AER Field Reference

(Required) This field designates the sponsor Organization.

Select the sponsor Organization. If your account is affiliated with only one Organization in your Vault, Vault populates this field automatically.

(Required) The date the event was first reported. This date starts the regulatory clock in calculating expedited reporting (for example, 7-day or 15-day reports).

Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. The time is optional.

The latest date when additional information was received about the case.

Use the calendar to select the date or enter the date manually. You must specify the year, month, and day at a minimum. Time is optional.

There can be only one New Info Date per Case version. If you overwrite this field with a new date, any previously recorded New Info Dates will appear in the audit trail.

(Required) The method in which the adverse event was reported by the primary source.

Select the appropriate report type.

The Study associated with the report. Depending on your Vault's configuration, this field may be hidden when the Report Type field is not set to Study.

Select the Study.

Upon Case promotion, Vault snapshots the preconfigured information from the Study library to populate details from this Study on the Case, including the Study Registration, Products, Dosage, and Indication.

See Manage Studies for more information.

The type of study for which the product was administered. Depending on your Vault's configuration, this field may only appear when the Report Type is Study.

If this field is preconfigured in the associated Study, Vault automatically populates this field when you promote to Case. Otherwise, you can manually select the value.

The following options are available, but your Vault may be configured with additional options:

• Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
• Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
• Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.

The worldwide unique case identification (WWUID) number for an external safety case. For example, a previously submitted case received from an MAH or partner.

If the Case is imported from an E2B file that contains a worldwide UID (A.1.10.1/C.1.8.1), this field value is imported from the E2B file. Otherwise, you can enter the value manually for external cases. If left blank, Vault automatically populates the field upon Case promotion using the Organization/Sponsor UID Code.

The source document for the report. Use the link in this field to navigate to the source document.

Vault populates this field automatically when a document is used to create the Case. Otherwise, you can select the document manually.

The version of the source document. Use the link in this field to navigate to the source document.

Vault populates this field when you attach or create the Case from a source file.

This field indicates whether the report has an identifiable product or study. The value must be Yes to promote the AER to a Case.

When you save the AER, Vault populates this field with Yes or No, depending on whether the AER has enough data to identify a product or study.

This field indicates whether the report has an identifiable event. The value must be Yes to promote the AER to a Case.

When you save the AER, Vault populates this field with Yes or No, depending on whether the AER has enough data to identify an event.

This field indicates whether the report has an identifiable country. The value must be Yes to promote the AER Report to a Case.

When you save the AER, Vault populates this field with Yes or No, depending on whether the AER has enough data to identify an event country or reporter country.

This field indicates whether the report has an identifiable patient. The value must be Yes to promote the AER to a Case.

When you save the AER, Vault populates this field with Yes or No, depending on whether the AER has enough data to identify a patient.

This field indicates whether the report has an identifiable reporter. The value must be Yes to promote the AER to a Case.

When you save the AER, Vault populates this field with Yes or No, depending on whether the AER has enough data to identify a reporter.

This field indicates whether the AER was imported from an E2B file.

This field is system managed and automatically populated.

In the standard Vault Safety template, the Report Type must be set to Study for this field to appear.

Select the appropriate Study Site from the list. An Admin must have previously configured a Study Site for it to appear in this list. See Manage Studies for more information about adding Study Sites.

In the standard Vault Safety template, the Report Type must be set to Study for this field to appear.

Select a Study Contact from the chosen Study Site. Once you promote the AER to a Case, Vault creates the primary Reporter using the selected Site Reporter and Study Site. See Manage Studies for more information about adding Study Contacts.

The Reporter's qualification.

Start typing for instant search or select the binoculars icon browse the available options.

Upon Case promotion, Vault populates the HCP Confirmed field on the Case Adverse Event, based on the qualification of the reporting source specified in this field.

If you select Patient in this field, the Patient is considered the primary Reporter and when you promote the AER to a Case, the Patient name fields are copied to the primary Reporter Case Contact.

The country where the primary Reporter resides.

Start typing for instant search or select the binoculars icon browse the available options.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

This field does not appear if the Reporter Qualification is Patient.

Enter the Reporter's first name.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

This field does not appear if the Reporter Qualification is Patient.

Enter the Reporter's last name.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Indicates whether the Reporter has consented to receive emails.

Select this field if the contact has consented to receiving email notifications or requests for follow-up information. See Send a Follow-Up Email Questionnaire to a Case Reporter for more information.

Indicates the Reporter's assessment on the adverse event causality in relation to the primary product. This field does not appear if the Reporter Qualification is Patient.

