Adverse Event Reports

This page displays the list of adverse event reports (AER) related to the complaint. You can also create more AERs on this page.

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access this page:

This topic describes:

This page discusses:

See Also
Adverse Event Report Properties

Columns

Column Name Description
Name Name of AER

: a file is attached

Click to view the details of the attached file and download it.
AER Type Type of AER. Possible values are CMDR, MDR, MDV, and PMDA.
ClassificationAER classification based on type
StatusState of the AER. Possible states are Create, Review, Submission Approval, Submitted, Complete, and Waived.
Type of ReportType of report. Possible values are Initial, Follow-up, Final, and Initial and Final.

: AER is not due. Appears only when the AER is in Create or Review state.

: AER is due. Appears only when the AER is in Create or Review state

: AER is waived. Appears only when the AER is in Waived state

Blank: AER is in Submission Approval, Submitted, or Complete state.

Event NameName of derived event for which AER is created. Click to view the details of the derived event.
Product ModelName of product model associated with the derived event. Click to view the details of the product model.
ReviewedDate on which AER was reviewed
SubmittedDate on which AER was submitted
Report DueDate by which AER must be submitted
Regulatory ResponseResponse obtained from the regulatory body

Actions and Toolbar Commands

Action DescriptionFor More Information
Create New Creates a new AERCreating Adverse Event Reports
Create Follow-up Creates follow-up of the selected AER.
Note: Check for the these:
  • The selected AER must be in Submitted state.
  • AER must not be final report
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Submit eMDR/Follow Up Submits AER to FDA. Click OK to confirm.
Notes: Check for the these:
  • You can perform this action only for AERs of type MDR.
  • You can submit only the latest version of the MDR.
  • The selected MDR must be in the Submission Approval state.
  • You can submit only the MDRs that you own.
  • An XML file is created and located in the eMDR Files tab on the Files page. You can download this file and send to the FDA.
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WaiveWaives an AERWaiving an AER
Un-WaiveRemoves AER waiver and returns the AER to Create state--
DeleteDeletes the selected AER. Click OK to confirm.
Note: You can delete only the AERs that are in Create state.
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Edit AllLets you modify AER due dateModify AER Due Date

Categories

Category Name DescriptionFor More Information
Complaint PropertiesLists the details of the complaintComplaint Properties
ContactsLists contacts associated with the complaintContacts Page
CorrespondencesLists correspondence associated with the complaintCorrespondence List
Product EvaluationLists evaluation associated with the complaintProduct Evaluations
Reference DocumentsLists documents related to the complaintSee Managing Documents in the Business Process Services - Common User's Guide
DiscussionsLists discussions related to the complaintSee Working with Discussions in the Business Process Services - Common User's Guide
LifecycleDisplays the lifecycle of the complaint

About complaint lifecycle, see Content Lifecycles

Related ItemsLists objects related to the complaintSee Related Items List.
HistoryDisplays complaint historySee 3DEXPERIENCE Basics | Web Apps Common Services | User Interface | Viewing History for Content.
Where UsedLists complaint usageSee Where Used/Related Page in the Business Process Services - Common User's Guide
Related CAPAShows related CAPA projects and CAPA requests.See Related CAPA Page.