Forms and Templates
Guidance relating to COVID-19 submissions:
Update 24.03.2020:
Link to: SWSLHD Guidance Document for the submission of research applications, amendments, Significant Safety Issue Notifications, Serious Breach Reports and Suspected Breach Reports relating to COVID-19
Given the evolving nature of the COVID-19 situation, the Research Directorate – Research Ethics and Governance Unit will only be holding meetings via telephone / Skype until further notice. If you have any research enquiries, please send an email to SWSLHD-Ethics@health.nsw.gov.au or call 8738 8304 or 8738 8314 and we will get back to you as soon as possible.
Please also note that if you need to send a research agreement to the office, please do so by external mail (Research Directorate –Research Ethics and Governance Unit, Administration Building, Eastern Campus, Liverpool Hospital Locked Bag 7279, Liverpool BC 1871) or internal mail (Research Directorate – Research Ethics and Governance Unit, Level 2, Liverpool Hospital). If coming from external mail, please ensure a prepaid envelope is included for return of counter-signed research agreements. If sending via internal mail, please ensure details are provided on a separate note in regard to the Internal Department to send the counter-signed agreement. Please note that the Research Directorate is not responsible for any mail lost in transit.
Given that some of our Ethics Committee members may be required to assist with surge planning and service delivery as the COVID-19 situation evolves, there may be delays with Ethics reviews and approval.
Please do not hesitate to contact the Research Directorate on 8738 8304 or 8738 8314 if you have any questions. We look forward to working with you and supporting you with your research. We hope you stay safe and healthy over the next few months.
For further guidance please refer to the below links:
NHRMC COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors:
www.nhmrc.gov.au/research-policy/COVID-19-impacts
The NSW Office for Health and Medical Research (OHMR) COVID-19: Guidance for sponsors, researchers, HRECs and RGOs
https://www.medicalresearch.nsw.gov.au/covid-19-clinical-trial-guidance/
NOTE: All applications have now been migrated to REGIS. Please use the REGIS forms from 1 April 2019. The only form to be used outside of REGIS is the Multicentre Cover Letter for amendments where SWSLHD HREC is not the lead HREC.
Further Information Response - Ethics/SSA
When you have received a request to provide further information to either an Ethics application or an SSA, please complete the SWSLHD Ethics/SSA Response Cover Letter.
Is your project low risk, greater than low risk or quality improvement?
If you need advice, we strongly encourage you to submit a Decision Aid so that we can provide a determination of the best application pathway for your project. Please email the Decision Aid to SWSLHD-Ethics@health.nsw.gov.au
Decision Aid
Study Documents
It is strongly recommended that if you are conducting an investigator initiated study, to use the Protocol Template.
Protocol Template
Please use the instructions in the below document to prepare your Master Documents and Site Specific Documents.
Preparing Site Specific Documents (SSD)
Clinical Trial Forms
FM_002_Contact Report version 1
FM_006_Protocol Specific Training Log version 1
FM_007_Delegation of Responsibilities Log version 1
FM_008_Individual Training Log version 1
FM_009_Essential Documents for Conduct of Clinical Trials Checklist version 1
FM_010_Overall ISF Management in Clinical Trials version 1
FM_011_ISF Contents Template version 1
FM_012_Essential Document Storage Location v1.0
FM_013_
FM_014_
FM_015_Protocol Amendment Storage Location v1.0
FM_016_
FM_017_
FM_018_Corrective and Preventative Action (CAPA) Plan
FM_019_Participant IP Accountability Log v1.0
FM_020_Batch IP Accountability Log v1.0
FM_021_IP Returns Log v1.0
FM_022_
FM_023_Site Initiation Visit Checklist v1.0
FM_024_
FM_025_Orientation Manual v1.0
FM_026_Biological Specimen Tracking Log v1.0
FM_027_
FM_028_Handover Form v1.0
FM_029_Core Competencies Form
Participant Information Sheet and Consent Form Templates
Interventional Participant Information Sheet Self
Interventional Consent Form Self
Interventional Participant Information Sheet Person Responsible
Interventional Consent Form Person Responsible
Interventional Participant Information Sheet Parent Guardian
Interventional Consent Form Parent Guardian
Genetic Participant Information Sheet Self
Genetic Participant Information Sheet Person Responsible
Genetic Participant Information Sheet Parent Guardian
Health & Social Science Participant Information Sheet Self
Health & Social Science Information Sheet Person Responsible
Health & Social Science Information Sheet Parent Guardian
Non-Interventional Participant Information Sheet Self
Non-Interventional Participant Information Sheet Person Responsible
Non-Interventional Participant Information Sheet Parent Guardian
Consent Form Self
Consent Form Parent Guardian/Person Responsible
Consent Form - Interventional
SWSLHD Ethics Amendment
This Amendment Form is to be used where SWSLHD is the lead Ethics for your project. It is a condition of Ethics Approval to notify Ethics if you make any changes to your approved documents. Please submit your documents in tracked and clean versions, with an updated version number and date on REGIS.
