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Clinical Trials Unit  

Site Information Guide  







          Lyell McEwin Hospital 

2 LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 


Clinical Trials Unit  3 

Staff 4 

Unit facilities 5 

Equipment 5 

  Equipment Maintenance and Calibration 5 

Confidentiality Disclosure Agreement  6 

Site Feasibility 6 

Site Selection Visit 6 

Indemnity 6 

Clinical Trials Research Agreement  7 

Clinical Trials Notification 7 

Clinical Trials Unit Fees 8 

Withholding Fee 9 

Overhead Policy 9 

SA Health Pharmacy  LMH 10 

       Location 10 

       Contact 10 

       Fees 10 

Research Governance Office  10 

       Dual submission 10 

       Fees 11 

SA Medical Imaging 11 

       Fees 11 

SA Pathology 11 

       Anatomical pathology 11 

       Fees 11 

Site Monitoring 12 

       Monitoring Visit preparation 12 

       Remote Monitoring 12 

       Audits 12 

       Close Out Visit 12 

Document destruction 12 

Archiving 12 

Clinical Trials Unit Location  13 

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 3 


Clinical Trials Unit 



Thank you for taking the time to consider the Lyell McEwin Hospital (LMH) Clinical Trials Unit (CTU) as a 

potential study site for your research project.  

The following information is provided to assist you in the site selection. 

The Lyell McEwin Hospital is part of the Northern Adelaide Local Health Network (NALHN) that provides 

care to more than 400,000 people living in the northern metropolitan area of Adelaide as well as people 

in regional area. LMH is recognised as a leading teaching institution which has affiliations with the 

University of South Australia, Flinders University and The University of Adelaide. 

LMH is an accredited institution that complies with the 10 National Safety and Quality Health Services 

Standards. The LMH currently services the area of highest population growth in the South Australia. 

At the LMH various health disciplines have been successfully involved in the conduct of clinical trials for 

more than 20 years. As the hospital capacity and demand in clinical trials have grown, the CTU was 

formally established in 2016. 

The CTU runs Phase II   IV clinical trials for many of the world s leading pharmaceutical and 
biotechnology companies. We uphold stringent observation of the international regulatory requirements 

that facilitates the practice of the highest standards in clinical research. The unit has an extensive 

portfolio of over 40 active trials in a broad range of therapeutic areas. 


We have extensive experience in the following: 

? Use of various Electronic Data Capture (EDC) systems 

? Administering Patient Reported Outcomes (PROs) questionnaires (paper and tablet based) 

? Obtaining ECGs  

? Vital signs assessments 

? Intravenous Infusions 

? Collection, processing and shipping of biological samples 

A dedicated team of highly trained and experienced staff including medical personnel and registered 

nurses are involved in coordinating and conducting the clinical trials in the following disciplines: 

? Endocrinology 

? Gastroenterology &amp; Hepatology 

? Psychiatry 

? Cardiology 

? Renal 

? Respiratory 

? Rheumatology  

? Infectious Diseases 

The LMH has dedicated Cancer Clinical Trials Unit that specialises in various Oncology Trials.  


For further information, please contact: 

Victoria Tsagareli 

Clinical Trials Unit Manager 

Email: Health.LMHClinicalTrialsUnit@sa.gov.au 

Phone: +61 (08) 8282 0219 

CTU Address: 

Lyell McEwin Hospital Level 

2, Clinical Trials Unit 

Haydown Road 


LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 4 



CTU complies with SA Health Policy, Procedures and Guidelines and clinical trials are conducted 

under current ICH/GCP and NHMRS guidelines.  

Medical Staff - Consultants 

Name Experience in Research (years) 


