Create CIOMS II Reports

Learn how to set up and generate CIOMS II reports.

About CIOMS II Reports

Vault Safety provides Council for International Organizations of Medical Sciences (CIOMS) II authoring and table generation capabilities. The Vault Safety CIOMS II report adheres to the ICH E2C(R1) regulatory guideline. You can also generate reports in the CIOMS II line listing format using filters such as Report Type, Case Seriousness, and Case Expectedness that do not use PSUR regulations logic.

The following table summarizes the CIOMS II tabulations that Vault Safety generates:

Tabulation Generated by Default? Masking Support?
CIOMS II Interval Line Listing of Adverse Drug Reactions Yes Yes

Prerequisites

Consider the following prerequisites before you generate CIOMS II 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.
  • Your Admin must have enabled CIOMS II Line Listings.
  • To filter reports by country as well as generate reports in the CIOMS II line listing format using filters unrelated to PSUR regulations logic, your Admin must also enable Additional Filters for CIOMS II Aggregate Report.
  • The Reporting Family is set up with the Products, Studies, and Substances to include in the CIOMS II tabulations and CIOMS II line listings.
  • Your Admin must have configured a Datasheet for each Product, Product Registration, Study, or Study Product with a list of expected adverse events for the reporting family.
    • Vault Safety uses these Datasheets to classify adverse events as listed or unlisted in CIOMS II tabulations.
  • To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must have enabled the Criteria Page for Aggregate reports.

Create a CIOMS II Aggregate Report

Create a CIOMS II Aggregate Report and specify the report settings.

Add a CIOMS II

  1. In the Vault primary navigation bar, select Aggregate Reports > CIOMS II and then select Create.
  2. In the Create Aggregate Report window, under Select Aggregate Report Type select CIOMS II.
  3. Complete the fields on the Create CIOMS II page.
    • Populate the Original CIOMS II Logic field to specify what kind of logic you want the report to consider:
      • Select Yes to generate a CIOMS II line listing report using PSUR regulations logic.
      • Select No to generate reports in the CIOMS II line listing format using filters unrelated to PSUR regulations logic and to reveal additional filters.
  4. (Optional) To limit the report to specific countries, add the applicable locations in the Country section.
  5. Save the record.

Result

The CIOMS II record enters the Pending state. Vault assigns a task to users in the Safety Writer role to review the report details.

CIOMS II Fields

You can specify the following fields for a CIOMS II Aggregate Report:

Field Description
Product Family (Required)

Select the Reporting Family configured for aggregate reporting.

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.

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

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

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

Enter the end date for the reporting period.

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

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

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

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

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

When selected, the criteria page summarizes the following:

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

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

By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. 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.
Original CIOMS II Logic

Select Yes to generate the standard CIOMS II line listing report based on PSUR regulations to filter Cases.

Select No to generate a variety of reports in the CIOMS II line listing format based on filters that do not consider PSUR logic.
Report Type

Select the report type to include in the report.

This field appears when you select No for Original CIOMS II Logic.
Case Serious

Select Yes or No to generate Cases with matching values.

This field appears when you select No for Original CIOMS II Logic.
Case Relatedness

Select the relatedness values to include in the report.

This field appears when you select No for Original CIOMS II Logic.
Case Expectedness

Select the expectedness values to include in the report.

This field appears when you select No for Original CIOMS II Logic.
Expectedness Source

Specify how the report calculates expectedness. Select Datasheets to calculate from Datasheets or Case to calculate from Case Assessments.

This field appears when you select No for Original CIOMS II Logic.
Drug Roles to Include

Select one or more Drug Roles from the dropdown list to include in the Interval Line Listing of Adverse Drug Reactions tabulations.

The Suspect and Interacting Drug Roles are selected by default for CIOMS II reports created with the 23R3 release or later. For CIOMS II reports created from prior releases, update the field to specify or revise which Drug Roles to include in the report.
Generate Masked Documents

Select this option to generate a masked copy of the Interval Line Listings of Adverse Drug Reactions table for masked distributions

To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR).
Include Criteria Page on Documents Select this option for the cover page to list the criteria used to generate the report.
Indicate Unexpected Term

Select Yes to display the 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 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 Manage Datasheets and Auto-Expectedness.
Comments

To customize the reports, select optional fields to be included in the report. Most of these will appear in the comments area of the report.

You can select the following options:

  • Assessment Results
  • Study ID (will display in the source column when applicable)
  • EudraCT Number
  • Patient ID
  • Action Taken
  • Narrative Preview [1]
  • Company Comments
  • Reporter's Comments
Countries

To filter by country, select Add in the Countries section to use the Search: Country dialog to specify the countries to include in the report. The report will include all Cases with a matching Reporter Country as well as all Cases with a matching Event Country for Case Adverse Events.
[1] This option requires the Allow Narrative Preview to be included in the report Aggregate Report setting to be enabled in your Vault. This setting is enabled by default. See the Narrative Preview Option for CIOMS II Reports for more information.