Please follow this Quick Reference Guide for how to complete an Amendment on REGIS - https://regis.health.nsw.gov.au/media/1355/qrg-resapp-ethics-amendment-completing-and-submitting-v11-final.pdf
SWSLHD Annual Report
Please note that REGIS has released an enhancement in the system for Annual Reports which is more user friendly and compliant with our requirements. Therefore as of 8 November 19, SWSLHD will NOT be accepting Annual Reports via email on the Annual Report template.
For projects where SWSLHD HREC is the lead HREC, please complete the annual report via REGIS following the 'Submitting a Progress/Final Report' Quick Reference Guide which can be found on their website.
For projects where SWSLHD HREC is NOT the lead HREC, please still submit using the MC Cover letter below and email the acknowledgement and annual report to our email address.
Safety Reporting for Clinical Trials
As of October 3, 2017, the NSW OHMR has formally accepted the updated NHMRC Safety Reporting Guidance. This will now align with national and international standards. This is effective now, and applies to new and existing trials. Fewer reports are required, and all safety reporting to the HREC and/or RGO is the responsibility of the sponsor of the trial. For more information click here.
Please log onto REGIS to submit a Significant Safety Issue, Serious Breach Notification of Safety Event form - https://regis.health.nsw.gov.au/
Amendment Form for Projects with a Different Lead Ethics (not SWSLHD) - including Addition of Investigators and Governance Amendments (including CTRA amendments)
Please use the below Multi-Centre Cover letter, attach all documents, HREC approvals and send to SWSLHD-ethics@health.nsw.gov.au for review by the office. Link to cover letter: Multi-Centre Cover Letter
Adding Investigators where SWSLHD is not the lead HREC
Please submit the following documents to SWSLHD-ethics@health.nsw.gov.au to add any investigators where SWSLHD is not the lead HREC.
Curriculum Vitae
Declaration of Researchers
Good Clinical Practice - clinical trials
Confidentiality - Non NSW health employee and both on-site and off-site
Criminal Record Check - Working on-site and non NSW health employee
Adding Investigators to an Approved Study by SWSLHD
Please submit this as a General Amendment to your study in REGIS - https://regis.health.nsw.gov.au/
Please follow this Quick Reference Guide for how to complete an Amendment on REGIS - https://regis.health.nsw.gov.au/media/1355/qrg-resapp-ethics-amendment-completing-and-submitting-v11-final.pdf
To add investigators to the study we require the following:
IF the study is a clinical trial - Good Clinical Practice Certificate
IF the investigator is not a NSW Health employee - Confidentiality Form
IF working on-site and not a NSW Health employee - A Criminal Record Check done within the last 12 months. Working onsite involves contacting patients and/or viewing SWSLHD patient data.
TRANSLATED DOCUMENTS
Please note that the translated documents are required to be translated by a NAATI accredited translator and submitted to the research directorate for review/approval prior to use for all projects. Link: https://www.naati.com.au/
NSW Health Statewide Biobank Consent Toolkit
The NSW Office for Health and Medical Research (OHMR) in collaboration with the NSW Health Statewide Biobank (NSWHSB) released the NSW Health Statewide Biobank Consent Toolkit in February 2018.
The Consent Toolkit provides guidance to biobanking stakeholders on consenting including use of broad-based consent, the return of incidental findings, and data linkage to NSW Health datasets. Adoption of this robust consent process will better support ethical human research and provide a sustainable approach to managing human biobanks across the State.
Compliance with the Consent Toolkit is mandatory for prospective collections of the Statewide Biobank. It is encouraged that all NSW research biobanks seeking consent from potential biobanking participants comply with the Consent Toolkit.
The Consent Toolkit contains:
1. Consent Principles and Protocol
2. Participant Information Sheet
3. Consent Form
4. Ethically Defensible Plan
5. Compliance Checklist
CALD Resources
CALD (Culturally and Linguistically Diverse) Research is a focus for SWSLHD. Please see this link for useful resources if you are considering incorporating some CALD elements into your research and/or would like access to resources to potentially include CALD groups in your study. The resources included in the link are reviewed by NSW Health for accuracy.
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