A/Prof Peak Mann Mah 

Dr Parind Vora 

Dr Linda Watson 

Dr Jessica Stranks 

&gt; 10 

&gt; 5 

&gt; 5 

&gt; 5 




A/Prof Dennis Liu 

Prof Cherrie Galletly 

Dr Anna Nowak 

&gt; 10 

&gt; 10 

&gt; 5 



A/Prof Margaret Arstall 

Dr Purendra Pati 

Dr Sharmalar Rajendran 

Dr Alicia Chan 

Dr Rajiv Mahajan 

Dr Devan Mahadavan 


 &gt; 5 

 &gt; 5 

 &gt; 5 

 &gt; 5 

 &gt; 5 



Dr Damian Harding 

Dr Asif Chinnaratha 

Dr Derrick Tee 

Dr Hamish Philpott 

Prof Rajvinder Singh 


 &gt; 5 

 &gt; 5 

 &gt; 10 

 &gt; 5 

 &gt; 5 


Dr James Geake  &gt; 5 

Trial Staff 


Name Position 

Victoria Tsagareli Clinical Trials Unit Manager 

Jane Rose  Clinical Trials Coordinator 

Bernie Hoffmann Clinical Trials Coordinator  

Brenda Trezona Clinical Trials Coordinator  

Beverley Hisee Clinical Trials Coordinator  

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 5 


Unit Facilities  

? Reception / Waiting area  

? Three fully equipped clinic rooms designated for trial assessments / procedures 

? Facilities for clinical trials monitoring  

? Fully equipped Laboratory  

? Secure Storage Rooms  

? Conference Room  

? Shared Kitchen facility 


The following equipment is available at the site for the clinical trials: 

? ECG machine 

? Blood Pressure Monitors  

? Ophthalmoscope  

? Scales 

? Stadiometer 

? Thermometer (tympanic) 

? Glucometer  

? Fibroscan 

? Accurate measuring device for distance (6 minute walk test) 

? Fridge (-200C) and freezer and (-700 C) fully monitored and alarmed 

? Centrifuges (refrigerated and ambient) 

NOTE: The Clinical Trials Unit is unable to supply or source dry ice for shipping of frozen 

laboratory samples. It is the sponsors  responsibility to select a courier service that is able to 

provide dry ice on a day of sample collection  

Equipment Maintenance and Calibration 

As part of a state-wide policy, each piece of equipment is risk-assessed by the Biomedical Engineering 

(BME) Department based on their use and potential for malfunction.  In 2018, South Australian BME 

developed a process aligned with Australian standards to meet legislative requirements. Maintenance 

and calibration is based on a formal risk assessment analysis according to the Australian Standard 3551 

and therefore, no calibration certificates are provided. Each piece of CTU equipment is labelled with a 

yellow sticker stating  This device is NOT scheduled for maintenance .  


Special requests for calibration and maintenance may be made. 


LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 6 


Confidentiality Disclosure Agreement 
Confidentially Disclosure Agreement (CDA) is a mutual document between a sponsor and the CTU that 

protects any confidential information to be disclosed to a third party by either side .The mechanism to 

protect the confidential information is the execution of the CDA by both parties. 


A CDA template approved by the Crown Solicitors Office for the SA Department for Health and Aging 

must be used and is available on request. Initial CDA should be forwarded to the Clinical Trials Unit 

Manager for execution through the Institution, prior to disclosing any trial related confidential material.  


At the LMH, a CDA is executed by the Executive Director of Medical Services on behalf of the Institution 

and other staff / Investigators. The agreement must be addressed to the Institution and not to any 

Individual/s as follows: 

 Northern Adelaide Local Health Network Incorporated operating as Lyell McEwin Hospital  

(ABN 46 371 200 573) of Haydown Rd Elizabeth Vale South Australia 5112, Australia  


The institution will not be held accountable to the laws of other jurisdictions. The following statement has 

been approved by the Crown for inclusion in the CDA: 



 This Agreement shall be governed and construed in accordance with the laws and regulatory 

requirements of the State of South Australia and the Parties agree to submit to the exclusive jurisdiction 

of the courts of that State and the courts of appeal from them . 


Site Feasibility Assessment 

A site feasibility questionnaire should be emailed to the potential Principal Investigator and Clinical Trials 

Unit Manager. Please email to Health.LMHClinicalTrialsUnit@sa.gov.au 


Site Selection Visit 

Site Selection visits should be scheduled with the Clinical Trials Unit Manager in advance.   


At the visit, you will be meeting with the following staff: 

?   Principal Investigator 

?   Clinical Trials Unit Manager 

?   Study Coordinator 

?   Onsite Pharmacy (if required)  


??If the sponsor is new to the CTU, a tour of our facility can be arranged on request. 


SA Health has standard insurance and indemnity arrangements that apply to the whole of the 

Government sector, including public hospitals. SA Health has adopted the Medicines Australia indemnity 

position set out in the Standard Medicines Australia Indemnities. As this position has long been accepted 

as the appropriate standard by both Government and industry, clauses that seek to alter or re-state this 

indemnity position will not be agreed to.  

