Clinical Trials

A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing, e.g. a drug, a device, a surgical or other therapeutic procedure, a preventative procedure or a diagnostic procedure.

The Sydney Local Health District (SLHD) HREC – RPAH is certified under the National Mutual Acceptance scheme to review all phases of clinical trials (phase 0. I, II, III and IV).  However, Early Phase Clinical Trials (studies up to but not including Phase II or with a Phase I component) must be submitted to Bellberry HREC, who have been appointed under the NSW Health Early Phase Clinical Trial Scheme to review adult EPCT applications that will be conducted at NSW Public Health Organisation institutions.

For further information on submitting Early Phase Clinical Trial applications, please refer to: https://bellberry.com.au/im-a-researcher/multi-centre-trials/nsw-pho-epct/nsw-early-phase-clinical-trial-framework/

If you are unsure what phase your project is, please refer to the NSW EPCT quick reference guide for further guidance and contact the Clinical Trials Executive Officer at SLHD-RPAEthics@health.nsw.gov.au

 
Important note:

• Meeting dates for Clinical Trials Sub-Committee
  
  
• Pre-meeting application check opens a week before the closing date.  The office strongly encourages applications to be submitted before the closing date for a pre-meeting application check.
  
  
• Researchers are also encouraged to attend the monthly drop in clinics.  For clinic dates, visit: https://www.slhd.nsw.gov.au/rpa/research/DropInClinicDates.html
  
  
• SSA applications may be submitted at any time via REGIS. Please note, it is important to liaise with the relevant Heads of Department and Supporting Departments (Pharmacy, Imaging, Medical Records) prior to submitting the SSA to ensure they are able to sign-off in REGIS. Do not submit the SSA if you have not consulted with the relevant departments and without ensuring CTRA and other contracts are ready for sign-off. See the SSA How to Apply page for further information or contact the Research Governance Officer.
   
• RPAH only: For studies involving drugs, researchers are required to liaise with the RPA Investigational Drugs Unit (IDU) prior to submitting the Protocol for review.  The IDU team can be contacted via SLHD-RPAPharmacyTrials@health.nsw.gov.au
  
  
• Studies involving cell therapy, gene therapy, somatic cell or tissue engineered medicinal products that are unlicensed Advanced Therapy Medicinal Products (ATMPs) without market approval and/or Class 4 biologicals under the TGA Australian Regulatory Guidelines for Biologicals (ARGB) (https://www.tga.gov.au/classification-biologicals) require early consultation with the Director of the Department of Cell and Molecular Therapies, Professor John Rasko.
  
  
• The Director of the Department of Cell and Molecular Therapies, Professor John Rasko may be contacted via the Department of Cell and Molecular Therapies at RPAH (https://www.slhd.nsw.gov.au/research/department_details.html?research=cmt) or via the RPAH Institutional Biosafety Committee (IBC) (gabrielle.osullivan@health.nsw.gov.au)
  
  
• Studies involving Genetically Modified Organisms (GMOs) require early consultation with the IBC, including exempt GMO dealings, OGTR licenced GMO dealings and GMO dealings reviewed by another IBC. Please see Institutional Biosafety Committee – How to Apply.
  
  
• Guidelines on regulatory requirements under the Gene Technology Act 2000 for human clinical trials involving genetically modified organisms (GMOs) can be accessed here. 
  
  
• For all NSW Health Pathology staff or researchers collaborating with NSW Health Pathology staff, services or facilities, additional requirements apply. Please click here for further information.
  
  
• RPAH only: All applications for new clinical products to be used at RPAH must also be reviewed by the RPA New Clinical Products Evaluation Committee (NCPEC).  The application form can be found on the Intranet via forms: http://slhd-intranet.sswahs.nsw.gov.au/RPA/forms/appForm_IntroClinProduct.pdf
  
  
• Sponsorship: A single, specified entity must be listed to take responsibility for the initiation, management, provision of insurance and indemnity, and/or financing of a clinical trial.  See: https://ichgcp.net/5-sponsor
  
  
• The Sydney Local Health District is unable to sponsor sites outside of the district without the prior review and approval of the Chief Executive. Further information about this should be directed to the SLHD Executive Research Manager via the Executive Officer
  
  
• For investigator-initiated clinical trials sponsored by the Sydney Local Health District (SLHD), the Research Governance Officer (RGO) will submit the online CTN Scheme Form on the Therapeutic Goods Administration (TGA) website. Local investigators should not create their own TGA Business Services (TBS) account.
  
  
• Auditing of clinical trials is an essential component of the clinical trials process. Research teams should arrange for regular audits of the documentation to ensure ongoing compliance with Good Clinical Practice and the National Clinical Trials Governance Framework. SLHD Researchers have available to them, access to a suite of Audit Ready tools and should contact the Clinical Trials Business Manager at SLHD-ClinicalTrials@health.nsw.gov.au for more information.

