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Clinical Trials
Submission Guidelines
Including Clinical Research Groups and
Investigator Driven Trials
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 2
CONTENTS
INTRODUCTION ............................................................................................................. 4
NATIONAL STANDARD OPERATING PROCEDURES FOR CLINICAL TRIALS, INCLUDING
TELETRIALS IN AUSTRALIA............................................................................................... 5
SITE SPECIFIC ASSESSMENT SSA .................................................................................. 5
TECHNICAL SUPPORT ................................................................................................................ 5
HELPFUL HINTS ......................................................................................................................... 6
DUAL SUBMISSION.................................................................................................................... 6
CLINICAL TRIAL NOTIFICATION CTN ........................................................................... 7
CLINICAL TRIALS RESEARCH AGREEMENT (CTRA) ...................................................... 8
SCHEDULE 2: ........................................................................................................................ 8
Governance Fee ........................................................................................................................ 8
Pharmacy Fee ........................................................................................................................... 9
PAYEE ...................................................................................................................................... 9
INDEMNITY..................................................................................................................... 9
INSURANCE ................................................................................................................. 10
SA HEALTH EMPLOYEES ........................................................................................................... 10
DUAL EMPLOYMENT ............................................................................................................... 10
NON-SA HEALTH EMPLOYEES ................................................................................................... 10
THIRD PARTY SPONSORS ......................................................................................................... 10
NALHN Credentialling ............................................................................................................. 10
ESSENTIAL DOCUMENTS .............................................................................................. 11
SSA FEE FORM ........................................................................................................................ 11
STUDY PROTOCOL ................................................................................................................... 11
PARTICIPANTS INFOMRATION SHEETS CONSENT FORM (PISCF) .................................................. 11
INVESTIGATORS CVs ................................................................................................................ 11
GOOD CLINICAL PRACTICE CERTIFICATE .................................................................................... 12
POLICE CLEARANCES ............................................................................................................... 12
CONFIDENTIALDY AGREEMENTS FOR NON- SA HEALTH STAFF .................................................... 12
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 3
TRIAL COORDINATOR FORM .................................................................................................... 12
RADIATION SAFETY REPORT / STANDARD OF CARE DECLARATION BY PI ...................................... 13
ADVERTISING ......................................................................................................................... 13
OTHER LEGAL CONTRACTS AND AGREEMENTS ........................................................... 14
NEXT STEPS................................................................................................................... 15
SIGNING ................................................................................................................................. 15
LODGING YOUR APPLICATION .................................................................................................. 15
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 4
INTRODUCTION
In accordance with the SA Health Research Governance Directive, all research within the Northern Adelaide
Local Health Network (NALHN) requires authorisation of the delegated officer (Executive Director of Medical
Services) before commencing. The Research Governance Office is keen to discuss your project proposals with
you at an early stage wherever possible and is here to help navigate the necessary paperwork needed to lodge
a research application.
At a minimum, this will include a Site-Specific Assessment (Submitted via GEMS), research protocol, Ethics
approvals, and other supporting documents, depending on the type of study.
This guide relates to Clinical Trials, including CRG and Investigator driven trials. These are trials where NALHN
is not the Sponsor. In cases where NALHN is the trial sponsor, please refer to the Investigator Initiated
Submission Guideline.
.
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 5
NATIONAL STANDARD OPERATING PROCEDURES FOR CLINICAL TRIALS, INCLUDING
TELETRIALS IN AUSTRALIA
Based on the International Council for Harmonisation Guideline for Good clinical practice ICH E6 (R2)
These National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia have been
developed to assist organisations engaged in conducting clinical trials in Australia to, wherever possible, standardise
their procedures for key operations related to clinical trials and specifically teletrials. They have been developed for
the National Mutual Acceptance (NMA) Scheme in Australia and to support a consistent approach to national
implementation more broadly. They have been endorsed by all states and territories, together with the Therapeutic
Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC), through the Clinical
Trials Project Reference Group (CTPRG).
The National Standard Operating Procedures for Clinical Trials, including Teletrials, form part of a Teletrials
Compendium, developed to support a consistent national approach to implementation of teletrials in Australia,
which includes:
the National Principles for Teletrials in Australia, and
the National Standard Operating Procedures for Clinical Trials, including Teletrials.
The documents within the Teletrials Compendium are consistent with minimum standard imposed by the
International Council for Harmonisation (ICH) Guideline for Good Clinical Practice E6 (R2) - an international ethical
and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and
reporting of clinical trials that involve participation of humans - and comply with the Integrated Addendum to this
Guideline published by the TGA.
