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Frequently Asked Questions

Why does the Eye and Ear request information from the Sponsor?

The Eye and Ear may from time to time request additional information from the Sponsor to facilitate compliance with the NHMRC Guidelines

Extract from Safety monitoring and reporting in clinical trials involving therapeutic goods (NHMRC; 2016)

4. Responsibilities of the Institution
An institution’s responsibilities and oversight of safety information in clinical trials will differ
depending on whether they are hosting externally sponsored clinical trials or sponsoring locally
led non-commercial trials. In both cases they should help ensure that their site(s) understands and
complies with sponsor requirements. Institutions should have oversight of any issues that may require
management, such as disputes or litigation resulting from trials. Where the institution is also
named as the trial sponsor, the institution will also assume the sponsor responsibilities set
out in this document.
The Institution should:
a. assess whether any safety reports received impact on medico-legal risk, the responsible conduct
of research, adherence to contractual obligations or the trial’s continued site authorisation and,
where applicable, facilitate the implementation of corrective and preventative action
b. develop clear guidance for investigators detailing the requirements for safety reporting and
monitoring in clinical trials. This document(s) should cover the requirements for both externally
sponsored clinical trials and, if applicable, internally sponsored investigator/initiated or
collaborative group trials. 



Frequently asked questions will be added over time.


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Last updated 3 December 2019