Create CIOMS II Reports

Learn how to set up CIOMS II reports

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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.

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

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.
  • An administrator must have enabled CIOMS II Line Listings
  • The Reporting Family with the Products, Studies, and Substances to include in the CIOMS II tabulations and CIOMS II line listings.
  • An administrator must have configured each product’s Core Datasheet with a list of expected adverse events for the reporting family product.
    Vault Safety uses Core Product Datasheets to classify adverse events as listed or unlisted in CIOMS II tabulations.

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.

    Note If you do not see CIOMS II as an option, an administrator must update your vault to enable CIOMS II.

  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.
  4. Save the record.

Result

The CIOMS II record enters the Pending state. The system 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.

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 tabulations do not consider the start date. Cumulative tabulations include all Cases from the product International Birth Date (IBD) to the Data Period End.

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.

Generate Masked Documents

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

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 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 PSUR and CIOMS II reports:

  • Use Approved Version at the beginning of the reporting period: The aggregate report Start Date must be within a term's active range to be considered Expected. This option is used by default, including when this field is left blank.
  • Use Approved Version at the end of the reporting period: The aggregate report End Date must be within a term's active range to be considered Expected.
To learn more, see Active Range for Expectedness in Aggregate Reports.
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

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 a CIOMS II report so that the system marks each unexpected adverse event.

To identify unexpected events, an administrator must have configured the Core Datasheet for the products in the CIOMS II 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 CIOMS II Start Date must be within a term’s active range to be considered expected.

Expectedness in Aggregate Reports provides more information.

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

CIOMS II Table Generation Data Mapping

CIOMS II Interval Line Listing of Adverse Drug Reactions

Table Constraints

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

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • Case Lifecycle State in Aggregate States to Include

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

    case_version__v.state__v CONTAINS cioms_ii__v.states_to_include__v

    Note the following considerations:

    • Cases in the following states are omitted:
      • Nullified (nullified_state__v)
      • Voided (voided_state__v)

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

    • If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted.
    • When evaluating the States to Include field, the system evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).
  • Case Date in Interval Reporting Period

    The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

    DATE ≥ 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 or Interacting Case Product or Substance in Reporting Family
    A Case Product must meet both of the following conditions:
    • The Case Product must be a member of the Reporting Family
      case_version__vr.case_product__v.product__v IN 
      			    			
      aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
      OR
      The Case Product must have a Product Substance that is a member of the Reporting Family
      reporting_family_v.substance__v.substance_v ≠ BLANK 
      AND reporting_family_v.substance__v.substance_v =
      case_product__v.product__v.product_substance__v
    • The Drug Role field must be set to Suspect (E2B Code=1) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • Case Report Type, Seriousness, Expectedness, and Causality
    The Case must match one of the following scenarios:
    Scenario Report Type Seriousness Expectedness Causality Established
    1 Serious (not blank) Any Any
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
    					        		
    AND case_version_v.seriousness__v ≠ blank
    2 Blank (Non-Serious) Unexpected Any
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1
    					        		
    AND case_version_v.seriousness__v = blank
    AND case_version_v.expected__v = false
    3 Serious (not blank) Any For any primary Case Assessment:
    • Yes
    • Unknown
    • Blank
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
    					        		
    AND case_version_v.seriousness__v ≠ blank
    AND case_assessment__v.case_assessment_result__v.causality_established__v =
    Yes OR Null OR Unknown
    WHERE case_assessment__v.case_product__v.primary__v = True
    4 Serious (not blank) Any Any
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
    					        		
    AND case_version_v.seriousness__v ≠ blank
    5 Blank (Non-Serious) Unexpected Any
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4
    					        		
    AND case_version_v.seriousness__v = blank
    AND case_version_v.expected__v = false

Table Mapping

Number Name Description
1 MAH Case Reference Number The value from the Case UID field.
case_version__v.uid__v
2 Source The value selected in the Case Report Type field.
case_version_v.report_type__v
3 Country of Event The value from the Case Event Country field.
case_version__v.event_country__vr.name__v
4 Sex
Age
Values from the following fields:
  • Sex: Case > Patient Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age value and unit
    The system automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v)
                         
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
5 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 both the reported term and MedDRA preferred term from each Case Adverse Event.
  • Reported:
    case_adverse_event__vr.event_reported__v
  • MedDRA:
     case_adverse_event__vr.event_meddra__vr.pt_term__v

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

9 Patient Outcome

The value selected in the Case Adverse Event Outcome field.

If there are multiple Case Adverse Event records on a Case, the system populates the most serious outcome.

case_adverse_event__v.event_outcomes__v.name__v
              
where seriousness__v ≠ blank
10 Comments Any text entered in the Case Reporting Summary field. You can use this field to highlight causality information.
case_version__v.reporting_summary__v

Create PSUR and CIOMS II Line Listing Reports
How Aggregate Reports Filter by Data Period

Related Docs

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