eProtocol

Creating safety submissions

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Creating safety submissions

Creating an adverse event/safety report form

Home> Approved applications> Application ID> Start adverse event/safety report form

A pop-up window will open. Within this window select ‘adverse event/safety reporting’ and click OK

If an adverse event/safety report form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

On the form select either:

  1. Individual Event

OR

  1. Summary Report

For an Individual Event, select section 1 and complete the report as required. Ensure that all questions are answered including the details of the event and attach relevant documents.

For Summary reporting, select 2 and attach relevant documents.

Once completed click SUBMIT FORM

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