Amendments

You should submit all amendments and other post approval requirements on Ethics Review Manager (ERM). The Principal Investigator must obtain HREC approval for all amendments prior to 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 brochure 
• PICFs and other participant material such as letters, advertisements, questionnaires
• study team, such as the addition or removal of new Principal Investigators and associate investigators. You do not need to notify us about other study team members. However you must keep your study delegation log up to date for auditing purposes
• participating sites, such as the addition of new sites