Select the appropriate option from the list. If the adverse event is serious and you specify this field, Vault snapshots this field to the Reporter's Case Assessment Result for the primary Product and SAE upon Case promotion. See Perform Medical Review for more information about Case Assessments.

Enter the patient's initials.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's name prefix or title. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's first name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's middle name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Enter the patient's last name. This field is used in FDA VAERS reporting.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The unique Subject/Patient ID, Centre ID, or random number in a clinical trial.

If a clinical trial investigated the adverse event, enter the following information:

• The patient's medical record number with a general practitioner
• The general practitioner's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

Select the patient's gender.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's birth date.

Use the Calendar pop-up tool to select a date or enter the date manually. For this field to be exported to E2B Transmissions, the full date is required with year, month, and day.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's age at the onset of the adverse event.

Vault automatically calculates this field upon Case promotion. If you manually enter a value, and Vault later auto-calculates this field, the field is overwritten by the auto-calculated value.

Auto-Calculation

When you promote to Case, Vault automatically calculates this field using the time interval between the following dates:

1. The Case Date of Birth
2. The Case Adverse Event Event Onset. If an Event Onset is not available, Vault uses the Case Receipt Date.

When only partial dates are available, the system calculates the age using the first day in the month or year entered. For example, if only "2021" is entered, the date 1/1/2021 is used.

Vault automatically calculates this field upon Case promotion or when the Age at Onset field on the Case is updated. If you manually enter a value, and Vault later recalculates this field, the field is overwritten by the auto-calculated value.

Auto-Calculation

Vault automatically calculates the age group based on the value in the Age at Onset field and the above criteria.

The patient's age at the time of being administered the primary vaccine-type product. This field is used in FDA VAERS reporting.

When you promote to Case, Vault automatically calculates this field upon Case promotion or when the Case is updated. If you manually enter a value, and Vault later auto-calculates this field, the field is overwritten by the auto-calculated value.

Auto-Calculation

1. The Case Date of Birth
2. The primary Vaccine-type Case Product Dosage First Admin Date

   If there are multiple Dosages under the primary Vaccine-type Case Product, Vault uses the earliest First Admin Date to calculate the age.

Enter the date when the patient was reported as deceased.

Use the Calendar pop-up tool to select a date or enter the date manually.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's medical record number with a specialist and the specialist's record number.

If the patient visited a specialist for the adverse event, enter the following information:

• The patient's medical record number with a specialist
• The specialist's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's medical record number with a hospital and the hospital's record number.

If the patient visited a hospital for the adverse event, enter the following information:

• The patient's medical record number with a hospital
• The hospital's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The patient's medical record number with a general practitioner and the general practitioner's record number.

If the patient visited a general practitioner for the adverse event, enter the following information:

• The patient's medical record number with a general practitioner
• The general practitioner's record number

You can enter multiple sets of record numbers in this field.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.

The product that is suspected to be associated with the adverse event. This field does not appear if the Report Type is Study.

When manually selecting the Product, this drop-down menu lists Products in the Product Library associated with the Organization selected on the AER. Once you select a product and save the page, this field links to the Product. See Manage Products for more information.

The Study Arm that the suspected product is associated with. This field only appears when the selected Study has Study Arms.

Select the Study Arm. Once you promote to Case, Vault automatically populates the Study Product and Product Dosage information based on the information pre-configured on the Study Arm. See Manage Studies for more information about managing Study Arms.

The Study Product that is suspected to be associated with the adverse event. This field does not appear if the Study selected on the AER is Blinded or has Study Arms.

When manually selecting the Study Product, this drop-down menu lists Study Products in the Product Library associated with the Study selected on the AER. Once you select a product and save the page, this field links to the Study Product. See Manage Studies for more information about adding Study Products.

The reason the patient was administered the Study Product. Depending on your Vault's configuration, this field may be hidden when the Report Type field is not set to Study.

If this field is preconfigured in the associated Study, Vault automatically populates this field when you promote to Case. Otherwise, you can manually select the value.

The following options are available, but your Vault may be configured with additional options:

• Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
• Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
• Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.

This field does not appear on layouts by default and must be added by your Admin.

Description of the medical event, as reported by the primary source.

Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser. See Code MedDRA Terms for more information.

The level of impact the adverse event had on the patient. You can enter multiple values in this field.

Select one or more seriousness criteria to describe the level of impact the adverse event had on the patient. If the event is not serious, do not select a value in this field.

The date on which the adverse event or reaction started.

Use the Calendar pop-up tool to select a date or enter the date manually.

If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.