SITE SPECIFIC ASSESSMENT SSA
Research that involves a risk of harm is considered more than low risk research. See link to the National Statement
on Ethical Conduct in Human Research (2007 Updated 2018)
Site Specific Assessment Form Greater than low risk studies are now required to be completed on the Research
Governance and Ethics Management System (GEMS) website which can be located at, Research GEMS . Please
review the user guides for step-by-step instructions on how to navigate the Research GEMS.
GEMS is designed to enable a more consistent and streamlined process for research applicants who wish to conduct
research within SA Health.
Research GEMS allows researchers to:
complete their Human Research Ethics Application and Site-Specific Assessment forms
monitor approval progress and
submit post approval monitoring to their local Research Office.
All SA Health sites are now accepting new applications for ethics and site assessments through Research GEMS. All
Current studies have been migrated into the system and can be accessed through the Research GEMS web-based
platform.
Feel Free to contact the NALHN Research Secretariat for further guidance or support healthnalhnrgo@sa.gov.au
TECHNICAL SUPPORT
Please review the user guides for step-by-step instructions on how to navigate the Research GEMS system or contact
the NALHN Research Secretariat on phone: 818-29346 or email: healthnalhnrgo@sa.gov.au for further guidance or
support.
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 6
HELPFUL HINTS
Frequently Asked Questions regarding GEMS
Completing the site application part C: Department and Services guide
DUAL SUBMISSION
Site assessment and ethical review may occur in parallel. However, the decision to authorise or not authorise
the commencement of a research project at the site can only be made once the HREC has approved the
project.
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 7
CLINICAL TRIAL NOTIFICATION CTN
As detailed on the Therapeutic Goods Administration of Australia (TGA) clinical trials website, the following
avenues provide for the importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in
a clinical trial.
Clinical trials that do not involve 'unapproved' therapeutic goods are not subject to requirements of the CTN or
CTX schemes. It is the responsibility of the Australian clinical trial sponsor to determine whether a product is
considered an 'unapproved' therapeutic good
CTN s are submitted via their online submission portal. Where NALHN is not the CTN sponsor of the clinical trial,
it is the responsibility of the study sponsor to submit the application and pay the submission fee.
In some circumstances such as investigator initiated clinical trials, please refer to the Investigator Initiated
guideline
In the event NALHN agrees to act as CTN sponsor, any relevant agreements (if any) must be in writing first to
clarify the obligations NALHN undertakes in its role as sponsor for a particular study and to determine how the
TGA submission fee will be paid by the group or reimbursed to NALHN (as the case may be).
NALHN also require researchers to provide all relevant information to be entered into the online CTN form and
to provide the RGO with a copy of the TGA notification letter as soon as practicab le. The RGO will liaise with you
regarding management of the CTN process for your study. TGA also charge a fee for lodging a CTN which must
be paid for by the local research unit out of the Special Purpose Fund (SPF). The NALHN Research Secretariat
office for Research cannot pay the CTN fee.
For sponsor initiated clinical trials, please attach a copy of the eCTN to your SSA.
The online CTN files Approving Authority Details for NALHN are as follows:
For investigator initiated clinical trials, the CTN must be submitted to the Therapeutic Goods Administration by
the Research Governance Office (please refer to fees schedule for current fees).
Information on the Clinical Trial Notification/Clinical Trial Exemption schemes is available at
https://www.tga.gov.au/clinical-trials
For sponsors submitting eCTNs for clinical trials being conducted at Lyell McEwin or Modbury Hospital the
approving authority information is provided below:
Name of Approving Authority: Northern Adelaide Local Health Network Incorporated operating as Lyell
McEwin Hospital (select appropriate site), or
Northern Adelaide Local Health Network Incorporated operating as Modbury Hospital
Approving Authority Contact Officer: Lorraine Cichon
Position: Research Governance Officer
Contact Phone: +61 8 8182 9346
health.nalhnrgoa.gov.au
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 8
CLINICAL TRIALS RESEARCH AGREEMENT (CTRA)
Each clinical trial to be conducted at NALHN and sponsored by a third party must be governed by a written
agreement clarifying the obligations and responsibilities of the parties involved in the trial. NALHN will only
accept CTRAs that use the standard agreement templates developed by Medicines Australia. Please ensure
that each document has been downloaded from the Medicines Australia website found here. The CTRA should
be submitted along with the SSA and must be reviewed by the NALHN Research Secretariat Office prior to
execution being undertaken.
If your project involves a medicine or device, you need to submit an agreement between the parties involved.
