AER Field Reference

Enter the primary information about the adverse event in an AER.

Sections in This Article

Enter Report Details

Use the Details section to specify general information about the adverse event.

details-page
Details Section
Field Description
Organization (Required) This field designates the sponsor Organization.
Select the sponsor Organization. If your account is affiliated with only one Organization in your vault, the system populates this field automatically.
Receipt Date (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. You must specify the year, month, and day at a minimum. The time is optional.
New Info Date 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.

If you leave this field blank, the system automatically populates the date entered in the Receipt Date field once you save the page.

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.

Report Type (Required) The method in which the adverse event was reported by the primary source.
Select the appropriate report type.
Study 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, the system 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.

To learn more, see Manage Studies.
Study Type 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, the system automatically populates this field when you promote to Case. Otherwise, you can manually select the value.

The following options are available by default:

  • 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.
Worldwide UID 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, the system automatically populates the field upon Case promotion using the Organization/Sponsor UID Code.
Source Document The source document for the report. Use the link in this field to navigate to the source document.
The system populates this field automatically when a document is used to create the Case. Otherwise, you can select the document manually.
Version The version of the source document. Use the link in this field to navigate to the source document.
The system populates this field when you attach or create the Case from a source file.
Identifiable Company Product 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, the system populates this field with Yes or No, depending on whether the AER has enough data to identify a product or study.
Identifiable Reported Event 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, the system populates this field with Yes or No, depending on whether the AER has enough data to identify an event.
Identifiable Country 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, the system populates this field with Yes or No, depending on whether the AER has enough data to identify an event country or reporter country.
Identifiable Patient 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, the system populates this field with Yes or No, depending on whether the AER has enough data to identify a patient.
Identifiable Reporter 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, the system populates this field with Yes or No, depending on whether the AER has enough data to identify a reporter.
E2B Import This field indicates whether the AER was imported from an E2B file.
This field is system managed and automatically populated.
Follow-Up Rule
Select the Follow-Up Rule for the questionnaires with which the system should attempt to match the Case or AER. If you leave this field blank and select Send Follow-Up, the system uses Invalid Case (Missing Parameters) as the default value.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
This field does not appear on page layouts by default and must be added by an administrator to appear.
Send Follow-Up
Select this field to trigger the system to evaluate whether this Case or AER matches the criteria for one or more questionnaires. After running the process to generate questionnaires, the system clears this field.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
This field does not appear on page layouts by default and must be added by an administrator to appear.

Enter Reporter Information

Use the Reporter section to enter information about the reporting sources.

The following images show the Reporter section:

  • reporter-page
    Reporter Section without Pre-Configured Study Site and Site Reporter
  • reporter-page
    Reporter Section with Pre-Configured Study Site and Site Reporter
Field Description
Study Site 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 administrator must have previously configured a Study Site for it to appear in this list.
To learn more, see Add a Study Site.
Site Reporter 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, the system creates the primary Reporter using the selected Site Reporter and Study Site.
To learn more, see Manage Study Contacts.
Reporter Qualification The Reporter's qualification.

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

Upon Case promotion, the system 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.

Reporter Country 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.
Reporter First Name 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.
Reporter Last Name 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.
Reporter Email Address
Enter the Reporter's email address.
To learn more, see Send a Follow-Up Email Questionnaire to a Case Reporter.
Reporter Assessment Result 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, the system snapshots this field to the Reporter's Case Assessment Result for the primary Product and SAE upon Case promotion.
To learn more, see Case Assessments.
Reporter's Comments
Enter the Reporter's comments on the diagnosis, causality assessment, or other relevant issues.

Note When an imported AER is promoted to a Case, the Email Address and Email Consent Provided fields are not copied over to the promoted Case.

Enter Patient Information

Use the Patient section to specify information about the patient.

patient-page
Patient Section
Field Description
Patient Initials
Enter the patient's initials.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Patient Name Prefix
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.
Patient First Name
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.
Patient Middle Name
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.
Patient Last Name
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.
Investigation MRN 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.
Gender
Select the patient's gender.
If the source report omits this information, use the Reason Omitted field to describe why the information is unavailable.
Date of Birth 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.
Age at Onset The patient's age at the onset of the adverse event.
The system automatically calculates this field upon Case promotion. If you manually enter a value, and the system later auto-calculates this field, the field is overwritten by the auto-calculated value.
Auto-Calculation

When you promote to Case, the system 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, the system 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.

Age Group The patient's age group at the onset of the adverse event, according to the following criteria:
Age Group Age at Onset
Fetus 0 weeks/days/hours/minutes old
Neonate More than 0 to less than 4 weeks old
Infant 4 weeks to less than 12 months old
Child 1 year to less than 12 years old
Adolescent 12 years to less than 18 years old
Adult 18 years to less than 65 years old
Elderly 65 years and older
The system 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 the system later recalculates this field, the field is overwritten by the auto-calculated value.
Auto-Calculation
The system automatically calculates the age group based on the value in the Age at Onset field and the above criteria.
Age at Vaccination 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, the system automatically calculates this field upon Case promotion or when the Case is updated. If you manually enter a value, and the system later auto-calculates this field, the field is overwritten by the auto-calculated value.
Auto-Calculation

The system automatically calculates this field when the primary Case Product is a Vaccine-type product. The age at vaccination is calculated using the time interval between the following dates:

  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, the system uses the earliest First Admin Date to calculate the age.

Note Both date fields must be precise to at least the day to be used for auto-calculation.

Date of Death 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.
Specialist MRN 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.
Hospital MRN 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.
GP MRN 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.

Enter Primary Product Information

Use the Product section to specify information about the product that is suspected to be associated with the adverse event.

The fields that appear under the Product section depend on whether the Report Type field is set to Study, whether the selected Study is Blinded, and whether the selected Study has Study Arms.

Note If there are multiple products suspected to be associated with the adverse event, specify the most likely association. You can add additional products when the Adverse Event Report is promoted to a Case.

The following images show the AER Product section in the standard Vault Safety template configuration:

  • product-page-1
    Product (Non-Study Case)
  • product-page-2
    Open Label or Single Blinded Study Product (Study Case)
  • product-page-4
    Double Blinded Study with Study (Study Case)
Field Description
Product 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.
To learn more, see Manage Products.
Study Arm 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, the system automatically populates the Study Product and Product Dosage information based on the information pre-configured on the Study Arm.
To learn more, see Manage Study Arms.
Study Product 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.
To learn more, see Add a Study Product.
Study Blinded
This field is automatically populated with Yes or No depending on whether the Study selected on the AER is blinded.
To learn more, see Manage Studies.
Study Type 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, the system 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 page layouts by default and must be added by an administrator to appear.

Enter Primary Adverse Event

Use the Adverse Event section to specify information about the primary adverse event that occurred.

adverse-event-section
Adverse Event Section
Field Description
Event 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.
To learn more, see Code MedDRA Terms.
Event Country
Select the country where the adverse event occurred.
Seriousness 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.
Onset 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.

Enter Medical History

Use the Medical History section to specify the patient’s medical history. Once the AER is promoted to a Case, you can use MedDRA to code the Case Medical History.

medical-history-section
Medical History Section
Field Description
Medical History Text
Enter the medical history and concurrent conditions for the patient, not including the adverse reaction or event.
Medical History Text (reason omitted)
If the source report omits the medical history, select the option that describes why this information is not available.

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