CIOMS I Generation Data Mapping

Learn how Vault Safety generates the CIOMS I form from a Case.

The following list describes how the system handles certain data while generating a CIOMS I form:

  • For events, diagnoses, indications, test names, and medical conditions, Vault Safety 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.
  • 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, the system evaluates only Case Products with the Suspect or Interacting Drug Role as suspect.

I. Reaction Information

I. Reaction Information Section

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:

  1. Event Country on the Case
  2. Event Country on the primary Case Adverse Event
  3. Country on the primary Reporter-type Case Contact
  4. 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:

  1. Age (normalized)
  2. Age (value and unit)
  3. 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:

  1. Weight (normalized)
  2. 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
  • 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, the system populates the checkbox corresponding to the most severe value, according to the following order (from most severe to least):

  1. Results in death
  2. Life threatening
  3. Caused / prolonged hospitalization
  4. Disabling / incapacitating
  5. Congenital anomaly / birth defect
  6. Other medically important condition or Required Intervention to Prevent Permanent Impairment/Damage (Devices)

II. Suspect Product(s) Information

II. Suspect Product(s) Section

CIOMS I Field Populated Value
14. Suspect Product(s)

The following information is populated for Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered:

  • Name: By default, if the Product (Reported) (product_reported__v) field is populated on the Case Product, that value is mapped. Otherwise, the value is mapped from the Product (Coded) (product_name__v) field.
  • Batch/Lot #: The value entered in the Batch/Lot Number field on the associated Product Dosage record.
  • 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.

The system 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? The system 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? The system 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

III. Concomitant Drug(s) and History Section

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

IV. Manufacturer Information

IV. Manufacturer Information Section

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 Transmission (Submission or Distribution) record.

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:
  1. For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code I (Initial)
  2. 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:
  1. For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code I
  2. For a report preview generated from a Case, the Version must be greater than 1.0
24d. Report Source The appropriate Report Source checkboxes are selected, depending on the following logic:
Checkbox Logic
Study

Checked when the option selected in the Case > Report Type field corresponds to a Report Type Controlled Vocabulary where E2B Code=2.

In the standard Vault template, the following Report Types check this box:

  • Study
  • Literature (Study)
Literature

Checked when the option selected in the Case > Report Type field corresponds to a Report Type Controlled Vocabulary where Literature=Yes.

In the standard Vault template, the following Report Types check this box:

  • Literature (Spontaneous)
  • Literature (Study)
Health Professional

Checked when the option selected in the Reporter-type Case Contact > Qualification field corresponds to a Qualification Controlled Vocabulary where Qualified HCP=Yes.

In the standard Vault template, the following Qualifications check this box:

  • 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:

  1. If a Transmission record exists for the Case and a value is populated in the Transmission Reason field:
    1. If the Transmission Reason is Initial, the Report Type field is set to Initial.
    2. If the Transmission Reason is populated with any other value, the Report Type field is set to Follow-Up.
  2. If there is no Transmission record associated with the Case:
    1. If the Case New Info Date is less than or equal to the Case Receipt Date, the Report Type field is set to Initial.
    2. 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 This field is populated using the name and address on the primary Case Reporter record.
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.

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 Transmission (Submission or Distribution) record.

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 Safety 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:

Case Assessment Results Section CIOMS

For unblinded double-blinded Studies, if there is a specified value in the Assessment Result (Override) field, the system 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.

*Product Name Mapping

The way the system 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.
  • For blinded Study Cases, the system 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