The records and fields on the Case page simplify entering Case details into Vault.
Default Case Pages
The following table describes the default pages on Cases. Depending on your configuration, some or all of these pages and the sections within them may appear. In addition, some sections appear only after a Case reaches a certain lifecycle state.
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.
| Page Name | Description |
|---|---|
| General | Captures the basic Case details including information about follow-ups, tags, report type, and case identifiers. |
| Study | For study Cases, captures details about the Studies and Study Registrations associated with reports. |
| Case | Captures details about the patient, case contacts, products, and adverse events. |
| Patient | Captures details about a patient's family, drug history, medical history, test results, cause of death, and diagnoses. |
| Assessment | Captures details about the medical timeline, narrative, and medical assessments. |
| Activities | Captures details about conformance validations, checklists, action items, and transmissions. |
| References | Captures information about applicable Localized Cases, related Cases, documents, and system information about the Case. |
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 (
) 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 supports partial (imprecise) date specification in accordance with ISO-8601 standard formatting. Vault 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 supports the ICH Controlled Vocabularies for Drug Safety and E2B data transmission.
Units of Measurement
Vault 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 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.
Dose Forms
Vault supports a selection of dose forms, including terms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) and the Medicines and Healthcare products Regulatory Agency (MHRA). You can also create custom Custom Dose Forms, Routes of Administration, and Units of Measurement. Encoded dose forms in imported E2B reports map to these dictionary entries.
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 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.
Note: All appropriate security measures should be taken to protect a patient’s private personal data during Case data entry and processing. Ensure that you follow your company’s policies and procedures regarding data protection and privacy.