# CIOMS I Generation Data Mapping Learn how Vault generates the CIOMS I form from a _Case_. For information on how Vault generates a localized CIOMS I form for _Localized Cases_ reportable to China, see CIOMS I (Chinese) Generation Data Mapping. The following list describes how Vault handles certain data while generating a CIOMS I form: * For events, diagnoses, indications, test names, and medical conditions, Vault always populates the MedDRA Lowest Level Term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.

Note: Your Admin can configure your Vault to populate the MedDRA Preferred Term (PT) for adverse events instead of the LLT. See Enable Export Product (Reported) to CIOMS I and FDA 3500A for details on setting the default value for export.

* Dates are populated using the format `dd-mmm-yyyy`. Blank dates are populated as dashes (-\-\-). * Certain fields may be masked, depending on the blinding settings on the Case or masking settings on the Distribution. Generate Masked Distributions describes the fields that may be masked. * Open-label Products within blinded Studies may be unmasked, depending on your Admin's configuration of Show Unmasked Open-Label Products on Blinded Forms ### Optional Configuration To evaluate Case Products with the Drug Role of Drug Not Administered as suspect, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Vault evaluates only Case Products with the Suspect or Interacting Drug Role as suspect. ## I. Reaction Information

CIOMS I Field	Populated Value
1 Patient Initials	The value entered in the Patient Initials / ID field on the Case.
1a. Country	The two-letter country code and name of the country is populated based on one (1) of the following fields, ordered by priority: Event Country on the Case Event Country on the primary Case Adverse Event Country on the primary Reporter-type Case Contact Reporter Country on the Case If none of these fields are populated, no value is exported.
2. Date of Birth	The date entered in the Date of Birth field on the Case.
2a. Age	This value is mapped from one of the following Case fields, ordered by priority: Age (normalized) Age (value and unit) Age Group
3. Sex	The value from the Sex field on the Case.
3a. Weight	This value is mapped from one of the following Case fields, ordered by priority: Weight (normalized) Weight (value and unit)
4-6 Reaction Onset	The earliest Onset Date for any Case Adverse Event associated with the Case version. This field is masked if the Onset (reason omitted) field on the Case Adverse Event is "Masked".
7 + 13 Describe Reaction(s)	This field is populated with the following information: Text from the Narrative on the Case. Any text from the Company Comments field. If the narrative text overflows onto additional pages, the company comments will also appear on the overflow pages. The following data is populated for each Case Test Result record, ordered alphabetically and by date: [Test Name (MedDRA) and Test Name (Reported)], Test Date, [Result (Code) or Test Result Qualifier + Result (Value) + Result (Unit) or Result (Unit) Text], Result (Text), (Normal Low Value - Normal High Value) Result (Unit) or Result (Unit) Text, Result (Text), Comments The following data is populated for each Case Adverse Event: Event (Reported) - English [Event (MedDRA)], Seriousness: Seriousness, Outcome: Outcome Note: If the Event (Reported) - English field is not available, Vault uses the Event (Reported) field instead. If both the reported event and MedDRA event are unavailable, a Case Adverse Event is not added to the form. Also, when multiple seriousness criteria are entered, only the most serious value is populated. If the adverse event resulted in death, the following information is populated from each Case Cause of Death record: Reported Causes of Death: [Cause (MedDRA) or Cause (Reported)] Autopsy-Determined Cause of Death: [Cause (MedDRA) or Cause (Reported)]
8-12 Check All	The appropriate checkboxes are selected, based on the Seriousness criteria for each Adverse Event associated with the Case. If there are multiple Seriousness values selected for a Case Adverse Event, Vault populates the checkbox corresponding to the most severe value, according to the following order (from most severe to least): Results in death Life threatening Caused / prolonged hospitalization Disabling / incapacitating Congenital anomaly / birth defect Other medically important condition or Required Intervention to Prevent Permanent Impairment/Damage (Devices)

## II. Suspect Product(s) Information

CIOMS I Field

Populated Value

14. Suspect Product(s)

Vault populates this information for Case Products with an eligible Drug Role:

Name: By default, if a Product (Reported) value exists on the Case Product, Vault maps that value. Otherwise, Vault maps the Product (Coded) value. If the associated Product record includes a Generic Name, Vault appends the value in parentheses after the name.

Note: Your Admin can configure your Vault to export the Product (Coded) value by default. See Enable Export Product (Reported) to CIOMS I and FDA 3500A for details.
Batch/Lot #: The Batch/Lot Number on the associated Case Product Dosage.
Either MPID: MPID or PHPID: PHPID

15. Daily Doses

The values and units in the Dose, Frequency, and Dose Text fields on the primary Case Product Dosage.