Generate CIOMS II 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 CIOMS II report tables.

Mark Unexpected Terms in CIOMS II Reports

You can set the Indicate Unexpected Term on CIOMS II reports so that Vault marks each unexpected adverse event.

To identify unexpected events, your Admin must have configured a Datasheet for each Study and Product in the CIOMS II Reporting Family. Where they exist, Datasheets are evaluated by Vault in the following priority order:

Datasheets 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 CIOMS II Start Date must be within a term’s active range to be considered expected.

Expectedness in Aggregate Reports provides more information.

CIOMS II Table Generation Data Mapping

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

CIOMS II Interval Line Listing of Adverse Drug Reactions

Interval Line Listing of Adverse Drug Reactions

Table Constraints

Vault filters Cases to include in the CIOMS II Interval Line Listing of Adverse Drug Reactions using the following constraints:

Case Not Suppressed

The Case Suppress Submission field must be set to No or blank (not suppressed).
case_version__v.suppress_submission__v ≠ Yes

Case Lifecycle State in Aggregate States to Include

The latest Case version within the reporting period must be in a state specified in the States to Include field on the CIOMS II. case_version__v.state__v CONTAINS cioms_ii__v.states_to_include__v

Consider the folllowing:

  • Cases in the following states are omitted:
    • Nullified (nullified_state__v)
    • Voided (voided_state__v)
  • If the Case is in a Lifecycle State assigned a State Type of “Deleted”, the Case is omitted.
  • When evaluating the States to Include field, Vault 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 ≥ cioms-ii__v.data_period_start__v AND
DATE ≤ cioms-ii__v.data_period_end__v

where DATE depends on the option selected in the CIOMS II Filter Cases By (cioms-ii__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, Interacting, or Drug Not Administered Case Product or Substance in Reporting Family

A Case Product must meet both of the following conditions:

  • The Case Product must be a member of the Reporting Family

    case_version__vr.case_product__v.product__v IN
    aggregate_report_family__vr.aggregate_report_family_join__vr.products__v

    OR
    The Case Product must have a Product Substance that is a member of the Reporting Family

    reporting_family_v.substance__v.substance_v ≠ BLANK
    AND reporting_family_v.substance__v.substance_v =
    case_product__v.product__v.product_substance__v

  • The Drug Role field must be set to Suspect (E2B Code=1), Interacting (E2B Code=3), or Drug Not Administered (E2B Code=4)

    case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4

Case Report Type, Seriousness, Expectedness, and Causality

To generate reports using the original CIOMS II logic based on PSUR regulations, 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 Source The value selected in the Case Report Type field.
case_version_v.report_type__v
3 Country of Event The value in the Case Event Country field.
case_version__v.event_country__vr.name__v
If the Case Event Country field is blank, the value in the Reporter Country field is used instead. A legend on the report criteria page indicates the mapping.
case_version_v.reporter_country__vr.name__v
4 Sex
Age		 Values from the following fields:
  • Sex: Case > Patient Sex
    case_version__v.gender_value__v.name__v
  • Age: Case > Age value and unit
    Vault automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v)
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
5 Product Route, Formulation, Daily Dose 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 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)
7 Date of Onset
Time to Onset		 These values are mapped as follows:
  • 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
  • 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 Description of Reaction as Reported (PT) The list of adverse events, including the reported term, the MedDRA preferred term, and the Seriousness from each Case Adverse Event.
  • Reported:
    case_adverse_event__vr.event_reported__v
  • MedDRA:
    case_adverse_event__vr.event_meddra__vr.pt_term__v
  • Serious:
    IF case_adverse_event_vr.seriousness_v = blank THEN "Non-serious" ELSE "Serious"

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

The value selected in the Case Adverse Event Outcome field.

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


case_adverse_event__v.event_outcomes__v.name__v
where case_adverse_event__v.primary__v = Yes
10 Comments Values from the following fields:
  • Any text entered in the Case Reporting Summary field. You can use this field to highlight causality information.
    case_version__v.reporting_summary__v
  • Any Case Assessment Result Source Type and Assessment Result for the combination of Suspect Drug(s) and Serious ADR(s) listed in the report, with the fields mapped as follows:
    • When the Source Type and the Assessment Result (Override) fields are populated:
      case_assessment__v.case_assessment_result__v.source_type__v:
      case_assessment__v.case_assessment_result__v.assessment_result_override__v
      Example: "Sponsor: Not Applicable"
    • When the Assessment Result (Override) field is not populated and the Source Type and the Assessment Result fields are populated:
      case_assessment__v.case_assessment_result__v.source_type__v:
      case_assessment__v.case_assessment_result__v.assessment_result__v
      Example: "Sponsor: Related"
    • When the Source Type field is not populated:
      [Blank]: case_assessment__v.case_assessment_result__v.assessment_result_override__v
      or
      [Blank]: case_assessment__v.case_assessment_result__v.assessment_result__v
      Example: "[Blank]: Related"
  • Assessment Results are listed in the same row as the suspect drug.