Email and in-application notifications

Notify sponsor and site users about the status of their archive and report requests, ensuring they complete related follow-up activities like downloading and confirming requests and reports.

Email and in-application notifications can be customized to notify Sponsor and Site users about the status of PDF and report requests and inform Sponsor users about site-level PDF request, download, and confirmation activities. The system can even notify sponsor users if the storage limit is reaching capacity. For more information about viewing in-application notifications, see View notifications.

Modes

This feature is available in Testing and Production modes only.

Required permissions

Users belonging to a study role that includes the Manage Archives Settings permission can access the Archives Settings tab under Study Settings to do the following.

• Define the Default Email address.
• Enable and disable each notification.

  Note:

  The Storage limit has exceeded notification cannot be disabled.
• Determine the recipients for each notification.
• Customize the default notification body text.

Notification name, details, and required permissions

Review the table below to familiarize yourself with each notification.

Table 4-1 Notification name, details, and required permissions

Notification name	Notification details	Required permissions to receive the notification
Request available for download	Sponsor and site users receive this notification when a request they generated is ready for download. Site users receive this notification when a request generated by a sponsor user and shared with sites is ready for download.	For site users Run Archival PDFs for your site(s) (Site) Download Archival PDFs and Audit Reports (Site) For sponsor users Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request failure	Sponsor and site users receive this notification when a request they generated has failed to complete successfully.	Run Archival PDFs for your site(s) (Site) Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request submitted by site user	Sponsor users receive this notification when a site user generates a request for a site to which they are both assigned.	Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
Request shared with site downloaded	The sponsor user who generated the request receives this notification when a request shared with a site has been downloaded by the site.	Run and download Site Confirmation and Download Log audit reports
Request confirmed by site	The sponsor user who generated the request receives this notification when a request shared with a site has been confirmed by the site.	Run and download Site Confirmation and Download Log audit reports
Storage limit has exceeded	All sponsor users assigned to the study where a request surpasses the 75% storage threshold receives this notification. Note: Oracle allocates 1000 GB of storage server space for each customer, which is shared across all studies.	N/A Sponsor users with access to Oracle CRF Submit receive this notification.

Notification language details

Notifications are received in the system language (English, Chinese, or Japanese) defined for the person performing the action. See the table below for examples.

Table 4-2 Notification language detail examples

Notification name	Action and system language	Notification language
Request available for Download	A sponsor user, whose system language is English generates a request. A sponsor user, whose system language is English, generates a request and shares it with Japanese sites. A site user whose system language is Japanese generates a request.	The sponsor user receives the notification in English. The Japanese site users receive the notification in English. The site user receives the notification in Japanese.
Request failure	A sponsor or site user, whose system language is Japanese, generates a request that fails.	The user receives the notification in Japanese.
Request submitted by site user	A site user whose system language is Chinese generates a request.	The sponsor user receives the notification in Chinese.
Request shared with site downloaded	A site user, whose system language is Japanese, downloads a request that was generated and shared by a sponsor user, whose system language is English.	The sponsor user receives the notification in Japanese.
Request confirmed by site	A site user, whose system language is Chinese, confirms a request that was generated and shared by a sponsor user, whose system language is English.	The sponsor user receives the notification in Chinese.
Storage limit has exceeded	n/a	By default, sponsor users receive this notification in English.

Configure notifications and customize the notification body text

Here's how to enable a notification, define the default email address, determine the recipients, and customize the notification body text.

1. Start by opening the Study Settings.
2. Click on the Archives Settings tab.
3. Select the mode to work in (Production or Testing).
4. Enter a Default Email Address. This can be a single email address or a distribution list. Notifications are sent to this address when the Default Email option is selected as a recipient.

   Note:

   Default email recipients receive notifications in the system language (English, Chinese, or Japanese) defined for the user who performed the action.
5. Use the arrow to the left of each notification category (Request Status, Site Monitoring, and Miscellaneous) to expand the section to view the notifications.
6. Use the toggle to the left of each notification to enable and disable it. The toggle is blue when a notification is active.

   Note:

   The Storage limit has exceeded notification, under Miscellaneous, is enabled by default and cannot be disabled.
7. Use the arrow on the right side of an active notification to expand it. Then, select the recipients under the Send Notification to section.

   Note:

   In-application notifications are not created if Default Email is the only recipient selected.
8. Under the Notification Body section, click English, Chinese, or Japanese to view the notification text for that language. To customize the notification body text (for any language), click the pencil icon to the right of Code-list: <notification name>.

   Tip:

   You can paste the English text in the Chinese and Japanese Label cells if you want sponsor users to receive all notifications in English. If so, we recommend doing this for the Request submitted by site user, Request shared with site downloaded, and the Request confirmed by site notifications only.
9. You are taken to the Code List tab. Select ArchivesNotificationBody from Clinical One Default Code List.
10. Click the pencil icon in the upper-right corner.
11. Select one of the language tabs (English, Chinese, or Japanese). Then, click in any cell under the Label column to update the notification body text.

    Tip:

    Copy and paste the default text into a Word document or text file before making any changes. That way, you can restore the default text if needed.
12. Click Save.