Create Workbench PADER Aggregate Reports

Case Not Suppressed

The Suppress Submission field on the Case must be set to No or blank (not suppressed).

case_version__v.suppress_submission__v ≠ Yes

Valid FDA Transmission in Reporting Period

Vault finds Cases submitted to the FDA within the reporting period. Cases must have an associated Transmission that meets the following conditions:

• The Transmission Destination is FDA.
  
  case_version__v.transmission__v.destination__v = fda__v
• The Transmission Date is within the interval reporting period specified in the Workbench PADER report set.
  
  transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range
• The Transmission is in the ACK Accepted or Completed lifecycle state.
  
  case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

The reports list only the latest version of the Case transmitted to the FDA within the reporting period.

Matching Product Registration on the Transmission

The Reportable Product Registration on the Transmission record matches that listed in the Aggregate Reporting Group.

case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v

Non-Matching Product Registration on the Transmission

The Reportable Product Registration on the Transmission record does not match that listed in the Aggregate Reporting Group.

case_version__v.transmission__v.reportable_product_registration__v.registration_number__v != aggregate_reporting_group__v.product_registration__v.registration_number__v

Eligible Drug Roles of Suspect, Interacting, or Drug Not Administered

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

Product in Aggregate Reporting Group

At least one Case Product or Case Combination Product links to a registration that matches a Product Registration Number in the Aggregate Reporting Group.

(case_version__vr.case_product__v.product_registration__v.registration_number__v OR case_version__vr.case_product__v.combination_product_registration__v.registration_number__v) IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_regi stration__v.registration_number__v

Malfunction Line Listing

Line Listing Summary for Combination Products

Malfunction Tabulation

Device Constituent has a Malfunction

A Case Product is a combination product that contains at least one device constituent, and the device constituent has a malfunction (Malfunction is set to Yes).

case_version__vr.case_product__v.malfunction__v = Yes WHERE case_version__vr.case_product__v.product_type__v = device

15-Day and Non-15-Day- Summary Reports

15-Day Report Line Listing Summary

Non-Expedited Line Listing Summary

Interval Line Listings

Malfunction Line Listing

Line Listing Summary for Combination Products

List of Death Cases

List of Nullified Cases

Initial vs. Follow-Up Report

To determine whether Cases should be listed in initial or follow-up reports, Vault evaluates the Transmission Reason (transmission_reason__v) field on FDA Transmissions within the reporting period using the following logic:

• Initial reports: When there is at least one FDA Transmission within the reporting period with the Transmission Reason set to one of the following:
  • Initial
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial)
    
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I
• Follow-up reports: When all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:
  • Amendment
  • Follow-Up
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification)
    
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1

The number of Cases with the Case > Report Type set to one of the following:

• Spontaneous
• Literature (Spontaneous)
• Other
• Not Available
• A custom Report Type with an E2B code of 1, 3, 4, or null (blank)
  case_version__v.report_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2

The sum of Cases with primary adverse events that meet the following criteria:

• Cases with one or more FDA Transmissions within the reporting period where the Local Expedited Criteria field is set to Yes or is blank.
  case_version__v.transmission__v.case_expedited__v = Yes OR Blank
• Serious (non-fatal): The Case Adverse Event > Seriousness field is set to a value, but the fatal criteria are not met.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Unlabeled: Vault looks for an Expected value of No in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = No)

The sum of Cases with primary adverse events that meet the following criteria:

• Cases with one or more FDA Transmissions within the reporting period where the Local Expedited Criteria field is set to Yes or is blank.
  case_version__v.transmission__v.case_expedited__v = Yes OR Blank
• Meets one of the following conditions to indicate a death occurred:
  • The Date of Death field on the Case is populated.
    case_version__v.dod_normalized__v ≠ Blank
  • The Seriousness field on any Case Adverse Event contains Results in Death.
    case_adverse_event__v.seriousness__v = results_in_death__v
  • The Outcome field on any Case Adverse Event contains Fatal.
    case_adverse_event__v.outcome__v = fatal
  • Any Case Adverse Event has a coded event under the MedDRA HLT of 10011907 (Death and Sudden Death).
    case_adverse_event__v.event_meddra__v.meddra__v.hlt_code__v = 10011907
  • The Autopsy field on the Case is set to Yes.
    case_version__v.autopsy_value__v = Yes

The sum of Cases with primary Case Adverse Events that meet the following criteria:

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Labeled: Vault looks for an Expected value of Yes in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = Yes)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Unlabeled: Vault looks for an Expected value of No in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = No)
• Not Related: The Causality Established field in at least two primary Assessment Results is set to No, including one company assessment and one reporter's assessment.
  (case_assessment__v.case_assessment_result__v.causality_established__v = No
where primary__v = True
and source_type__v.e2b_code__v = 1 [Investigator],
5 [Health Care Professional], or 6 [Non-Health Care Professional])
OR
(case_assessment__v.case_assessment_result__v.causality_established__v = No
where primary__v = True
and source_type__v.e2b_code__v = 2 [Sponsor] or 4 [MAH])

The sum of Cases with primary Case Adverse Events that meet the following criteria:

• Non Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Labeled: Vault looks for an Expected value of Yes in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = Yes)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

• Non Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Unlabeled: Vault looks for an Expected value of No in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = No)

Primary adverse events that meet the following criteria:

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to No.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No or Blank)

Primary adverse events that meet the following criteria:

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Labeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to Yes.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to Yes to be considered Labeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes)

Primary adverse events that meet the following criteria:

• Non Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to No.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No or Blank)

Primary adverse events that meet the following criteria:

• Non Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Labeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to Yes.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to Yes to be considered Labeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes)

Vault groups Cases based on the following Case criteria:

• 15-Day or non-15-Day
• Serious or non-Serious
• Initial or Follow-up
• Labelled or Unlabelled

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
2. The Expectedness field on the primary Case Assessment
3. The Case Expectedness field

Otherwise, Vault populates UL (unlisted).

Both the reported name and the MedDRA Preferred Term (PT) for the adverse events.
(IF event_reported_english__v ≠ BLANK
THEN case_adverse_event.event_reported_english__v
ELSE case_adverse_event.event_reported__v)
(event_meddra__v.PT)

Vault orders the adverse events by rank, blank values ranking last.

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {ACK Accepted | Completed}
• The Transmission Reason field is set to one of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. For each Transmission date listed in the Transmission Generation Date column, Vault displays one of the following:

• Exp Initial (expedited initial)
• Exp Follow-up (expedited follow-up)
• Non-Exp Initial (non-expedited initial)
• Non-Exp Follow-up (non-expedited follow-up)

Vault determines a Case is expedited if one or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No
Vault displays the values in the same order as the Transmission Generation Date values.

Vault determines a Case is an initial Case if at least one FDA Transmission within the reporting period has the Transmission Reason set to one of the following:

• Initial
• A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial).
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:

• Amendment
• Follow-Up
• A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification).
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.

Vault displays the total number of Cases on the report.

• WWID: Case > Worldwide UID
  case_version__v.worldwide_uid__v
• UID: Case > UID
  case_version__v.uid__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {ACK Accepted | Completed}
• The Transmission Reason field is set to one of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. Vault populates this field with one of the following values:

• Expedited Initial
• Expedited Follow-up
• Non-Expedited Initial
• Non-Expedited Follow-up

Vault determines a Case is expedited if one or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No

Vault determines a Case is an initial Case if at least one FDA Transmission within the reporting period has the Transmission Reason set to one of the following:

• Initial
• A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial)
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:

• Amendment
• Follow-Up
• A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification)
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.

Vault groups Cases based on the following Case criteria:

• 15-Day or non-15-Day
• Serious or non-Serious
• Initial or Follow-up
• Labelled or Unlabelled

Vault maps this value from the Transmission > FDA Report Type.
transmission__v.fda_report_type__v

If the FDA Report Type is 5-Day, Vault sets the value to 5-Day.

Otherwise, Vault sets the value to Other Reportable Malfunction.

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
2. The Expectedness field on the primary Case Assessment
3. The Case Expectedness field

Otherwise, Vault populates UL (unlisted).

Both the reported name and the MedDRA Preferred Term (PT) for the adverse events.
(IF event_reported_english__v ≠ BLANK
THEN case_adverse_event.event_reported_english__v
ELSE case_adverse_event.event_reported__v)
(event_meddra__v.PT)
Vault orders the adverse events by rank, blank values ranking last.

The FDA Device Code: Case product > Device Problem > Device Code> Level x Code, where "x" is the product term level (either 1, 2, or 3).
case_product__v.device_problem__vr.device_code__v.level "x" code

Vault sets the value using the following logic:

• If the Case Product contains an FDA Device Code of level 3, level 2, or level 1, Vault sets the value to this term and code.
• If the Case product > Device Problem field is blank, Vault sets the value to -.
• If a Case has more than one device with a device problem, Vault lists all the Device Codes from the Case.

