AE/SAE Reporting

To report an adverse event:

  1. Go to Sites > [Site Name].
  2. Click on the AESAE Reporting 1 icon in the actions column of the subject you want to register an adverse event for.

    AESAE Reporting 2
  3. Fill out relevant fields in the form.
  4. Click Save report.

To fill out & sign an AE/SAE report:

  1. Go to AE/SAE Reports.
  2. View the report you wish to fill out or sign.
  3. Click Fill Out and fill out the information required.
    AESAE Reporting 3
    AESAE Reporting 4
  4. You can always Save the report, regardless of completed data or not, but to Save and sign all data required for that particular step must be present.
  5. If the report has been saved with all data required for that step, there is a Sign button instead of a Fill Out, which will bring up the signature dialogue.

    AESAE Reporting 5

The action button (Fill out/ Save & Sign / Sign) will move along the AE report flow to show you what is next for the AE.

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.
    AESAE Reporting 6
    AESAE Reporting 7

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

Amend AE/SAE report

If the report has been signed 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 afterward.

  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.

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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