About the Case Page

The records and fields on the Case page simplify entering Case details into the system.

Default Case Page Sections

The following table describes the default sections on the Case page. Depending on your configuration, some or all of these sections may appear.

When processing Cases that may be reportable to the PMDA, see Complete Intake and Process Cases for the PMDA for regionally specific sections and fields on the Case page.

Section Name Description
Details Captures the basic Case details including the case identifier, report source, seriousness, and version information.
Device Details Captures the basic device-type Case details, including the device report type and whether the Case is a malfunction-only report.
Timeline Displays a visual and interactive Medical Review Timeline, including the time and duration of adverse events, product usage, dosage regimens, test results, drug history, and medical history.
This Case is Locked

Appears when a Case is locked, which prevents making changes.

This section appears only if configured by your Admin.
Contacts Captures information about the case contacts.
Patient Captures patient information, including a name or identifier, age, sex, height, weight, and medical record numbers (MRN).
Pregnancy Information Captures information about the pregnancy and outcome of Cases tracking a pregnancy.
Child Information Captures information about infants born from tracked pregnancy Cases, when there were no adverse events in the infant.
Products Captures products that the patient was taking at the time the adverse event occurred, including the primary Case Product and any suspect, concomitant, interactive, and treatment products, as well as drugs that were not administered but that may be suspect.
This section appears as Products (Study) for Cases linked to a Study.
Adverse Events Captures adverse events, including the primary adverse event and any secondary adverse events.
Diagnoses Captures case diagnoses for signs and symptoms that were reported.
Assessments Captures Assessments that link Adverse Events with Products.
Assessment Results Captures Assessment Results that assess the causality between Adverse Events and Products.
Expectedness Captures the Expectedness of Adverse Events for Products using Core and Local Datasheets.
Causes of Death

Captures the patient's cause of death, including autopsy-determined and reported causes of death.

This section appears only when an adverse event results in death.
Medical History & Concurrent Conditions Captures events in the patient's medical history.
Drug History Captures the patient's drug history.
Test Results Captures test results for the patient's lab tests.
Narrative Captures the Case narrative, reporter's comments, and company comments. The narrative document is automatically generated when you open a Case.
Study Captures information about the study the Case is under, if applicable.
This section appears in Cases linked to a Study.
Study Registrations Captures study registrations for the selected study.
This section appears in Study Cases only.
Linked Cases Captures case relationships for linking the Case to related Cases in Vault Safety.
Reference Numbers Captures case identifiers tracked by organizations and systems outside of Vault Safety.
Documents Captures the supporting and source documentation linked to the Case, including the Case narrative.
Submissions & Distributions Captures Transmission object records for any Case submissions or distributions.
Workflow Timelines Captures a timeline of workflow actions and tasks and the details of each. Learn more about Using Object Workflows
Signatures Captures electronic signatures that are collected for workflow actions requiring signatures. Learn more about Managing Object eSignatures.
System Captures information about the Case from a system level.

Types of Fields

Text Fields

Text fields accept any combination of text and numeric values and special characters. Select or tab into a text field and type to enter a value.

Number Fields

Number fields accept numeric characters 0 through 9, a period (.), and a dash (-). Select or tab into a number field and type to enter a value.

Checkboxes

Checkboxes are a quick way to enable or disable options. Select a checkbox to enable an option, clear a checkbox to disable an option.

Picklists

Picklist fields have a predefined set of values you can choose from. When you select or tab into a picklist field, a list drops down and displays the available values. To enter a value, select it from the list.

Codelists

Like picklists, codelists have a predefined list of values you can choose from. Each value corresponds to a structured data standard, such as ISO, UCUM, and ICH-M2.

When you select or tab into a codelist field, a list drops down and displays some or all the available values. To instantly filter the codelist, start typing a value or keyword or select the Advanced Search (Binoculars Icon) icon to access the search window.

Date and Time

Date and time fields accept values in the following format:

YYYY/MM/DD HH:MM {AM | PM} {Timezone}

For date and time fields, specify the value to the level of precision that you have available. For example, you can specify only the year the event occurred or as precise to the exact minute the event occurred.

Select or tab into a date and time field, and then type the date and time or select it using the calendar. If you need to change the year in the calendar, click the year in the header and select a different year. Enter the hour in the 12-hour format, followed by the minute (if available), and timezone.

ISO-8601 (idate) Date and Time Format

Vault Safety supports partial (imprecise) date specification in accordance with ISO-8601 standard formatting. The system includes idate text fields that can represent date precision to the year, month, day, hour, minute, or second, and includes the option for GMT offsets. This is compliant with E2B submissions that allow for imprecise dates in this format.

Controlled Vocabulary

Vault Safety supports the ICH Controlled Vocabularies for Drug Safety and E2B data transmission.

Units of Measurement

Vault Safety supports E2B(R3) units of measurement for dose, strength, and time intervals, including support for the Unified Code of Units of Measure (UCUM) and the constrained UCUM. Users can also make custom entries for dose, strength, and test result unit fields.

Routes of Administration

Vault Safety supports the E2B(R3) data entry standard and custom entries for route of administration terms. You can enter the route of administration as text or as a code from the E2B(R2) dictionary.

xEVMPD

Vault Safety supports a selection of dose forms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD).

Reason Omitted (nullFlavors)

While personal data and personally identifiable information (PII) is required for effective safety data analysis, you may be unable to enter certain information on the Case page due to privacy, security, or other reasons.

You can omit values for some fields on the Case page and specify the rationale using the Reason Omitted field. The Reason Omitted field is a codelist with the following default options:

  • No Information
  • Masked
  • Unknown
  • Not Applicable
  • Asked But Unknown
  • Not Asked
  • Negative Infinity
  • Positive Infinity
  • Other

With the exception of Medical History Text, the Reasons Omitted codelist aligns with the ICH E2B(R3), EMA E2B(R3), and FDA VAERS E2B(R3) code formats for nullFlavors.

To support compliant E2B submissions, Vault Safety includes a Medical History Text control-type field with the Reason Omitted field filtered to the following valid options:

  • Not Asked
  • Unknown
  • Masked
  • Asked But Unknown

For more information on this field, see Update the Case Layout for Reasons Omitted for Medical History Text.

Configure Reasons Omitted provides more information about managing Reasons Omitted options.