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

Glossary	v1.1	16 March 2020
Creating and managing your REGIS Account	v2	16 March 2020
Update your REGIS username and password	v2	16 March 2020
Symbols	v2	16 March 2020
REGIS Status Definitions	v3	16 March 2020

Applicants

The following QRGs will help applicants register a project and complete their applications. Note some QRGs apply to more than one category.

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.	v5	16 March 2020
Sharing access to an application/project	v2	16 March 2020
Withdrawing an Application	v2	16 March 2020

ETHICS: APPLICATION (initial submission to approval)
HREA/Ethics Application - Completing and Submitting the Application	v4	16 March 2020
Ineligible Notification - Resubmitting Application	v2	16 March 2020
Responding to a Request for Information - Initial Application	v2	16 March 2020
Downloading a copy of your ethics application	v2	16 March 2020
ETHICS: POST-APPROVAL (amendments, safety reporting, progress reporting)
Ethics Amendment - Completing and Submitting	v2	16 March 2020
Ethics Amendment - Responding to an Information Request	v2	16 March 2020
Submitting Annual Progress or Final Report (Milestone)	v2	16 March 2020
Clinical Trial Safety Reporting	v2	16 March 2020
SITE GOVERNANCE
Site Application - Completing, Requesting Support and Submitting	v2	16 March 2020
Site Application - Head of Department (HOD) Not Supported	v2	16 March 2020
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	v2	16 March 2020
Ineligible Notification - Resubmitting Application	v2	16 March 2020
Responding to a Request for Information - Initial Application	v2	16 March 2020

Research offices

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

SETUP AND HOME PAGE
Starting in REGIS	v2	16 March 2020
Setting up a Home Page	v3	17 Apr 2019
ETHICS
Reviewing Eligibility of an Ethics Application	v2	16 March 2020
Requesting more Information (initial application)	v2	16 March 2020
Processing Approval & Authorisation - not Associated with Meetings (initial application)	v2	16 March 2020
Processing Ethics Amendment	v2	16 March 2020
Processing an Annual Progress Report/Final Report (Milestone)	v2	16 March 2020
MEETINGS AND REVIEWS including HREC
Creating and Managing Reviews	v3	16 March 2020
Creating and Preparing HREC Meetings	v2	16 March 2020
Managing HREC Meetings and Decisions	v2	16 March 2020
SITE
Reviewing Eligibility of a Site Application	v2	16 March 2020
Review Site Application & Request Information	v4	16 March 2020
Processing Approval & Authorisation - not Associated with Meetings (initial application)	v2	16 March 2020
OTHER
Correcting Outgoing Correspondence	v2	16 March 2020
Data Migration - Manual STE Creation * webinar available here	v1	17 March 2020

Additional QRGs for all REGIS Users

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

Chief Executive/Delegate - Authorising Governance Applications	v2	16 March 2020
Heads of Department - Providing Declarations of Support	v3	16 March 2020
HREC Member - Accessing Meeting Documents	v2	16 March 2020
HREC Member - Completing the Lead Review	v2	16 March 2020

User Manual

1.	Research Office
1.1	Homepage tile	v4	17 April 2019
1.2	Application search	v1	23 July 2018

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