Standard Indemnity template is available on request.   

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 7 


Clinical Trials Research Agreement 

The Standard Clinical Trails Research Agreement (CTRA) reflects a fair and reasonable commercial 

agreement between the contracting parties. The purpose of the Standard CTRA is not to delete or to 

modify essential clauses that have been subject of long negotiation with Medicines Australia and, 

through them, the pharmaceutical industry. Accordingly clauses that seek to substantially alter the core 

provisions of the agreement will not be agreed to. This includes and not limited to the following clauses: 

the publication, the confidentiality, the intellectual property and termination provisions.  

Standard CTRA template is available on request.  

Site specific details must be included as follows: 

Site Details  

Name of Institution 
Northern Adelaide Local Health Network Incorporated,  

operating as Lyell McEwin Hospital 

Clinical Trials Unit, Level 2 
Haydown Road, Elizabeth Vale, South Australia 5112 

ABN 46 371 200 573 

Contact for Notices Clinical Trials Unit Manager 

Phone Number +61 8 8282 0219 


Schedule 2 - Payee Details 

Bank Commonwealth Bank of Australia 

Branch 96 King William St, Adelaide 5000 

BSB 065 266 

Account Name NALHN Oracle Operating 

Account Number 1002 0646 

ABN 46 371 200 573 

Swift Code CTBAAU2S 


Amendments to Schedule 7 or Schedule 4 of the CTRA require SEBS approval. 


After negotiation of a mutually acceptable budget has been reached, the draft version of the CTRA will 
be submitted to the NALHN LMH RGO for their final review and approval. The sponsor should provide 
three wet ink signed copies to the site for the final execution. 


Clinical Trials Notification 

For sponsors submitting electronic Clinical Trials Notification (eCTN) for clinical trials being conducted at 

Lyell McEwin Hospital the approving authority information is below: 

Name of Approving Authority 
Northern Adelaide Local Health Network Incorporated  

operating as Lyell McEwin Hospital 

Contact Name Roy Sneddon and / or Lorraine Cichon 

Position Research Governance Officers 

Phone +61 8 8182 9346 

Email HealthNALHNRgo@sa.gov.au 

The CTN can be submitted prior to governance authorisation and a copy of the TGA acknowledgement 

provided with the governance application or post authorisation.  

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 8 


Clinical Trials Unit Fees 



*CTU Start Up Fee $5000 (one off fee to be invoiced upon CTRA execution) 

**Monthly Administration Fee 
$200  (monthly until the close out visit,  
             to be invoiced quarterly after Site Initiation Visit) 

Participant Re-Consent Fee  $160  (if occurs at next scheduled visit) 

Participant Re-Consent Fee  $300  (if outside a regular scheduled visit) 

Initial RGO Submission  $2000 (SSA form and initial submission) 

RGO Amendment Submission Fees  

? Major Amendment  $300 (per submission) 

? Minor Amendment  $150 (per submission) 

SAE Reporting $250 (per occurrence) 

Close-Out Fee $600 

Remote Close-Out Fee $1200 

Remote Monitoring Fee $230 (per instance) 

  Archiving Preparation Fee (boxing etc)      $500  

  Archiving Storage Fee  $1800 (one off) 

Audit Fee $1000 (per day) 

Participant travel and meals To be negotiated 

Advertising  If required  

Trial relating mandatory training  To be invoiced (per staff member/per hour)  

Investigator Meeting attendance To be negotiated 


If CTU is a Lead Site (in addition to above)  

CTU Initial HREC Submission Fee $2600  

? additional site listed in original submission $300 (per site inclusion fee) 

? additional site listed after approval $600 (site addition fee) 

Ongoing Monthly Administration Fee $320 (monthly until the close out visit, to be invoiced 
quarterly from Site Initiation Visit date) 

Additional HREC submissions  

? Major Amendment  $400 (per submission) 

? Minor Amendment  $200 (per submission) 


Low Negligible Risk Trial submission Please contact the site for fees 


Miscellaneous Fees 
Will be added according to the protocol 

? Local Laboratory - trial set up Refer to page 12 

? Imaging Department - trial set up Refer to page 12 


LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 9 


The CTU fees are based on the standard costs for conducting clinical trials in Australia. 
*Study Start-Up Fee includes activities relating to the following: 

Site preliminary assessment including signing the confidentiality disclosure agreement, protocol 
review, feasibility determination, discussion and negotiations with external staff &amp; relevant 
departments, accommodation of the Site Selection Visit and staff attendance (PI, SC and the 
Manager) , budget negotiation, CTRA execution, Site Initiation Visit (PI, Sub-I, SC, back-up SC and 
the Manager), equipment set up, source documents creation and pre-screening/recruitment activity. 


