How-to Guides

Quick Reference Guides

Quick Reference Guides (QRGs) contain step-by-step instructions to help users work in REGIS.

Any queries please contact your local research office at these links: NSW or ACT.

For guidance on the latest policies and governance procedures, visit the OHMR website.

 

Applicants

The following QRGs will help applicants register a project, complete their applications and create and submit post-approval activities. Note some QRGs apply to more than one category.

 

Quick Reference Guides

Walk-Through Videos
REGISTRATION including NMA  

Project Registration
This document describes when Ethics is REGIS (NSW/ACT) and when Ethics is
outside of REGIS (QLD,VIC, SA,WA), replacing the NMA in REGIS document.

Completing and Submitting
Project Registration

Sharing Access to an Application/Project

 

Withdrawing an Application

 

ETHICS: APPLICATION (initial submission to approval)

 
HREA/Ethics Application - Completing and Submitting Completing and Submitting
HREA/Ethics Application

Ineligible Notification - Resubmitting Application

Video Coming Soon 

Responding to a Request for Information - Initial Application

Responding to a Request for
Information Initial Application

Downloading a Copy of your Ethics Application

 
ETHICS: POST-APPROVAL (amendments, safety reporting, progress reporting)  

Ethics Amendment - Completing and Submitting

Video Coming Soon 
Ethics Amendment - Responding to an Information Request Video Coming Soon 

Submitting Annual Progress or Final Report (Milestone)

Video Coming Soon 

Clinical Trial Safety Reporting

Video Coming Soon 

 

SITE GOVERNANCE

 

Site Application - Completing, Requesting Support and Submitting

Completing and Submitting
Site Application

Site Application - Head of Department (HOD) Not Supported

Video Coming Soon 

Create a New Site Application
Use this guide when project registration has already been submitted and:
* You need to create a new/additional site application before NSW/ACT ethics has
been approved OR
* When a non-NSW HREC has approved a new NSW site

Video Coming Soon 

Ineligible Notification - Resubmitting Application

Video Coming Soon 
Responding to a Request for Information - Initial Application Video Coming Soon 
GOVERNANCE: POST-APPROVAL (amendments, local safety reporting, milestones)  
Quick Reference Guides Walk-Through Videos

Governance Amendment - Completing and Submitting

Completing and Submitting
Governance Amendments

Governance Amendment - Responding to an Information Request

Video Coming Soon 

Submitting Governance Milestones

Submitting
Governance Milestones
 

Clinical Trial Safety Reporting

Video Coming Soon 

 

 

https://www.omnistar.cloud/ https://www.f1solutions.com.au/