CIOMS I Generation Data Mapping

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

Sections in This Article

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 lower-level term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.

    Note You can opt to populate the MedDRA preferred term (PT) for adverse events instead of the LLT. This feature is available by request only. Contact Veeva Support to request this feature.

  • 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.

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 selected in the Event Country field on the primary Case Adverse Event.
2. Date of Birth The date entered in the Date of Birth field on the Case, rounded to two decimals.
2a. Age The 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 Gender field on the Case.
3a. Weight The 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 date from the Start Date field on the primary Case Adverse Event.
7 + 13 Describe Reaction(s) This field is populated with the following information:
  • Text from the Narrative Text field.
  • Any text from the Sender's Comments field.
    Note that if the narrative text overflows onto additional pages, the sender’s comments will also appear on the overflow pages.
  • The following data is populated for each Case Lab Test Result record, ordered alphabetically and by date:
    • [Test Name (MedDRA) and Test Name (Reported)],
    • Test Date,
    • [Result Code or Result Qualifier + Result Value + Result (unit)],
    • Result Free Text,
    • (Normal Low Value - Normal High Value) Result Unit,
    • Result Free Text,
    • Comments
  • The following data is populated for each Case Adverse Event:
    Name (Reported) [Name (MedDRA)], Seriousness: Seriousness, Outcome: Outcome

    Note If neither the reported term or MedDRA term are available, a Case Adverse Event is not added to this form. Also, when multiple seriousness criteria are entered, only the most serious value is populated in this section.

  • If the adverse event resulted in death, the following information is populated from each Case Cause of Death record:
    • Reported Causes of Death: [Name (MedDRA) or Name (Reported)]
    • Autopsy Causes of Death: [Name (MedDRA) or Name (Reported)]
8-12 Check All

The appropriate check boxes are selected, based on the Seriousness criteria for each Case 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 hospitalisation
  4. Disabling / incapacitating
  5. Congenital anomaly / birth defect
  6. Other medically important condition

II. Suspect Drug(s) Information

II. Suspect Drug(s) Section
CIOMS I Field Populated Value
14. Suspect Drug(s)

The following information is populated for Case Products assigned a Drug Role of Suspect or Interacting:

  • Name: If the Product (Coded) (product_name__v) field is populated on the Case Product, that value is mapped. Otherwise, the value is mapped from the Product (Reported) 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 and Frequency fields on the primary Case Product Dosage. If there is no value in the Dose field, the value is taken from the Dose Text field.
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) N/A
Dose Increased
Dose Not Changed
Not Applicable
3
4
9
Any N/A
Unknown 0 Any N/A
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 no - n/a, then the Not Applicable check box is selected.

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 or Product (Reported)],
  • [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 check boxes are selected, depending on the following logic:
Check box 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 check box 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 Timezone in your user settings.
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 Timezone in your user settings.

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. Note that 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 overflow pages.

Assessment Results in Overflow Pages

Any Case Assessment Results associated with the Case are listed in the overflow 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
CIOMS Case Assessment Results Section

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.

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

*Product Name Mapping

The way the system maps the product name during report generation depends on the product blinding settings:

  • If the Case is a non-study or an open-label study Case, the product name is mapped from the Name (product_name_v) field on the Case Product record.
  • If the Case is a blinded study Case, the system uses the following logic to map the product name:
    Criteria (Inputs) Form Generation
    Does the Study 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

FDA 3500A Generation Data Mapping
E2B Generation Data Mapping
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