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {ACK Accepted | Completed}
• The Transmission Reason field is set to one of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. For each Transmission date listed in the Transmission Generation Date column, Vault displays one of the following:

• Exp Initial (expedited initial)
• Exp Follow-up (expedited follow-up)
• Non-Exp Initial (non-expedited initial)
• Non-Exp Follow-up (non-expedited follow-up)

Vault determines a Case is expedited if one or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No
Vault displays the values in the same order as the Transmission Generation Date values.

Vault determines a Case is an initial Case if at least one FDA Transmission within the reporting period has the Transmission Reason set to one of the following:

• Initial
• A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial).
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:

• Amendment
• Follow-Up
• A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification).
  transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.

Vault maps this value from the Transmission > FDA Report Type.
transmission__v.fda_report_type__v

If the FDA Report Type is 5-Day, Vault sets the value to 5-Day.

Otherwise, Vault sets the value to Other Reportable Malfunction.

Cases in the Initial category include an initial Transmission in the report interval.

Cases in the Initial with Follow-up category include an initial Transmission and at least one follow-up Transmission in the report interval. This is a subset of the Initial category.

Cases in the Follow-up category do not include any initial Transmissions in the report interval.

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Submissions for Cases in each category.

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Cases in each category.

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Labeled: Vault looks for an Expected value of Yes in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States, or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = Yes)

• Serious: The Case Adverse Event > Seriousness field is populated.
  case_adverse_event__v.seriousness__v ≠ EMPTY
• Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to No.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No or Blank)


• Non-Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Labeled: Vault looks for an Expected value of Yes in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States, or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = Yes
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = Yes)

• Non-Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
  • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
    • A Case Assessment Expectedness record must exist with the Expected field set to No.
    • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
  • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No or Blank)


• WWID: Case > Worldwide UID
  case_version__v.worldwide_uid__v
• UID: Case > UID
  case_version__v.uid__v

Vault maps values from the following fields:

• Country: Case > Event Country
  case_version__v.event_country__v.name__v
• Sex: Case > Patient Sex
  case_version__v.gender_value__v.name__v
• Age: Case > Age and Age (unit)
  IF case_version__v.age_value__v = BLANK
THEN case_version__v.age_group__v.name__v
ELSE (case_version__v.age_value__v case_version__v.age_unit__v)

Vault maps the Product Names of all Case Products on the Case whose Drug Role is set to Suspect, Interacting, or Drug not Administered, ordered by rank.

case_version__v.case_product__v.product_name__v

Vault lists the MedDRA PT of all serious and non-serious adverse events on the Case. If the outcome of an adverse event is fatal, Vault appends the name of the outcome in parentheses. For example, Pyrexia (fatal).

Both MedDRA PT and reported term entered on the Case > Cause of Death record.

IF case_cause_of_death__v.cause_of_death_meddra_pt__c ≠ Blank
THEN (cause_of_death_meddra_pt__c)
AND IF case_cause_of_death__v.name_reported__v ≠ Blank
THEN (name_reported__v)
ELSE ""-""

The Autopsy value on the Case:

case_version__v.autopsy_value__v

The Date of Death on the Case:

case_version__v.dod_normalized__v

• WWID: Case > Worldwide UID
  case_version__v.worldwide_uid__v
• UID: Case > UID
  case_version__v.uid__v

The Transmission Date on the Transmission where the Reason on the Transmission is Initial, Follow-up, or Amendment.

transmission__v.transmission_date__v
WHERE
transmission__v.reason IN (I,2,F)

The Transmission Date on the Transmission where the Reason on the Transmission is Nullified.

transmission__v.transmission_date__v
WHERE
transmission__v.reason = 1

The Reason Text on the Transmission where the Reason on the Transmission is Nullified:

transmission__v.transmission_reason_text_long__v
WHERE
transmission__v.reason = 1

• WWID: Case > Worldwide UID
  case_version__v.worldwide_uid__v
• UID: Case > UID
  case_version__v.uid__v

The Name of the Case.

case_version__v.name__v

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
2. The Expectedness field on the primary Case Assessment
3. The Case Expectedness field

Otherwise, Vault populates UL (unlisted).

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).