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Set alerts for file expiration

Setting up file expiration alerts helps inform users via email when documents or files related to a clinical trial are nearing their expiration date or have already expired. This feature plays a critical role in the management of trial documentation and compliance.

Important

Note that you cannot set expiration alerts for replaced files and files with the Dropped status.

There are three types of default alert recipients:

  • File Owner: the user who uploaded the file.

  • File Approver: the user who approved or signed the file.

  • eTMF Administrator: the user who is assigned as the eTMF administrator in the ADMIN application.

The eTMF administrators will receive the email according to accesses granted to them via the ADMIN application, as described in the following table.

File level/Access level

Study check_yes.png

Site minus_no.png

Study check_yes.png

Site check_yes.png

Study minus_no.png

Site minus_no.png

Study-level file

check_yes.png

check_yes.png

minus_no.png

Country-level file

check_yes.png

check_yes.png

minus_no.png

Site-level file

minus_no.png

check_yes.png

minus_no.png

Additionally, you can set up specific email addresses to receive notification alerts on file expiration for:

  • The study level

  • The country level and specific countries

  • The site level and specific sites

To set the alert triggers

  1. In the eTMF application header, select the TMF tab.

  2. On the page that opens, in the left pane, select the Study List subtab.

  3. On the Study list table that appears, go to the required study. Then next to this study, select More more_icon.png > File Expired Alerts File_expired_alerts_icon.png.

    Accessing option to set alerts
    Figure 1. Accessing option to set alerts

  4. On the page that opens, select the checkbox of the needed recipient type. In the table, go to the target level of an email recipient and in Action(s) column, select Edit pencil_icon.png next to it.

    Selecting target level of email recipient
    Figure 2. Selecting target level of email recipient

  5. In the Set Email Address dialog that appears, enter the recipient's email address and select confirm_button.png.

    Setting email address
    Figure 3. Setting email address

  6. Select save_button_red.png to save the implemented changes.

Upon saving, the set recipients start receiving notifications on the expired files in their emails.

In this section:

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.