**Monthly Administration Fee incorporates the cost of daily study related activities after site 

activation including but not limited to:  

? Ongoing liaison with Clinical Research Associate (CRA) and/or sponsor or their representatives  

? Invoicing  

? Maintaining study source documents, Investigator Site Files (ISF) and study supplies  

(e.g. central laboratory kits/storage/re-order and destruction) for the duration of the study.  

? Review of safety reports and ongoing communication  

? Maintaining temperature logs  

? Accommodating CRA visit  

? Trial specific equipment maintenance  

? Consumables relating to the trial: use of computers, internet, fax and printer related costs 

? Secure storage of ISF, source documents, study equipment and supplies for the duration of the 


Research Governance Office (RGO) / HREC preparation fees incorporate the following:  

? Minor amendment (submission of documents with administrative changes, annual reports, 

SAEs, SUSAR/USAED reports, sponsor notifications, close out report etc)  

? Major amendment (submission of either new version of IB, protocol and / or Participant 

Information Sheet / Informed Consent Forms (PIS/ICF) and site specific versions of PIS/ICF). 

Trial Related Mandatory Training Fee relates the following but not limited to: 

? GCP Online training / certification  

? IWRS portal access / certification 

? Trial specific technology use (e.g. tablet, smart phones, iPad) 

? eCRF completion /certification 

? IP administration /  certification 

? Webinar requests 

? Teleconferences 

? Protocol amendments 

? Laboratory  

? Licencensed questionnaire administration / certification 

? Training for specific procedures 

? Re-training 

The site must be reimbursed for trial related training activities that occur outside the training provided 

at the Investigator Meeting, Site Initiation Visit or at any time after the site has been activated or 

throughout the trial. 


Withholding Fee 
The Clinical Trials Unit operates on cost recovery model and cannot accept fee withholding schedule. 

Overhead Policy 

NALHN requires a 25%OH to be applied to per participant fees (not site fees) for operating expenses 

of running / maintaining the Clinical Trials Unit.  

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 10 


SA Health Pharmacy LMH  

Investigational Drugs Pharmacy 

Lyell McEwin Hospital 

Level 1, Haydown Road 

Elizabeth Vale    SA   5112  


Email: Health.LMHClinicalTrialsPharmacy@sa.gov.au 


Fees are depending on the Investigational product constituent, preparation and dispensing instructions. 

Human Research Ethics Committee  

For clinical trials to be conducted at the Lyell McEwin Hospital, the affiliated central HREC is the Central 

Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)   EC00192. 

Please refer to the CALHN HREC website for all relevant details (submission dates, current fee schedule, 

documents, templates etc). 

Website: https://www.rahresearchfund.com.au/rah-research-institute/for-researchers/human-researchethics/ 


  For more information, please contact:  

  Ian Tindall 

  HREC Chairman 

  Email: Health.CALHNResearchEthics@sa.gov.au  

  Phone: +61 8 8222 4139  


Research Governance Office  
For clinical trials to be conducted at the Lyell McEwin Hospital, the affiliated Research Governance Office 

is the Northern Adelaide Local Health Network Research Governance Office (NALHN LMH RGO). 

The information about NALHN RGO is available at the following website: 




For more information, please contact:  
Roy Sneddon or Lorraine Cichon 

  Research Governance Officers  

Email: healthnalhnrgo@sa.gov.au 

Phone: +61 8 8182 9346 


Lyell McEwin Hospital   

Level 2, Clinical Trials Unit   

Haydown Road 



Dual Submission 

NALHN supports dual submission of ethics and governance. Dual submission allows the governance and 
ethical review to occur in parallel.  

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 11 



The Schedule of Fees and the RGO Fee form are available for download from the following website: 


SA Medical Imaging  
The Medical Imaging Department provides services for research across the Lyell McEwin Hospital. 