16. Route(s) of Administration

The value entered in either the Patient RoA or Patient RoA (Reported) field on the associated Case Product Dosage.

For parent-child cases, the routes of administration are listed for both the patient (child) and the parent.

17. Indication(s) for Use

The value entered in either the Name (MedDRA) or Indication (Reported) field on the associated Case Product Indication record.

18. Therapy Date(s)

This field is populated with the following fields for each associated Case Product Dosage record:

[First Admin Date or --- or unk] to [Last Admin Date or --- or unk]

19. Therapy Duration

The value and unit entered in the Duration field on the associated Case Product Dosage record.

Vault updates the Duration field value to "Ongoing" if any of the following values are in the Action(s) Taken field:

Dose Reduced
Dose Increased
Dose Not Changed

20. Did Reaction Abate After Stopping Drug?

Vault uses the following fields to calculate whether a dechallenge test occurred and populate the appropriate checkbox:

Action Taken on the primary Case Product
Outcome on the primary Case Adverse Event

The following table outlines how different values in these fields populate this field on the CIOMS I form:

Action Taken (G.k.8)	E2B Code*	Outcome (E.i.7)	CIOMS I II.20 Box
Drug Withdrawn Dose Reduced	1 2	Recovered/Resolved Recovering/Resolving Recovered/Resolved with Sequalea	Yes
Drug Withdrawn Dose Reduced	1 2	Not Recovered Not Resolved Ongoing Fatal	No
Drug Withdrawn Dose Reduced	1 2	Unknown (blank)	(blank)
Dose Increased Dose Not Changed Not Applicable	3 4 9	Any	N/A
Unknown	0	Any	(blank)
Any other condition			(blank)
*Includes custom Action Taken Controlled Vocabulary records

21. Did Reaction Reappear After Reintroduction?

Vault uses the Reaction Recurrence field on the primary Case Assessment to determine whether a rechallenge test occurred and populate the appropriate checkbox.

If the Reaction Recurrence field is set to yes – yes (rechallenge was done, reaction recurred), then the Yes checkbox is selected.
If the Reaction Recurrence field is set to yes - no (rechallenge was done, reaction did not recur), then the No checkbox is selected.
If the Reaction Recurrence field is set to any of the following options, then the N/A checkbox is selected:
- yes - unk (rechallenge was done, outcome unknown)
- no - n/a (no rechallenge was done, recurrance is not applicable)
- The field is left blank

## III. Concomitant Drug(s) and History

CIOMS I Field Populated Value

22. Concomitant Drug(s) and Dates of Administration

CIOMS I Field	Populated Value
22. Concomitant Drug(s) and Dates of Administration	The following information is repeated for each associated Case Product record, populated from the following fields: [Product (Coded) (`product_name__v`) if the field is populated, else Product (Reported) (`product_reported__v`)], [First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration) Action(s) Taken, [Dose or Dose Text] + Frequency, Indication
23. Other Relevant History	The following information is populated: For each Case Medical History record: Disease / Surgical Procedure (MedDRA), [Start Date or ---] to [End Date or --- or Continuing], Comments Any text entered in the Medical History Text field on the Case is populated after listing each medical history line item. For each Case Drug History record: Drug Coded Name, [Start Date or ---] to [End Date or ---], Indication MedDRA

The following information is repeated for each associated Case Product record, populated from the following fields:

[Product (Coded) (product_name__v) if the field is populated, else Product (Reported) (product_reported__v)],
[First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration) Action(s) Taken,
[Dose or Dose Text] + Frequency,
Indication

23. Other Relevant History

The following information is populated:

For each Case Medical History record:
- Disease / Surgical Procedure (MedDRA),
- [Start Date or ---] to [End Date or --- or Continuing],
- Comments
Any text entered in the Medical History Text field on the Case is populated after listing each medical history line item.
For each Case Drug History record:
- Drug Coded Name,
- [Start Date or ---] to [End Date or ---],
- Indication MedDRA

