To report an adverse event:

  1. Go to Sites > [Site Name].
  2. Click  icon in the actions column of the subject you want to register an adverse event for.
  3. Fill out relevant fields in the form.
  4. Click Save report.

To edit an adverse event report:

  1. Go to AE/SAE Reports.
  2. View the report and click Edit report. This will activate editing mode.

  3. Make changes to the form and click Save report.

To sign an AE/SAE report:

  1. Go to AE/SAE Reports.
  2. View the report you wish to sign.
  3. Click Sign report and fill out information required.

  4. Click Save and sign report. For security reasons, you will be asked to re-enter your password.

Amend AE/SAE report

If the report has been signed and and followed up it is possible to amend it, allowing most fields to be changed. The changes and reason for changes are logged in a change log, that is visible to anyone visiting the form afterwards.

  1. Click on Amend Report
  2. Perform the desired changes
  3. Press Save Amendment
  4. Input reason for changes
  5. Press continue
  6. Input password for security reasons

The changes can now be seen in the change log.

Note: To amend investigator fields, you must have "Investigator AE". Likewise if you wish to amend sponsor fields, you must have the "Sponsor AE" in addition to the permission "Amend (S)AE"

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