· web viewfor step by step instruction on how to submit amendments and safety notifications for...

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Amendment and Safety Notification Submissions – Ethics The HREC executive reviews all ethics amendment requests to approved projects. Please click here for the meeting submission deadlines and meeting dates. All ethics amendments and safety notifications are to be submitted through REGIS : REGIS recognises amendments and safety notifications as forms. Amendment forms include: General Amendments Ethics Approval Extension Requests Addition of site – CV to be uploaded into REGIS Change in PI/CPI The amendment form and supporting documentation must be submitted. These documents must be submitted in both clean and tracked copies with correct version numbers entered into REGIS. Please note the file name of the document uploaded must match original file name. Please ensure the completed NSLHD method of payment form for amendments is submitted into REGIS. Safety Notification forms include: Reporting Local Safety events to the Institution Serious Breach Notification Significant Safety Issue (SSI)

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Page 1:  · Web viewfor step by step instruction on how to submit amendments and safety notifications for ethics. Hard Copy Ethics submissions will not be processed by the Research Office

Amendment and Safety Notification Submissions – Ethics

The HREC executive reviews all ethics amendment requests to approved projects. Please click here for the meeting submission deadlines and meeting dates.

All ethics amendments and safety notifications are to be submitted through REGIS: REGIS recognises amendments and safety notifications as forms.

Amendment forms include: General Amendments Ethics Approval Extension Requests Addition of site – CV to be uploaded into REGIS Change in PI/CPI

The amendment form and supporting documentation must be submitted. These documents must be submitted in both clean and tracked copies with correct version numbers entered into REGIS.

Please note the file name of the document uploaded must match original file name.

Please ensure the completed NSLHD method of payment form for amendments is submitted into REGIS.

Safety Notification forms include: Reporting Local Safety events to the Institution Serious Breach Notification Significant Safety Issue (SSI)

Please follow the REGIS quick reference guides for step by step instruction on how to submit amendments and safety notifications for ethics. Hard Copy Ethics submissions will not be processed by the Research Office.

Please note the above process is for ethics amendments and safety reporting only. Please refer to the NSLHD Research Office website for guidance on governance amendment submissions.

Page 2:  · Web viewfor step by step instruction on how to submit amendments and safety notifications for ethics. Hard Copy Ethics submissions will not be processed by the Research Office