How-to Guides

Quick Reference Guides

Quick Reference Guides (QRGs) contain step-by-step instructions to help users work in REGIS. There are QRGs for all users, and separate QRGs for research applicants, research offices and non-research office staff.

QRGs will be continually updated and new ones will be added.

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.

All users

Quick Reference Guides	Walk-Through Videos
Creating and Managing a REGIS User Account and System Symbols v1 30 September 2020
REGIS Status Definitions and Glossary v1 30 September 2020
Update your REGIS Username and Password v2 16 March 2020

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
COVID-19 DATA COLLECTION
Researcher Guidance on COVID-19 Data Entry v1 6 April 2020
REGISTRATION including NMA
Project Registration v6.1 30 September 2020 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 v2 16 March 2020
Withdrawing an Application v2.1 30 September 2020
ETHICS: APPLICATION (initial submission to approval)
HREA/Ethics Application - Completing and Submitting v4.1 30 September 2020	Completing and Submitting HREA/Ethics Application
Ineligible Notification - Resubmitting Application v2.1 30 September 2020
Responding to a Request for Information - Initial Application v2.1 30 September 2020	Responding to a Request for Information Initial Application
Downloading a Copy of your Ethics Application v2 30 September 2020
ETHICS: POST-APPROVAL (amendments, safety reporting, progress reporting)
Ethics Amendment - Completing and Submitting v3.3 30 September 2020
Ethics Amendment - Responding to an Information Request v2.1 30 September 2020
Submitting Annual Progress or Final Report (Milestone) v3 30 September 2020
Clinical Trial Safety Reporting v3 30 September 2020
SITE GOVERNANCE
Site Application - Completing, Requesting Support and Submitting v2.1 30 September 2020	Completing and Submitting Site Application
Site Application - Head of Department (HOD) Not Supported v2.1 30 September 2020
Create a New Site Application v2.1 30 September 2020 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
Ineligible Notification - Resubmitting Application v2.1 13 August 2020
Responding to a Request for Information - Initial Application v2.1 30 September 2020
GOVERNANCE: POST-APPROVAL (amendments, local safety reporting, milestones)
Quick Reference Guides	Walk-Through Videos
Governance Amendment - Completing and Submitting v1.1 30 September 2020	Completing and Submitting Governance Amendments
Governance Amendment - Responding to an Information Request v1 30 September 2020
Submitting Governance Milestones v1.1 30 September 2020	Submitting Governance Milestones
Clinical Trial Safety Reporting v3 30 September 2020

Research offices

The following QRGs will help research offices set up their home page and meetings, and review eligibility.

Quick Reference Guides	Walk-Through Videos
SETUP AND HOME PAGE
Starting in REGIS v2.1 30 September 2020
Setting Up a Home Page v3.1 30 September 2020 Home Page Tiles Described v5.2 30 September 2020
ETHICS
Reviewing Eligibility of an Ethics Application v2.1 30 September 2020
Requesting More Information (Initial Application) v2.1 30 September 2020
Processing Approval & Authorisation - Not Associated with Meetings (Initial Application) v3 30 September 2020
Processing Ethics Amendment v4 30 September 2020
Processing an Annual Progress Report/Final Report (Milestone) v4 30 September 2020	Processing an Annual/Final Progress Report Milestone
MEETINGS AND REVIEWS including HREC
Creating and Managing Reviews v4.1 30 September 2020
Creating and Preparing HREC Meetings v3.1 30 September 2020
Managing HREC Meetings and Decisions v3.1 30 September 2020
SITE
Reviewing Eligibility of a Site Application v2.1 30 September 2020
Review Site Application & Request Information v5 30 September 2020
Processing Approval & Authorisation - Not Associated with Meetings (initial application) v3 30 September 2020
Processing Site Amendment v1 30 September 2020	Processing Site Amendments
Processing Governance Milestones (Annual Progress Reports and Certificate of Currency) v1 30 September 2020	Processing Governance Milestones
Process Governance Site Safety to be uploaded (see Process site amendment)	Processing Governance Site Safety Forms
OTHER
New Head of Department Upload - Template Spreadsheet v1 16 March 2020
COVID-19 Data Entry: Research Office Guidance v1 6 April 2020
Correcting Outgoing Correspondence v2.1 30 September 2020

Additional QRGs for all REGIS Users

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

Quick Reference Guides	Walk-Through Videos
Chief Executive/Delegate - Authorising Governance Applications v2.1 30 September 2020
Heads of Department - Providing Declarations of Support v4.2 30 September 2020	Head of Department Providing Declaration of Support via Email	Head of Department Providing Declaration of Support via REGIS
HREC Member - Accessing Meeting Documents v2.1 30 September 2020
HREC Member - Completing the Lead Review v2.1 30 September 2020	Completing a Review

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