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Amendments

You should submit all amendments and other post approval requirements onÌý.ÌýThe Principal InvestigatorÌýmust obtain HREC approval for all amendmentsÌýpriorÌýto implementation. Failure to do so risks researchers' legal indemnity, right to publication and opportunity to seek future funding.

An amendment can include changes to the:

• protocol, including recruitment strategies or data collection
• investigator brochureÌý
• PICFs andÌýother participant material such as letters, advertisements, questionnaires
• study team, such as the addition or removal of new Principal Investigators and associate investigators.ÌýYou do not need to notify usÌýabout other study team members. However you must keep your studyÌýÌýup to date for auditing purposes
• participating sites, such as the addition of new sites