Imaging modalities and services include: 

? X-ray 

? Computed Tomography (CT) 

? Magnetic Resonance Imaging (MRI) 

? Ultrasound 

? Mammography 

? Coronary Angiography 

? Digital Imaging (PACS) 

? Nuclear Medicine 

? Bone densitometry 

? Digital Imaging (PACS) 

? PET   CT can be performed at other providers, if required. 


Radiology Setup fee 

MRI Setup fee $1000 

MRI Image de-identification and digital transfer to any electronic device $70 

MRI Image transfer fee $50 

Medical Scientist Radiology Exposure report $400 

PET scan Set Up fees  TBC 


The imaging required for a clinical trial will be classified as  additional to standard of care  and billed to 

the Clinical Trial Unit.  Exceptions to this are if the imaging is unable to be billed to Medicare   e.g. Non 

rebateable MRI scans. 


SA Pathology 

SA Pathology is the state-wide pathology provider for the public health sector. 

Local laboratory results are ordered and reviewed electronically for clinical assessment copies of lab 

reports will be printed and certified by the Investigator retrospectively for source verification. 


Anatomical Pathology 

In accordance with SA Pathology regulations, tissue blocks cannot be provided. Sponsor to organise,  

if required. Biopsy tissue is provided on slides (stained or unstained) as required.  


SA Pathology Trial Set up fee of $500 and lab test fee per item are applicable.  

Lab test fee will be charged per nominated item and at 140% of the MBS prescribed fee.  

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 12 


Site Monitoring  
For privacy and confidentiality the Clinical Trials Unit has available two separate monitoring rooms and a 

conference room. To book a monitoring visit, please contact the Clinical Trial Coordinator and arrange a 

mutually agreeable date and time for the visit. If you wish to meet with the Principal Investigator, please 

request it in advance. 

Monitoring Visit Preparation 
All source documents at the LMH are in paper format. Please request the medical records to be 

reviewed by providing a list to the Study Coordinator at least 1 week prior to your visit. The Study 

Coordinator will arrange for the medical records to be available for your visit. Please note that medical 

records may be unavailable at any given time during your visit due to preexisting appointments, accident 

&amp; emergency attendance or inpatient admissions.  

At the end of monitoring visit the trial monitor is responsible to hand over all medical records, 
Investigator Site Files and source documents in complete order to the Study Coordinator. The 
monitoring room should be left in clean state for the next user. 

If a visit with pharmacy is required, it is trial monitor s responsibility to schedule an appointment with the 
clinical trial pharmacist. Please email Health.LMHClinicalTrialsPharmacy@sa.gov.au to arrange a 

mutually agreeable time. 

A photocopier / scanner is available in the unit for use.  

Please note that computer or Internet access is not provided due to hospital policies. 

Remote Monitoring 
Any work completed to support offsite monitoring activities etc. collation, de-identification and provision 

of source documents, collation and provision of essential documents or ISF reconciliation will be 

supported at a cost to the sponsor of $230 per instance. 


Written notification to the institution is required prior to attendance and will include the agreed date of the 

audit, the auditor(s) attending and an agreed visit schedule. 

Close Out Visit 

Close out visits can be booked by contacting the Study Coordinator. The Study Coordinator will ensure 

required site staff are available and retrieve all study materials for the visit. 

Document Destruction 

The documents that require destruction must be handed over to the Study Coordinator for further action. 

Confidential material will be disposed of in locked container which is collected and shredded by a 

contracted company.  


Once a clinical trial has closed out and the necessary HREC and RGO notifications have been 

performed and acknowledged, study files will be archived offsite at Iron Mountain.  

Iron Mountain is an offsite storage provider located at 160 Churchill Road North, Cavan SA 5094. 

LMH Clinical Trials Unit Site Information Guide, Version 1, 08 Jan 2020 13 


Clinical Trials Unit Location 
Lyell McEwin Hospital  

Level 2, Clinical Trials Unit 

Haydown Road 




The Clinical Trials Unit is located within the Lyell McEwin Hospital. If you plan to visit us, we highly 

recommend you to print a copy of the map below, as we want to make it as easy as possible for you to 

find us. 


If you need guidance in finding us, please contact the CTU staff on 8282 0219.