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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