This is required whether you are involved in a:
? Collaborative Group project
? Commercially Sponsored project
? Contract Research Organisation or,
? Project funded from a grant
Medicines Australia Standard CTRA templates are endorsed by SA Health and should be used wherever possible
to avoid the need for legal review.
The Principal Investigator should be named in the Schedule 1. The Principal Investigator may sign the
agreement, but this is not required
The Schedule 2 must contain the provision for the payment of Ethics and Governances fees in line with SA
Health Research Ethics and Governance Review Fees Schedule, with the full budget being supported by the
divisions Business Consultant where the study is being undertaken.
Any amendment to the standard agreement must be made using the Special Conditions Schedule via SEBS
Committee using SEBS Review Template found via this link please ensure to scroll to the bottom of the page
to find the SEBS template Schedule 7 or Schdule 4 varaiation to the CTRA Template.
Site details for inclusion in the template (select appropriate site):
Name of Institution: Northern Adelaide Local Health Network Incorporated, operating as Lyell
McEwin Hospital
Address: Haydown Road, Elizabeth Vale, South Australia 5112
ABN: 46 371 200 573
Name of Institution: Northern Adelaide Local Health Network Incorporated, operating as Modbury
Hospital
Address: 41-69 Smart Road, Modbury, South Australia 5092
ABN: 46 371 200 573
SCHEDULE 2:
Governance Fee
Research governance submission fees are payable to the Institution according to the current fee schedule. The
research governance office will invoice the sponsor directly.
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 9
Pharmacy Fee
Be aware that SA Health may require a separate pharmacy agreement. Please contact
Health.LMHClinicalTrialsPharmacy@sa.gov.au
PAYEE
All payments listed in this schedule will be made by the Sponsor to Institution upon receipt of a tax invoice by
direct credit.
The NALHN banking details are: -
Bank: Commonwealth Bank of Australia
Branch: 96 King William St, Adelaide
BSB: 065 266 Account Number: 10020646
Account Name: NALHN Oracle Operating
ABN: 46 371 200 573
Swift Code: CTBAAU2S
Note: The sponsor is responsible for study payments and must be the party in Schedule 2 that NALHN will
invoice.
For information on how to negotiate the study budget for inclusion in the CTRA please review th e Budget
negotiation NALHN research projects
INDEMNITY
Medicines Australia Standard Indemnity templates are endorsed by SA Health.
Site details for inclusion in the template (select appropriate site):
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
( the Indemnified Party )
or
Northern Adelaide Local Health Network Incorporated, operating as Modbury Hospital
( the Indemnified Party )
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 10
INSURANCE
The Principal Investigator (PI) is responsible for confirming the insurance and indemnity arrangement for the
research project. The PI must provide all required supporting documentation to the RGO. This generally includes
copies of the relevant insurance certificates PLUS an email from the partnering organisation confirming that this
study is covered by the insurance.
Any changes to insurance (including annual renewal) must be lodged with the RGO for ratification.
Please be aware that some projects will require Legal Governance and Insurance Services (LGIS) to review and
approve insurance, and this can delay the processing of your SSA.
SA HEALTH EMPLOYEES
SA Health employees conducting a research project in the capacity of their employment with SA Health are
covered by SA Health insurance where approval from a SA Health HREC or National Mutual Acceptance (NMA)
HREC has been obtained. No further supporting documentation is required.
DUAL EMPLOYMENT
If the researcher is an SA Health Employee, but has dual employment with a University or South Australian
Health and Medical Research Institute (SAHMRI) or another organisation, or is also a university student, and is
conducting a research trial/project in the capacity of their non SA Health employment, or as pa rt of their
private studies, indemnity must be provided by the University or SAHMRI and/or third party sponsor.
NON-SA HEALTH EMPLOYEES
Conducting research at an SA Health organisation that involve SA Health patients, staff, resources or data to
support the project, the PI must provide appropriate insurance documentation from the non-SA Health
organisation. Appropriate insurance documentation includes current insurance certificate/s and written
insurance approval from the organisation. These requirements include research projects conducted by staff
and students of academic institutions, such as Universities
THIRD PARTY SPONSORS
For clinical research TRIALS with third party sponsors it is a requirement that the Sponsor indemnifies the trial
and provides evidence of indemnity, by way of Certificate of Currency (this is in addition to SA Health and/or
non-SA Health insurance cover).
For research PROJECTS sponsored by a third party, including commercially sponsored clinical trials, the sponsor
must supply evidence of its insurance cover. A sponsor s insurance cover must as a minimum identify the local
site, investigator and research staff, and participants involved in the research project. For all commercially
sponsored clinical trials, the Medicines Australia Form of Indemnity for Clinical Trials Standard must also be
submitted.