## IV. Manufacturer Information

CIOMS I Field	Populated Value
24a. Name and Address of Manufacturer	The contact information is populated from the user selected in the Sender User field on the associated ICSR Transmission. When generating a form preview from the Case, the contact information is populated with the contact details for the Case Organization.
24b. MFR Control No.	The value from the UID field on the Case.
24c. Date Received by Manufacturer	Initial Cases: The date is mapped from the Case New Info Date field. If the New Info Date is not populated, the date is mapped from the Case Receipt Date field. A Case is considered initial when it meets one of the following conditions: For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code `I` (Initial) For a report preview generated from a Case, the Version must be less than or equal to 1.0 Follow-Up: The date is mapped from the Case New Info Date field. A Case is considered follow-up when it meets one of the following conditions: For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code `I` For a report preview generated from a Case, the Version must be greater than 1.0
24d. Report Source	Vault selects Report Source checkboxes as follows: Study: Checked when the Report Type of the Case corresponds to a Report Type controlled vocabulary with E2B Code `2`. In the standard Vault template, this includes: Study Literature (Study) Literature: Checked when the Report Type of the Case corresponds to a Report Type controlled vocabulary with Yes in the Literature field. In the standard Vault template, this includes: Literature (Spontaneous) Literature (Study) Health Professional: Checked when the Qualification of the primary Reporter-type Case Contact corresponds to a Qualification controlled vocabulary with Yes in the Qualified HCP field. In the standard Vault template, this includes: Dentist Pharmacist Physician Physician Assistant Nurse Nurse Practitioner Other health professional
25a. Report Type	The appropriate checkbox is selected, depending on whether the Case is initial or follow-up. The Report Type is determined with the following logic: If a Transmission record exists for the Case and a value is populated in the Transmission Reason field: If the Transmission Reason is Initial, the Report Type field is set to Initial. If the Transmission Reason is populated with any other value, the Report Type field is set to Follow-Up. If there is no Transmission record associated with the Case: If the Case New Info Date is less than or equal to the Case Receipt Date, the Report Type field is set to Initial. If the Case New Info Date is greater than the Case Receipt Date, the Report Type field is set to Follow-Up.
25b. Name and Address of Reporter	Unless excluded for a specific partner, Vault populates the name and address of the primary Case Reporter.
Date of This Report	The date when the report was generated, according to the Vault's Timezone.
26. Remarks	The text entered in the CIOMS Remarks field on the Case.

## Footer The left-side of the CIOMS I footer is timestamped with the date and time when the form was generated, according to the Vault's Timezone. The right-side of the footer is populated with the Case UID, appended with the value in the **Follow-up Number** field on the associated ICSR _Transmission_. The follow-up number will be appended when present on the Transmission, even when the Case type is not a Follow-Up Case. ## Additional (Overflow) Pages When Vault generates the CIOMS I form, any text that exceeds field character limits is overflowed to additional pages. The indicator "(...)" and/or "(Continued)" is appended to any field or section that continues on additional pages. Any text on the additional pages is identified with the relevant section and field. Any Case Assessment Results associated with the Case are also listed in the additional pages. ### Assessment Results in Overflow Pages Any Case Assessment Results associated with the Case are listed in the additional pages. For example: * Cholecap⇄Yellow Fever, Healthcare Professional, EU Method of Assessment, Reasonable Possibility * *****⇄Yellow Fever, Sponsor, EU Method of Assessment, Reasonable Possibility Each record is listed in the following format:

For unblinded double-blinded Studies, if there is a specified value in the Assessment Result (Override) field, Vault uses this value instead of the **Assessment Result** value for unmasked CIOMS I Transmissions and previews. An administrator must perform configurations and contact Veeva Support to request this feature be made available in your Vault.

Note: There is a limitation where if there is a specified value in the Assessment Result (Override) field, Vault will always generate the masked version of aggregate reports. This limitation will be addressed in a future release.

***Product Name Mapping** The way Vault maps the Product name during report generation depends on the Product blinding settings: * For non-Study Cases, open-label Study Cases, and open-label Products within blinded Studies, the Product name is mapped from the **Name** (`product_name_v`) field on the **Case Product** record.

Note: Your Admin must configure unmasked export of open-label Products within blinded Studies. If this feature is not turned on, open-label Products within blinded Studies are mapped as described in the next bullet.

* For blinded Study Cases, Vault uses the following logic to map the Product name for blinded Products:

Criteria (Inputs)		Form Generation
Does the Study Have Arms? (study_has_arms_v)	Is the Case Blinded? (blinded_v)	Document Masking	Product Name Mapping	Example
No	No	Unblinded	Case Product > Name (`product_name_v`)	Cholecap
No	No	Blinded	*****	*****
No	Yes or Blank	Unblinded	N/A: Document not generated
No	Yes or Blank	Blinded	*****	*****
Yes	No	Unblinded	Case Product > Name (`product_name_v`)	Cholecap
Yes	No	Blinded	Case Product > Blinded Name (Placeholder) (`study_product_placeholder__v`)	Cholecap vs. Placebo
Yes	Yes or Blank	Unblinded	N/A: Document not generated
Yes	Yes or Blank	Blinded	Case Product > Blinded Name (Placeholder) (`study_product_placeholder__v`)	Cholecap vs. Placebo