1. User's Guide
  2. Manage your periodic report submissions
  3. Prepare content for periodic reports
  4. Prepare content for an ICH PSUR
  5. Create Periodic Safety Update Reports (PSURs)

Create Periodic Safety Update Reports (PSURs)

  1. Select Reports, then select Periodic, and click ICH PSUR Reports. A list of PSUR Reports opens in the right frame.
  2. Click Copy or Modify to create a new report from an existing report.

    OR

    Click New Report to create an entirely new report.

  3. When the system opens the ICH PSUR Line Listing Reports dialog box, enter an appropriate report name in the Report Name field.

    Use the tabs to configure the PSUR.

Parent topic: Prepare content for an ICH PSUR