How-to Guides

Quick Reference Guides

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

Please contact your local research office regarding what information to include in your application using these links: NSW or ACT.

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

All users

Quick Reference Guides

Walk-Through Videos

Updated videos to be uploaded
in near future

Creating and Managing a REGIS User Account and System Symbols

 

Status Definitions

 

Update your REGIS Username and Password

 

 

Applicants

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

 

Quick Reference Guides

Walk-Through Videos

Updated videos to be uploaded
in near future

Project Registration

Describes when Ethics exists in REGIS and outside of REGIS

Completing Project Registration 

Sharing Access to an Application/Project

Sharing Access to an Application or Project 

Withdrawing an Application

Withdrawing, Deleting In Progress Version and Deleting an Application

ETHICS: APPLICATION (Initial submission - pre-approval)

 

HREA/Ethics Application - Completing and Submitting

Completing an Ethics Application 

Ineligible Notification - Resubmitting Application

Resubmitting an Ineligible Application 

Responding to a Request for Information - Initial Application

 Responding to a Request for Information

Downloading a copy of your Ethics Application

Downloading a copy of your Application
ETHICS: POST-APPROVAL (amendments, safety reporting, progress reporting)  

Ethics Amendment - Completing and Submitting

Creating and Submitting an Ethics Amendment 
Ethics Amendment - Responding to an Information Request  Responding to a Request for Information - Amendments and Safety Notifications

Submitting Annual Progress or Final Report (Milestone)

Creating and Submitting an Ethics Progress Report and Responding to a Request for Information 

Clinical Trial Safety Reporting

Creating and Submitting an Ethics Safety Notification

 

SITE GOVERNANCE (Initial submission - pre-authorisation)

 

Site Application - Completing, Requesting Support and Submitting

Completing a Site Application 

Site Application - Head of Department (HOD) Not Supported

Resubmitting when HOD Not Supported 

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

Creating a New Site Application 

Ineligible Notification - Resubmitting Application

Resubmitting an Ineligible Application 
Responding to a Request for Information - Initial Application  Responding to a Request for Information
Downloading a copy of your Site Application Downloading a copy of your Application
GOVERNANCE: POST-APPROVAL (amendments, local safety reporting, milestones)  
Quick Reference Guides

Walk-Through Videos

Updated videos to be uploaded
in near future

Governance Amendment - Completing and Submitting

Creating and Submitting a Site Amendment 

Governance Amendment - Responding to an Information Request

 

Submitting Governance Milestones

 

Clinical Trial Safety Reporting

Creating and Submitting Site Safety Notifications 

 

Research offices

The following guides will help research offices set up their home page, review applications, create and manage meetings, and review post-approval/authorisation activities.

 

Quick Reference Guides

Walk-Through Videos

Updated videos to be uploaded
in near future

SETUP AND HOME PAGE

 

Starting in REGIS

 

Setting Up a Home Page

Home Page Tiles Described

 

ETHICS

 

Reviewing Eligibility of an Ethics Application

Completing Eligibility Review 

Requesting More Information (Initial Application)

Requesting Further Information 

Processing Approval & Authorisation - Not Associated with Meetings (Initial Application)

 

Processing Ethics Amendment

 

Processing an Annual Progress Report/Final Report (Milestone)

 

MEETINGS AND REVIEWS including HREC

 

Creating and Managing Reviews

 

Creating and Preparing HREC Meetings

 

Managing HREC Meetings and Decisions

 

SITE

 

Reviewing Eligibility of a Site Application

Completing Eligibility Review 

Review Site Application & Request Information

Requesting Further Information 

Processing Approval & Authorisation - Not Associated with Meetings (initial application)

 

Processing Site Amendment

 

Processing Governance Milestones (Annual Progress Reports and Certificate of Currency)

 

Process Governance Site Safety to be uploaded (see Process site amendment)

 

DASHBOARDS & REPORTS

 

Dashboard - Ethics and Site

 

Dashboard - Live Clock

 

Dashboard - NHMRC

 

Application Overview Page

 

OTHER

 

New Head of Department Upload - Template Spreadsheet

 

User Management

 

Correcting Outgoing Correspondence

 

 

Additional QRGs for all REGIS Users

The following guides will help non-research office staff manage applications through the review and approval processes.

Quick Reference Guides

Walk-Through Videos

Updated videos to be uploaded
in near future

Chief Executive/Delegate - Authorising Governance Applications 

 

Heads of Department - Providing Declarations of Support

Providing HOD Support 

HREC Member - Accessing Meeting Documents

 

HREC Member - Completing the Lead Review

 
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