NALHN Credentialling
NALHN must ensure all staff, contractors, visiting private practit ioners, volunteers and students are
credentialed. If any of the investigators listed on the application are working at NALHN in clinical capacity, they
must have up-to-date credentialing within NALHN. If the credentialing details are out of date, we will request
evidence of renewal and the study will not proceed.
NALHN Credentialling Officer- Telephone 08 82821699 or email
Megan Glowik health.nalhncredentialling@sa.gov.au
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 11
ESSENTIAL DOCUMENTS
SSA FEE FORM
The NALHN Office for Research charges fees according to the SA Health Research Ethics and Governance Fees
Schedule available here. Please see the SA Health Fee Form SA Health Research Governance Fee Schedule
Within the SA Health fees schedule there are three categories that are covered:
1. Clinical Trials with Full Commercial Sponsorship
2. Non-Commercially Sponsored Clinical Trials / Cooperative Research Group (CRG)
3. Contract Review To define clinical trials we acknowledge the following the World Health Organisation
definition:
A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or
more health-related interventions to evaluate the effects on health outcomes
HUMAN RESEARCH ETHICS COMMITTEE (HREC)
NALHN does not have a Human Research Ethics Committee; however, the Research Governance Office will accept
any National Mutual Accepted HREC ethics with a Site-Specific Assessment form. NMA Ethics committees can be
located on the SA Health website.
STUDY PROTOCOL
The Study Protocol is an essential document for both the HREC and the RGO.
INVESTIGATOR BROCHURE
Where the trial involves drugs and/or devices, the Trial Sponsor will provide the Investigator Brochure. Where
devices are approved for use in Australia or internationally, an Instruction for Use (IFU) document could be
submitted as a replacement for the investigator brochure.
The title, version and date listed on the Investigator Brochure should be listed in the research protocol and
must match those listed on the HREC approval letter (including all future variations).
Please ensure that the filename is IB_Version_Date
PARTICIPANTS INFOMRATION SHEETS CONSENT FORM (PISCF)
NALHN endorses use of the NHMRC standardised PICFs which are designed for three categories of participants
identified by the National Statement:
When completing the Master PISCF and Site Specific PISCF please refer to the Participant Information Sheets
and Consent Forms fact sheet.
INVESTIGATORS CVs
All study Investigators should provide a current copy of their Professional/Academic CV. Please ensure that the
CV details relevant research experience, academic qualifications and publications
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 12
GOOD CLINICAL PRACTICE CERTIFICATE
As part of the implementation of the National Clinical Trials Governance Framework and the Therapeutic Goods
Administration (TGA) GCP Inspection Audits, investigators will be required to undertake GCP training and
subsequent refresher training to meet compliance as mandated by SA Health.
The various Health Networks are working with SA Health towards ensuring that all staff involved in any clinical
research (not only those involved in the design and conduct of clinical trials) undertake GCP training and hold a
current certificate in GCP. This includes principal investigators, associate investigators, trial
managers/coordinators and research nurses etc.
To ensure NALHN is compliant with the minimum training requirements, all staff (NALHN, SAHMRI, University
etc) involved with undertaking any clinical research at NALHN must undertake GCP training. Evidence of GCP
training will be part of the research ethics and research governance approval processes.
Certificates are kept on file in the Research Governance Office, so if you have provided a certificate within the
past two years, you do not need to provide it with every new SSA application.
Further information can be found on the Therapeutic Goods Administration website.
Global Health Network Training Centre
Syneos Health (formerly INC Research)
Please note: This is interim advice and further information will be provided when available from SA Health
POLICE CLEARANCES
Non-SA Health staff coming on site as part of a research study must provide a NALHN confidentiality deed and
National Police Certificate (NPC) if they are working with adults at NALHN. If the study involves participants
under the age of 18, child-related employment screening through the Department of Human Services (DHS) must
be provided in place of an NPC. This is to be in compliant with the South Australian Health Criminal and Relevant
History Screening Policy Directive available Criminal and Relevant History Screening. There are numerous options
for a police check online via accredited agencies. As a way to ensure compliance, screening and confidentiality
are standard conditions on our governance authorisation:
It is the responsibility of the Principal Investigator to ensure any non-SA Health personnel who conducts or
monitors research meets SA Health screening requirements as per the SA Health Criminal & Relevant Hist ory
Screening Policy Directive before they access any SA Health site. The cost of any such screening is the
responsibility of the individual accessing the site or their employer. Working with children check
CONFIDENTIALDY AGREEMENTS FOR NON- SA HEALTH STAFF
A Confidentiality deed for non- NALHN employee will need to be signed by all non-SA Health staff that will require
access to SA Health data.
