Andrea LeeResearch Ethics and Governance Coordinator

SWSLHDREGIS Training

Responding to further information requests

Research Directorate Research Ethics and

Governance Manager –Jessica Grundy (oversee all office functions including HREC, Research Governance and Research Contracts)

Research Ethics and Governance Coordinator –Andrea Lee (HREC and Research Governance)

Senior Administration Officers – Malina Peng (HREC and Research

Governance Administration)

– Logan Lown (HREC and Research Governance Administration)

Migration deadline 30 August 2019

Most existing active research projects that have been approved and authorised prior to 1 January 2019 have been migrated to REGIS.

This is a reminder to login to your REGIS account to check that all active studies you are involved in have been migrated and that the details are correct.

If a study has not been migrated please inform the Research Directorate no later than 30 August 2019 so that the office can investigate and include the application for migration by the NSW REGIS Team which is due to take place in September 2019.

Migration deadline 30 August 2019

When checking if your project has been migrated please note: Login using all your possible email addresses – this includes your university email address or your old SSWAHS email address. If the project was originally submitted via your SSWAHS email address, it will be on REGIS with the SSWAHS email address. You are able to migrate your project to your preferred email address by contacting the REGIS Helpdesk on 1300 073 447 and asking for the emails to be merged.

If you are not the Coordinating Principal Investigator of the project, you may not see the project on your list. Contact the Coordinating Principal Investigator first and ask them to share access with you. A Quick Reference Guide with instructions on how to do this can be found here: https://regis.health.nsw.gov.au/media/1420/qrg-resapp-sharing-access-v11.pdf

If you find that a project is still active and is not on your list in REGIS please contact the Research Directorate on SWSLHD-ethics@health.nsw.gov.au before 30 August 2019 and provide the local project number (HExx/xxx).

Research Ethics and Governance Information System (REGIS)

Google ‘REGIS’https://regis.health.nsw.gov.au/

REGIS – Quick Reference Guides (QRG)

REGIS – Quick Reference Guides (QRG)

Edit AccessCPI will be able to give application access to team members to draft the ethics and SSA responses. NOTE: The CPI and PI must submit the final forms in replacement of physical signatures.

ETHICS – Status Flowchart1. Submitted when you submit the HREA.

2. Eligible / Ineligible after administration checks are done.

3. If ineligible, follow QRG – Ineligible Notification – Resubmitting Application. The HREA will then go back to submitted.

4. Under Review/Assigned to meeting when the HREA is with the Ethics Committee for review.

5. If further clarification is needed, HREA will be Information Requested . Please note that we require a response cover letter and updated documents in tracked and clean.

6. To submit further information, follow QRG: Responding to a Request for Information – Initial Application. Status will become Information Provided. This means it is with our office.

7. If the application is ready for approval as deemed by the Ethics Committee, the HREA will be Approved. You will receive an approval email via REGIS.

SSA – Status Flow Chart1. Completed Pending HOD - awaiting support from the HOD in REGIS

2. Pending Submission – awaiting for the CPI to submit in REGIS

3. Submitted - submitted the SSA to the Research Directorate

4. Eligible / Ineligible after administration checks are done.

5. If ineligible, follow QRG – Ineligible Notification – Resubmitting Application. The HREA will then go back to submitted.

6. Information Requested – The Research Directorate has requested further information.

7. In Progress – Awaiting response from the CPI to the further information request sent

8. Information Provided – Further Information Request provided in REGIS – awaiting Research Directorate to review.

9. Pending CE approval – Awaiting for the CE/DOR to provide approval

10. Authorised – SSA authorisation email sent via REGIS

Responding to an ineligibility notification for Ethics + SSA:1. Log into REGIS

2. Locate the application with the status of

3. Click on the 3 dots next to the application

4. The application information menu will appear, please select “new version”

Responding to an ineligibility notification for Ethics + SSA:

5. A second message will appear. Unless you have been instructed, do not change the Application title. In the application comments cell, add a note to describe why you are submitting a new version, e.g. Resubmission after ineligible notification. Then click ‘New version’.

