# Create CIOMS II Reports Safety provides Council for International Organizations of Medical Sciences (CIOMS) II authoring and table generation capabilities. The 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 generates:

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

Note: Your Admin 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. * 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 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 enable 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. Note: The Reporting Family object type should be Product Family. To learn more, see Configure Aggregate Reporting Families.
Organization	Vault populates this field 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. Note: For Cases that have been nullified, ensure to change the Case Lifecycle State to a state that is not listed in the States to Include field. For example, if a nullified Case remains in the Closed state, Vault will still consider the Case in aggregate reports.
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. Note: For each clinical trial in the CIOMS II reporting family, Vault will use the first option (Use Approved Version at the beginning of the reporting period) regardless of which option for Datasheet is selected above. For each product in the CIOMS II reporting family, Vault will use whichever option for Datasheet is selected above. 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 Preview¹ 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: * Study Product Datasheets * Study Core Datasheets * Product Core Datasheets 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.

Note: If an active start date is defined for the term on the Datasheet, Vault 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 Vault 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.

Note: For blinded studies, Vault populates blinded product information as Blinded in the generated tables. If the Blinded Placeholder Name field is populated then this will display on the report instead of the generic Blinded label.

### CIOMS II 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`)

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, 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

Note: To include Case Products with the Drug Role of Drug Not Administered when generating PADERS, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered

##### 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	Spontaneous Literature (Spontaneous) A custom Report Type with an E2B Code of `1`	Serious (not blank)	Any	Any
1	`case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 1` `AND case_version_v.seriousness__v ≠ blank`
2	Spontaneous Literature (Spontaneous) A custom Report Type with an E2B Code of `1`	Blank (Non-Serious)	Unexpected	Any
2	`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	Study Literature (Study) A custom Report Type with an E2B Code of `2`	Serious (not blank)	Any	For any primary Case Assessment: Yes Unknown Blank
3	`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	Other Not Available A custom Report Type with an E2B Code of `3` or `4`	Serious (not blank)	Any	Any
4	`case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 3 OR 4` `AND case_version_v.seriousness__v ≠ blank`
5	Other Not Available A custom Report Type with an E2B Code of `3` or `4`	Blank (Non-Serious)	Unexpected	Any
5	`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
	MAH Case Reference Number	The value from the Case UID field. `case_version__v.uid__v`
	Source	The value selected in the Case Report Type field. `case_version_v.report_type__v`
	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`
	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 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)`
	Product Route, Formulation, Daily Dose	The following information is listed: Daily Dose: Values are mapped from the following fields: Dose (number) and Dose (unit) `case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v` 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.
	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)`
	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`
	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.
	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`
	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.

[1]: #original