AUS Adverse Event and Special Situation Follow Up Information Request Form 

 

Instructions:

This form is to be used by Roche Products Pty Limited (Roche) Drug Safety in place of SRD-0120176 for requesting missing and/or follow-up information for reports of Adverse Events (AEs) and Special Situations originating from a spontaneous source, a Non-Interventional Study (NIS), a Market Research and Patient support program (MAP), a Pre-Approval Access (PAA) / Compassionate Use (CU) Program and a Post-Trial Access Program (PTAP).

 

The four essential elements for AE/Special Situations reporting are marked with *.

Once completed, forward the form to the Roche Drug Safety email address: [email protected]

 

*Note: Hereafter, AEs and Special Situations will be collectively referred to as "adverse events".

*Note: The format or wording of this form may be modified by the Roche Drug Safetyas needed as long as the requirement on essential data that needsto be collected is not omitted.

 

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