Create Workbench SAR Reports

Learn about SAR aggregate reports in Workbench and how to generate them.

About Workbench SARs

Safety Workbench provides Serious Adverse Reactions (SAR) authoring and table generation capabilities. Masked and unmasked versions of all reports can be generated.

The following table summarizes the SAR tabulations that Safety Workbench generates:

Tabulation Description
SAR Line Listing This report prints the Case listings for SAR occurrences that match report criteria.
SAR Tabulation by PT This report prints the Case listings for SAR occurrences that match report criteria, organized by the MedDRA Preferred Term (PT).
SAR Tabulation by SOC, PT This report prints the Case listings for SAR occurrences that match report criteria, organized by the MedDRA System Organ Class (SOC) and then by the Preferred Term (PT).
SUSAR Line Listing This report prints the Case listings for SUSAR (suspected unexpected serious adverse reaction) occurrences that match report criteria.

Prerequisites

Your Admin must configure Workbench SAR reports.

SAR Criteria

Vault uses the SAR Principal view to assess each Case. To qualify for the SAR report, each returned Case must meet the following criteria:

  • One (1) of the following are met:
    • Contains at least one (1) Product defined by the product filter in the SAR Principal view.
    • Contains at least one (1) Study defined by the study filter.
  • The Case Category derived field is Interventional.
  • Contains at least one (1) SAR. This is when at least one (1) event on the Case is serious and related to a Study Drug Role of IMP, Comparator, Placebo, or blank.

SUSAR Criteria

A SUSAR report provides a more specific subset of SAR data. To qualify for the SUSAR report, a Case must have at least one (1) Adverse Event that meets the following criteria:

  • Is unlisted: Vault does the following to determine listedness:
    1. Identifies the relevant datasheet for the Case by ensuring the values for the following fields match between the datasheet and the Case Adverse Event:
      • MedDRA Term
      • Active Start Date
      • Active End Date
    2. Identifies the Case as listed if at least one (1) MedDRA Term on the datasheet is expected. Vault identifies the Case as unlisted if all matching MedDRA Terms are unexpected.
  • Is serious: Vault identifies an event as serious when the Seriousness field on the Case Adverse Event record is populated.
  • Is related to the suspect Product: Vault identifies a Case Adverse Event as related to a Case Product when any Case Assessment Result for this pair has Causality Established set to Yes or blank.

Create a Workbench SAR Report

To create a Workbench SAR report:

  1. Navigate to Workbench > Ad-Hoc Reports.
  2. Select Create.
  3. Complete the following information:
    • Name: Enter a name for this report.
    • Workbench View: Select a SAR view from the drop-down or use the Advanced Search (binoculars-icon) icon to use filters and refine your search.
  4. Set up Workbench Report filters, layout, and advanced options (standard templates) as needed.
  5. Select Save.
  6. Run and download the SAR report.

Workbench SAR Table Generation Data Mapping

The following sections describe how Workbench generates SAR tabulations:

SAR Line Listing

The following images displays the Workbench SAR Line Listing: saf-workbench-sar-line-listing-table1 saf-workbench-sar-line-listing-table2

Number Name Description
1 Study ID
EUDRA CT
Primary SOC		 Vault maps these values from the following fields:
  • Study ID: Case Study > Study Number
    case_version__v.study_number__v
  • EUDRA CT: Case Study Registration > Registration Number
    case_study_registration__v.registration_number_value
    WHERE
    country_value__v.agency__v = EMA
  • Primary SOC: The MedDRA System Organ Class (SOC) for the primary Case Adverse Event
    event_meddra__v.soc_term__v
    WHERE
    event_meddra__v.rank__v = 1
2 Case Number Vault maps this value from the Case > Case Number field.
case_version__v.case_number__v
3 Country
Age
Gender		 Vault maps these values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Age: Case > Age and Age (unit)
    Vault 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)
  • Gender: Case > Patient Sex
    case_version__v.gender_value__v.name__v
4 Product Name/Formulation Vault maps these values from the following fields:
  • Product Name: Case Product > Product
    case_product__v.product_name__v
  • Formulation: Case Product Dosage > Dose Form
    case_product_dosage__v.dose_form_text__v
5 Daily Dose Vault maps these values from the following fields:
  • Case Product Dosage > Dose (number and unit)
    case_product_dosage__v.case_product_dosage__v.dose_number__v
    case_product_dosage__v.case_product_dosage__v.dose_unit_text__v
  • Case Product Dosage > Frequency (number and unit)
    case_product_dosage__v.frequency_number__v
    case_product_dosage__v.frequency_unit__v
6 Dates of Treatment Vault maps these values from the Case Product Dosage > First Admin Date to Case Product Dosage > Last Admin Date in the format (DD-MMM-YYYY).
case_product_dosage__v.firstadmin_normalized__v - case_product_dosage__v.lastadmin_normalized__v
7 Event Onset or Latency

Vault maps this value from the Case Adverse Event > Onset field.
case_adverse_event__v.onset_date__v

If the Onset field is blank, Vault maps this value from the Case Assessment > First Dose Latency (number and unit) field.
case_assessment__v.first_dose_interval_number__v
case_assessment__v.first_dose_interval_unit__v
8 Event PT (MedDRA) The MedDRA PT of the Case Adverse Event.
case_adverse_event__v.event_meddra__v.pt_term__v
9 Event Outcome Vault maps this value from the Case Adverse Event > Outcome field.
case_adverse_event__v.event_outcomes__v.name__v
10 Seriousness The level of impact the adverse event had on the patient. Vault maps these values from the Case Adverse Event > Seriousness field.
case_adverse_event__v.seriousness__v
11 Listedness

Whether the Case is listed or unlisted.