TRIAL COORDINATOR FORM
NALHN rgo Research Coordinator Authorisation Form | SA Health
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 13
RADIATION SAFETY REPORT / STANDARD OF CARE DECLARATION BY PI
Standard of Care Radiation Letter Template
Research involving gene technology and related therapies, drugs and/or ionising radiation may require specific
notification, registration or licence requirements. Please refer to the SA Health Research Ethics Operational
Policy Directive.
All research involving any form of radiation must comply with relevant Nat ional and State legislation,
organisational policies and procedures, and codes and standards of practice provided by the NHMRC and the
Australian Radiation Protection and Nuclear Safety Agency (ARPANSA).
Evidence of these requirements (including the HREC approval) should be attached to the SSA to permit the RGO
to assess whether the appropriate processes and documents have been completed by the applicant.
ADVERTISING
All advertisements including the SA Health Logo, and all radio/television/press/social me dia advertising must be
first approved by the NALHN Communications Department:
HEALTH.NorthernCommunication@sa.gov.au
Evidence of approval from Media and Communications must be included with your SSA/LNR.
Corporate Identity Policy
https://www.sahealth.sa.gov.au/wps/wcm/connect/ddbe6580462bc31e8967896dc301fde5/Directive_Corporat
e%2BIdentity_Nov2014.pdf?MOD=AJPERES&CACHE=NONE&CONTENTCACHE=NONE
Social Media Policy
https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/contact+us/social+med
ia+policy+terms+and+conditions+of+use
SA Health Logos
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 14
OTHER LEGAL CONTRACTS AND AGREEMENTS
The NALHN Executive Director of Medical Services / or nominated delegate is the only person authorised to
sign contracts on behalf of NALHN. Do not edit the body of the standard agreement. Any non -standard
agreements (not on an approved template) will need to be reviewed by a legal representative prior to signing.
It is essential that any third-party agreements be negotiated and presented for signing at the same time as the
researcher lodges the SSA.
These commonly include:
Collaboration agreements with Universities/Medical Research Institutes/Hospitals
Funding agreements
Material Transfer Agreements (MTAs)
Multi-Institution Agreements (MIAs)
Intellectual Property Deeds
Moral Rights declarations
Service agreements
Import/Export permits
Student scholarship agreements
Sanctioned Country clearances
Researchers should be aware that contract negotiations may take months, so these should be discussed with
the Research Secretariat at the earliest opportunity.
NORTHERN ADELAIDE LOCAL HEALTH NETWORK
Clinical Trials Submission Guidelines 15
NEXT STEPS
SIGNING
Frequently Asked Questions regarding GEMS
Completing the site application part C: Department and Services guide
LODGING YOUR APPLICATION
For all Greater than Low Risk (SSA) Follow the GEMS system process as listed above.
Hard copies are not required (except for CTRA and Medicines Australia Indemnity forms)
Note that if your submission is being managed via GEMs you will need to ensure that the CTRA and Medicines
Australia Indemnity forms are provided to the Research secretariat via email healthnalhnrgo@sa.gov.au
NOTE CONTRACTS are not managed via GEMS. You need to email these to us. healthnalhnrgo@sa.gov.au
Once submitted, your application is reviewed by the RGO for final authorisation by the CEO/delegate. The project
must not commence until you receive a letter of authorisation from the RGO.
NALHN supports dual submission of ethics and governance. While SSAs can be submitted at any time before the
project commences, dual submission allows the governance and ethical review to occur in parallel. Your HREC
approval is not sufficient to start the study. A final endorsement letter will be provided for the SSA only where
HREC approval is obtained and the letter provided to the RGO.
Partially completed (unsigned/invalid) applications will be returned Via the GEMS system as ineligible for you to
correct or provide the required corrections and then resubmit via GEMS.
Please contact the RGO if you anticipate a lengthy delay in submitting an SSA.
Contact Us
The team at the Research Secretariat are happy to assist you in navigating the necessary documents and
processes outlined in this guide, and to give advice on project-specific information.
Contact us on +61 8 8182 9346 or healthNALHNrgo@sa.gov.au
For more information
NALHN Research Secretariat
Lyell McEwin Hospital
Level 2 Clinical Trials Unit
Haydown Road
ELIZABETH VALE SA 5112
(08) 8182 9346
email: healthNALHNRGO@sa.gov.au
sahealth.sa.gov.au/nalhn
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