6. The status of the application will have changed from “ineligible” to “in progress” which means you can now edit the form.

7. Click on the application: e.g. 2019/ETH0000 or 2019/STE0000 – an editable version of the form will now open – make changes required.

Responding to an ineligibility notification for Ethics + SSA:

8. Update, add or remove documents: On the left hand side of the menu select upload:

Note: To update a document in the HREA DO NOT change the electronic filename of any updated documents. The HREA requires the electronic filename to remain the same even when a new version of the document is uploaded.

The filename should not include any version or dates. This detail can be added to the description of attachment for the HREA. If you have been asked to update the Protocol this is located at question 4.1 All other project wide/master documents are located at question 4.2.

9. Upon selecting “upload” select “clear content selection” then select “upload new”

10. Click on “choose file” then click on the “start upload” button.

Responding to an ineligibility notification for Ethics + SSA:Note: To update a document on the SSA please do not change the electronic filename of any updated documents including document type. However, please enter in the document description in the following format e.g. (PISCF-RNSH-Intervent) as it is 20 characters max. The document version and date should be as listed on the document.

11. To add a new document click on the “add” icon at the bottom left of the document table, a new document line should appear.

12. Add the description of the attachment and select “upload New”.

13. To remove a document please select the document to be removed with the tick box selection next to “document title” then click on the “delete” icon at the bottom left of the document table.

Responding to an ineligibility notification for Ethics + SSA:

14. Resubmit the application once all changes have been made by moving to the end of the form using the left hand menu: Click on the following options as appropriate:

Responding to an ineligibility notification for Ethics + SSA:

Once you have resubmitted the application, the Research Directorate will manage the application review and approval process. If your application is now eligible, it will progress to the appropriate review.

Responding to a request for information –Ethics + SSA

1. Log into REGIS

2. Locate the application with the status of “information requested” or “decision pending further information”

3. Click on the 3 dots next to the application

4. The application information menu will appear, please select “new version”

Responding to a request for information –Ethics + SSA

5. Update the application form by clicking the application e.g. 2019/ETH000 or 2019/STE000 - An editable version of the application will open to make any changes required.

Note: The status of the application will have changed to ‘in progress’ when the email notification was sent advising of the request for information.

Responding to a request for information –Ethics + SSA

6. Update add or remove documents: On the left-hand side menu of the form: HREA: Upload (ethics application) SSA: Part F Attachments – Sites Specific Documents (governance

application) SSA: HREA:

Responding to a request for information –Ethics + SSA Notes for consideration:

Response Letter/Cover letter: Create a response letter/cover letter that addresses all points raised in the request for further information and upload this for both SSA and Ethics responses.

Please ensure that documents that have updates/changes are uploaded in both tracked and clean versions.

Please ensure that version numbers and dates are updated in tracked and clean versions in the footer on each page of the document.

Responding to a request for information –Ethics + SSA 7. Submit the application once you have completed all the changes to the application form and the documents, finalise the response by moving to the end of the form and using the left-hand menu. Click on HREA: Generate HREA Document (for ethics application) – or Part G Declaration then Complete SSA (for SSA application).

SSA: HREA:

Responding to a request for information –Ethics + SSA

The status will then change to:

9. You have completed the request for information.

Who do I contact? Research DirectorateFor: for assistance with registration, applications, and post-approval/authorisation matters such as: information/documents you need to include, missing or incorrect dep’t information (site-governance applications), and how to use REGIS (non-technical).Location – Level 2 UNSW clinical School – Liverpool Hospital E-mail: SWSLHD-Ethics@health.nsw.gov.auWebsite: http://www.swslhd.nsw.gov.au/ethics/Phone: 02 8738 8304

REGISFor: technical queries such as system issues or faults, and account access issues. The Help desk is available 7am-7pm Monday-Friday, excluding ACT Public Holidays.Email: support@f1solutions.com.auWebsite: https://regis.health.nsw.gov.au/Phone: 1300 073 447

Questions