Vault sets the value to Listed if at least one (1) MedDRA Term on the datasheet is expected.

Vault sets the value to Unlisted if all matching MedDRA Terms are unexpected.
12 Reporter Causality
Company Causality		 The results of the Case Assessment for the Reporter and Company source type. Vault maps these values from the Case Assessment Result > Assessment Result field.
case_assessment__v.case_assessment_result__v.assessment_result__v

SAR Tabulation by PT

The following image displays the Workbench SAR Tabulation by PT: saf-workbench-sar-tabulation-by-pt-table

Number Name Description
1 Event PT The MedDRA PT of the Case Adverse Event.
case_adverse_event__v.event_meddra__v.pt_term__v
2 Event Count The total sum of adverse events for each MedDRA PT.
3 Case Count The total sum of Cases for each MedDRA PT.

SAR Tabulation by SOC, PT

The following image displays the Workbench SAR Tabulation by SOC, PT: saf-workbench-sar-tabulation-by-soc-pt-table

Number Name Description
1 Event SOC The MedDRA SOC of the Case Adverse Event.
case_adverse_event__v.event_meddra__v.soc_term__v
2 Event PT The MedDRA PT of the Case Adverse Event.
case_adverse_event__v.event_meddra__v.pt_term__v
3 Event Count The total sum of adverse events for each MedDRA PT.
4 Case Count The total sum of Cases for each MedDRA PT.

SUSAR Line Listing

The following images displays the Workbench SUSAR Line Listing: saf-workbench-susar-line-listing-table1 saf-workbench-susar-line-listing-table2

Number Name Description
1 Study ID
EUDRA CT
Primary SOC		 Vault maps these values from the following fields:
  • Study ID: Case Study > Study Number
    case_version__v.study_number__v
  • EUDRA CT: Case Study Registration > Registration Number
    case_study_registration__v.registration_number_value
    WHERE
    country_value__v.agency__v = EMA
  • Primary SOC: The MedDRA System Organ Class (SOC) for the primary Case Adverse Event
    event_meddra__v.soc_term__v
    WHERE
    event_meddra__v.rank__v = 1
2 Case Number Vault maps this value from the Case > Case Number field.
case_version__v.case_number__v
3 Country
Age
Gender		 Vault maps these values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Age: Case > Age and Age (unit)
    Vault 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)
  • Gender: Case > Patient Sex
    case_version__v.gender_value__v.name__v
4 Product Name/Formulation Vault maps these values from the following fields:
  • Product Name: Case Product > Product
    case_product__v.product_name__v
  • Formulation: Case Product Dosage > Dose Form
    case_product_dosage__v.dose_form_text__v
5 Daily Dose Vault maps these values from the following fields:
  • Case Product Dosage > Dose (number and unit)
    case_product_dosage__v.case_product_dosage__v.dose_number__v
    case_product_dosage__v.case_product_dosage__v.dose_unit_text__v
  • Case Product Dosage > Frequency (number and unit)
    case_product_dosage__v.frequency_number__v
    case_product_dosage__v.frequency_unit__v
6 Dates of Treatment Vault maps these values from the Case Product Dosage > First Admin Date to Case Product Dosage > Last Admin Date in the format (DD-MMM-YYYY).
case_product_dosage__v.firstadmin_normalized__v - case_product_dosage__v.lastadmin_normalized__v
7 Event Onset or Latency

Vault maps this value from the Case Adverse Event > Onset field.
case_adverse_event__v.onset_date__v

If the Onset field is blank, Vault maps this value from the Case Assessment > First Dose Latency (number and unit) field.
case_assessment__v.first_dose_interval_number__v
case_assessment__v.first_dose_interval_unit__v
8 Event PT (MedDRA) The MedDRA PT of the Case Adverse Event.
case_adverse_event__v.event_meddra__v.pt_term__v
9 Event Outcome Vault maps this value from the Case Adverse Event > Outcome field.
case_adverse_event__v.event_outcomes__v.name__v
10 Seriousness The level of impact the adverse event had on the patient. Vault maps these values from the Case Adverse Event > Seriousness field.
case_adverse_event__v.seriousness__v
11 Listedness

Whether the Case is listed or unlisted.

Vault sets the value to Listed if at least one (1) MedDRA Term on the datasheet is expected.

Vault sets the value to Unlisted if all matching MedDRA Terms are unexpected.
12 Reporter Causality
Company Causality		 The results of the Case Assessment for the Reporter and Company source type. Vault maps these values from the Case Assessment Result > Assessment Result field.
case_assessment__v.case_assessment_result__v.assessment_result__v