study Product added to the PBRER 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 PBRER Start Date must be within a term’s active range to be considered expected.

Active Range for Expectedness in Aggregate Reports provides more information.

PBRER Table Generation Data Mapping

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

The following sections describe how Vault Safety generates PBRER tabulations:

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

Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources

The following image map shows how Vault Safety generates the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources table.

Table Constraints

The system filters Cases to include in the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources 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 Product in Reporting Family
    A 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
  • 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 ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__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 PBRER.

    case_version__v.state__v CONTAINS pbrer__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, including regulatory authority and literature Cases are listed in this category when the Case Report Type is set to one of the following:
  • Spontaneous
  • Literature (Spontaneous)
  • Other
  • Not Available
case_version__v.report_type__v = 1, 3, 4 
{Spontaneous | Literature (Spontaneous) | Other | Not available}
2 Non-interventional Cases are listed in this category when they match one of the following scenarios:
Scenario Report Type Study Type Causality Established
1
  • Individual Patient Use
  • Other Study
  • A custom Study Type where the E2B Code is not set to 1 (Clinical Trial)
  • Yes
  • Blank
2
  • Literature (Study)
  • A custom Report Type with both of the following:
    1. The E2B Code field set to 2
    2. The Literature field set to Yes
  • Yes
  • Blank
 
COUNT IF
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
                    
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v ≠ 1)
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank
OR
(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 = Yes
                    
AND case_version__v.study_product_reason__v = blank)
                
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank
3 Serious Number of adverse events with a value entered in the Case Adverse Event Seriousness field. 
case_adverse_event__v.seriousness__v ≠ EMPTY
4 Non-Serious Number of adverse events with an empty Case Adverse Event Seriousness field. 
case_adverse_event__v.serious__v = EMPTY
5 SOC The MedDRA System Organ Class (SOC) for the adverse event. 
event_meddra__v.soc_term__v
6 Preferred Term The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC. 
case_adverse_event__v.event_meddra__v.pt_term__v

Case Adverse Events must have an associated Case Assessment to be listed in this report.

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 Interval

Number of adverse events with a Case date 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 ≥ pbrer__v.data_period_start__v AND

            DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__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 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
8 Cumulative

Number of adverse events with a Case date within the aggregate report cumulative reporting period (up to the Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__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 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
9 Total Spontaneous The total number of all adverse events within the "Spontaneous, including regulatory authority and literature" category, including both serious and non-serious, within the cumulative reporting period.

The Cases contained in the report are listed in a separate table:

Case Listings Table

Cumulative Tabulation of Serious Adverse Events From Clinical Trials

The system generates the Cumulative Tabulation of Serious Adverse Events From Clinical Trials by default for PBRER Aggregate Reports.

Table Constraints

Note In order for a Case to be considered for the report, the Case (created from AER, Inbox Item or Imported Case) must have a Case Product set to Primary.

The system filters Cases to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials 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 Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1 
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
                            
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    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 ≠ Yes 
    AND case_version__v.study_product_reason__v = blank
  • 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 PBRER.

    case_version__v.state__v CONTAINS pbrer__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 ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__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.

  • Serious Case Adverse Event
    The Case must contain at least one Case Adverse Event with a value specified in the Seriousness field (not blank). 
    case_adverse_event__v.seriousness__v ≠ BLANK
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family 
      case_version__v.study__v CONTAINS
                
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member 
      case_version__v.study__v CONTAINS
                
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v

Note To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.

Table Mapping

The following table outlines how the system maps data to populate the Cumulative Tabulation of Serious Adverse Events From Clinical Trials:

Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the adverse event. 
case_adverse_event__v.event_meddra__v.soc_term__v
2 Preferred Term The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC. 
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.
3 Investigational Medicinal Product The total number of adverse events with suspect investigational products. 
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes 
                    
AND case_product__v.study_product__v ≠ Blank 
                    
AND case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational)
4 Blinded The total number of adverse events with suspect blinded products. 
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes 
                    
AND case_version__v.case_product__v.study_product__v == Blank
5 Active Comparator The total number of adverse events with suspect active comparators. 
COUNT IF 
                
case_version__v.case_product__v.primary__v == Yes 
                
AND case_product__v.study_product__v ≠ Blank 
                
AND case_product__v.study_product__v.study_product_role__v == active_comparitor__v
6 Placebo The total number of adverse events with suspect placebos. 
COUNT IF 
                    
case_version__v.case_product__v.primary__v == Yes 
                    
AND case_product__v.study_product__v ≠ Blank 
                    
AND case_product__v.study_product__v.study_product_role__v == placebo__v

The Cases contained in the report are listed in a separate table:

Case Listing Table

Interval Line Listings of Serious Adverse Reactions

For PBRER reports, this table is not generated by default. You can generate Interval Line Listings of Serious Adverse Reactions by selecting this table in the Documents to Generate field on the PBRER record.

