Creating Adverse Event Reports

You can create adverse event reports (AER) by using the decision tree or by providing specific information. You can answer questions in the decision tree to create AERs.

This task shows you how to:

Before you begin:
  • You must be a regulatory user.
  • The complaint must contain a reportable derived event.
See Also
Modifying AER Details
Waiving an AER

Create AER by using Decision Tree

You can answer questions in the decision tree and create AERs.

Before you begin: You must be on the Run Decision Tree page.
  1. From the Run Decision Tree page, in the Configure Questions tab toolbar, click Enable Edit.
  2. In the Response column, select the required answer for the corresponding question.
  3. Click Save.
    The answers are saved.
  4. Click Disable Edit to exit edit mode.
  5. In the Submit Response tab, verify your answers, and click Submit.
    AERs are created based on your answers.

You can view the created AERs in the Adverse Event Reports page.

Create AER Manually

You can create AERs manually by providing information such as type and classification.

Before you begin: You must be on the Adverse Event Reports page.
  1. From the Adverse Event Reports page toolbar, select Actions > Create New.
    The Create Adverse Event Report page appears.
  2. Enter the following details for each AER type you want to create.
    Section Name Field Name Description
    Event Select a derived event from the list.
    Product ModelSelect a product model.
    AERs TypeSelect the required AER types. You can select more than one.
    MDR

    This section appears when you select AER type as MDR

    		ClassificationSelect a classification. Available values are:
    • 5-Day
    • 30-Day
    CMDR

    This section appears when you select AER type as CMDR

    		ClassificationSelect a classification. Available values are:
    • 30-Day
    • 10-Day
    FinalSelect the check box if the report is final.
    Anticipated Date of final reportClick to select the required date.
    MDV

    This section appears when you select AER type as MDV

    		ClassificationSelect a classification. Available values are:
    • 30-Day
    • 10-Day
    FinalSelect the check box if the report is final.
    Report Sent To CountriesClick and select a country from the Search Results page.
    LanguageSelect AER language
    PMDA

    This section appears when you select AER type as PMDA

    		ClassificationSelect a classification. Available values are:
    • 30-Day
    • 15-Day
  3. Click Done.
    AERs are created for the selected types.

You can view the created AERs in the Adverse Event Reports page.