Files

This page lists Adverse Event Report (AER) files in three tabs. The Files tab contains the .pdf file created automatically when the AER is created. The eMDR Files tab lists the generated .xml files which you can download and send to the regulatory body. The eMDR Acknowledgements tab lists acknowledgement files that are received from the regulatory body.

Important: This app creates reports or generates content that contains personal data. Manage these in accordance with good personal data treatment practices.

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Files

Columns

Column Name Description

: file is locked

File NameName of the file. Click to view the details of the AER. You can download this file, print it, and send to regulatory authority by mail.
VerVersion of the file. Click to view all versions.
OriginatedDate on which file was created
CommentsAdditional information
OriginatorName of person who created the AER
FormatFormat of the file
File SizeSize of file in bytes
ActionsAvailable actions are view, download, checkout, lock, and unlock. For more information, see Files Associated with an Object.

Actions

Action DescriptionFor More Information
Upload/CheckinCopies an existing or new file from your local machine and checks it into document object. If you check in an existing file, a new version of that file is created. Uploading Files
DownloadCopies selected files to your local machine without locking them; you can select all the files and they are downloaded in a single zip file.--
CheckoutCopies files to your local machine and locks them on the server.--
Delete This VersionFor a versioning document, deletes only the current version of the selected file. Click OK to confirm.--
Delete All VersionsFor a versioning document, deletes all versions of the selected file. Click OK to confirm.--

eMDR Files

Columns

Column Name Description
File NameName of the file. Click to view the details of the AER. You can download this file and send to regulatory authority by web trader.
OriginatedDate on which file was created
FormatFormat of the file
File SizeSize of file in bytes
ActionsAvailable actions are view and download. For more information, see Files Associated with an Object.

eMDR Acknowledgements

Columns

Column Name Description
File NameName of the acknowledgement file. Click to view the details.
OriginatedDate on which file was created
ActionsAvailable actions are View, Check-in ACKs, and Download. For more information, see Files Associated with an Object.

A Regulatory Lead can check-in acknowledgement files in to an MDR using the Check-in ACKs command. The file names must not contain special characters such as #,$,@, %,and &. The acknowledgement file must have the information such as message id, core id, status, and regulatory response.

Categories

Category Name DescriptionFor More Information
PropertiesDisplays the details of the AERProperties
ContactsLists contacts associated with the AERContacts Page
CountriesLists countries associated with the AERCountries Page
Follow-upLists revisions created for the AERFollow-up
LifecycleDisplays the lifecycle of the AER

About AER lifecycle, see Content Lifecycles

About lifecycles, see 3DEXPERIENCE Advanced Services | Web Apps Common Services: Lifecycles

HistoryDisplays AER historySee 3DEXPERIENCE Basics | Web Apps Common Services | User Interface | Viewing History for Content .
Where UsedLists AER usageSee Where Used/Related Page in the Business Process Services - Common User's Guide