Table Constraints

The system filters Cases to include in the Interval Line Listings of Serious Adverse 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
  • Study Member of Reporting Family
    The Study field links to a Study record that is either:
    1. A member of the Reporting Family 
      case_version__v.study__v CONTAINS
                
      reporting_family__v.reporting_family_member__v.study__v
    2. Contains a Study Product that matches a Product Reporting Family Member 
      case_version__v.study__v CONTAINS
                
      reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v
  • Case Report and Study Type
    To filter study cases, the system looks at the Case Report Type and Study Type fields. A Case is included when it matches one of the following scenarios:
    Scenario Report Type Study Type
    1 
    case_version_v.report_type__v.controlled_vocabulary__v.
    e2b_code__v = 2
                            
    AND case_version__v.study_product_reason__v.controlled_vocabulary__v.
    e2b_code__v = 1
    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 ≠ Yes 
    AND case_version__v.study_product_reason__v = blank
  • 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 ≥ pbrer__v.data_period_start__v AND
    
            DATE ≤ pbrer__v.data_period_end__v

    where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__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.

  • Serious Case Adverse Event
    The Case must contain at least one Case Adverse Event with a value specified in the Seriousness field (not blank). 
    case_adverse_event__v.seriousness__v ≠ BLANK
  • Causality Established is Yes or Blank on Any Case Assessment

    The Causality Established field must be either Yes or blank (unknown) on any Case Assessment to consider the Case.

    case_assessment_result.causality_established == (Yes OR Blank)

    A Case is excluded from this report if all serious Case Adverse Events are assessed as unrelated. That is, if all serious Case Adverse Events are linked with at least two Case Assessment Results with the Causality Established field set to No, where:

    • One Case Assessment Result is for the company ("Sponsor" or "MAH"). That is, the Source Type maps to E2B Code 2 or 4.
    • One other Case Assessment Result where the Source Type does not map to E2B Code 2 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 PBRER.

    case_version__v.state__v CONTAINS pbrer__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

The following table outlines how the system maps data to populate the Interval Line Listings of Serious Adverse Reactions:

Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the adverse event. 
case_adverse_event__v.event_meddra__v.soc_term__v
2 Trial Number [EudraCT#] For studies registered to a country in the European Union, values are mapped from the following fields:
  • Trial Number: Case > Study Number 
    case_version__v.study_number__v
  • EudraCT#: Case Study Registration > Registration Number 
    case_study_registration__v.registration_number_value
                        
    where country_value__v.agency__v = EMA
3 Case ID/ Subject # Values from the following fields:
  • Case ID: Case > UID 
    case_version__v.uid__v
  • Subject ID: The system first attempts to map a value from the Case > MRN - Investigation field, but if this field is blank then the value is mapped from the Case > Patient Initials field. 
    IF case_version__v.mrn_investigation_value__v = Blank 
                  
    SHOW case_version__v.patient_id_value__v 
                  
    ELSE SHOW case_version__v.mrn_investigation_value__v
4 Country, Gender, Age Values from the following fields:
  • Country: Case > Event Country 
    case_version__v.event_country__v.name__v
  • Gender: Case > Patient Gender 
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (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 Serious ADR(s)

The MedDRA Preferred Term for the serious adverse event.

case_adverse_event__v.event_meddra__v.pt_term__v
            
where seriousness__v != null

The primary adverse event is listed first.
6 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, per E2B guidelines. 
case_adverse_event__v.event_outcomes__v.name__v
         
where seriousness__v != null
7 Date of Onset, Time to Onset Values are mapped for the primary Case Adverse Event as follows:
  • Date of Onset: Case Adverse Event > Onset in the format (DD-MMM-YYYY) 
    case_adverse_event__v.onset_date__v 
                     
    where primary__v = Yes
  • Time to Onset: Case Assessment > First Dose Latency (number) and First Dose Latency (unit) 
    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 Suspect Drug The name of the primary Case Product.
If the product is blinded, the value is Blinded. To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case. 
IF [case_version__v.case_product__v.primary__v = Yes 
               
AND case_version__v.case_product__v.study_product__v = Blank] 
               
THEN "Blinded"
               
ELSE case_version__v.case_product__v.product_name__v
               
where primary__v = Yes
9 Daily Dose, Route, Formulation

If the primary Case Product is blinded, the value is Blinded.

IF (case_product__v.primary__v = Yes) 
AND (case_version__v.case_product__v.study_product__v = Blank) 
THEN "Blinded"

If the not blinded, values are mapped from the primary Case Product > Case Product Dosage as follows:

  • 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: 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.
10 Dates of Treatment, Treatment Duration Values are mapped from the primary Case Product > Case Product Dosage object 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)
11 Comments Any text entered in the Case Reporting Summary field. 
case_version__v.reporting_summary__v
Sample PADER Generation When Filtering by Receipt Date / New Info Date
Create PSUR and CIOMS II Line Listing Reports
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