Properties
Fields
| Section Name | Field Name | Description |
|---|---|---|
| Name | Name of the AER | |
| AER Type | Type of AER. Possible values are CMDR, MDR, MDV, and PMDA. | |
| Classification | Classification of AER based on type | |
| Final | TRUE: AER is final FALSE: AER is not final | |
| Owner | Name of AER owner | |
| Reviewer | Name of AER reviewer | |
| Reviewed Date | Date on which AER was reviewed | |
| Report Submitter | Name of person who submitted AER | |
| Submitted Date | Date on which AER was submitted | |
| Regulatory Response | Response obtained from regulatory body | |
| Dates | Report Due | Date on which AER is due |
| Waiver Rationale | Reason provided to waive the AER | |
| Message Id | Message ID obtained from FDA acknowledgement Note:
This field is available only for AERs of type MDR.
| |
| Core Id | Core ID obtained from FDA acknowledgement Note:
This field is available only for AERs of type MDR.
|
Actions and Toolbar Commands
| Action | Description | For More Information |
|---|---|---|
| Send to Review | Promotes the AER to Review state. This action is available only when the AER is in Create state. | -- |
| Send to Submission Approval | Promotes the AER from Review to Submission Approval state. This action is available only when the AER is in Review state and if no route object exists between Review and Submission Approval states. | -- |
| Send to Complete | Promotes a submitted AER to Complete state. This action is available only when the AER is in Submitted state. | -- |
| Regenerate File | Regenerates the AER file and attaches it to the AER. This action is available only when the AER is in Create state. | |
| Waive | Waives the AER. This action is available only when the AER is in Create, Review, Submission Approval, Submitted, and Complete states. | Waiving an AER |
| Edit | Lets you modify the details of the AER | Modifying AER Details |