1. COMPLETING THE HUMAN RESEARCH ETHICS APPLICATION (HREA) FORM

A research proposal is submitted for review using the Research Ethics and Governance Information System (REGIS) website at: https://regis.health.nsw.gov.au/. (First time users of the site must create an account before proceeding).

The first step is to register your project in REGIS. More information is available here.

Once the project registration is complete, the Human Research Ethics Application (HREA) must be completed in REGIS. The HREA is used for all research submissions regardless of the level of risk and regardless of whether the research is single-site or multi-site. More information is available here.

Once the ethics application has been submitted, you can commence the Site Specific Assessment Application (NSW SSA) in REGIS. More information on completing an SSA application and obtaining Head of Department support is available here.

More information on submitting the SSA application is available here.


COMPLETING THE HREA FORM ON REGIS

Important notes:

1. During project registration a Co-ordinating Principal Investigator/Researcher must be selected. This is the person with overall responsibility for the research project at all sites. In the HREA this person MUST have the following responses:

•    Q1.9.10: “What is the position of this person on the research project?” must be answered as “Coordinating Principal Investigator”

•    Q1.9.11: “Does this person have authorisation to sign the application on behalf of all members of the research team?” must be answered as “Yes”.

2. When uploading document files onto REGIS during project registration, keep your electronic filenames as short as possible e.g. Protocol or PISCF. 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 a version number or date.

3. The supervisor of a student project should be listed as the Coordinating Principal Investigator/Researcher (CPI), not the student.

4. Please do not access the HREA from the NHMRC site

2. DOCUMENTS TO BE SUBMITTED (i.e. Upload to REGIS when completing the HREA)

·    Cover letter (please include a list of all the sites this HREC will be responsible for, including private sites). Use template cover letter provided here

·    SLHD Privacy Compliance Form (if requesting a waiver of the requirement to obtain usual Consent)

·    Clinical Trial Protocol (note: studies received without a protocol will not be approved). Please use preferred template here

·    Research Data Management Plan (RDMP)

·    Participant Information Sheet & Consent Form. For multi-site research this should be a Master Version from which all sites can prepare their own local version. It should contain a version number and date.

·    Separate Participant Information Sheet and Consent Form for genetic sub-studies.

• Investigator’s Brochure (IB) / Product information / Australian Register of Therapeutic Goods (ARTG) Summaries

·    Any other participant specific documents – questionnaires, study diary, ID Cards, instruction guides etc.

·     Current GCP Certificates of Completion for all listed investigators 

·    A Consumer Engagement Plan: The Protocol should include a brief statement of the team’s proposed plan to partner with consumers (refer to https://www.slhd.nsw.gov.au/rpa/research/Partneringwithconsumers.html)

Alternately, Researchers can complete the SLHD Consumer Engagement Plan if consumer engagement plans have not been described in the Protocol (e.g. If your Protocol has been provided by a pharmaceutical company)

·    Other documents relevant to the study (such as; DSMB Charter, Biospecimen Manual Handling, Governance policies etc.) 
NB: the HREC may request additional documentation to assist with their review.

·    For Clinical Trials involving sites in Victoria, a Victorian Specific Module (VSM) must be completed.

·    For Clinical Trials involving sites in Western Australia, a Western Australia Specific Module (WASM) must be completed.

·    For sponsored trials where the trial will be conducted at RPAH: Medicines Australia Form of Indemnity (Standard) – 1 electronically signed copy + the insurance certificate

·    For sponsored trials where Sydney Local Health District HREC – RPAH is the lead HREC: Medicines Australia Form of Indemnity (HREC Review Only) – 1 electronically signed copy + the insurance certificate.

·     Where Sydney Local Health District HREC-RPAH is the reviewing HREC and RPAH is a site for the trial, both Forms of Indemnity are required (You can find the Medicines Australia Forms of Indemnity here).

·     The indemnity documents must name Sydney Local Health District Level 11 KGV Building Missenden Road Camperdown NSW 2050 ABN 17 520 269 052 as the “indemnified party”.

·     For externally sponsored trials only: Medicines Australia Standard Clinical Trial Research Agreement (CTRA) – 1 electronically signed copy.  You can find the Medicines Australia standard CTRAs here.

·     For externally sponsored trials only: Insurance Certificate: The sponsor should provide evidence that it has appropriate and sufficient insurance to meet its responsibilities under the Medicines Australia Standard Indemnity. Sufficient evidence is a current certificate of insurance which covers the conduct of the relevant clinical trial in Australia and contains insurance cover for a minimum amount of AUD $20 million for any one occurrence and in the annual aggregate. The Insurance Policy must not contain an excess/deductible greater than AUD $25,000 per claim.

·     Site Specific Assessment (SSA) Form –Please see the Clinical Trials SSA Submissions page of the website for more information on the application process.

Please see below for information on:

1. SPONSORSHIP

2. INSURANCE & INDEMNITY

3. CLINICAL TRIALS NOTIFICATION (CTN) SCHEME

4. RESEARCH PROTOCOLS INVOLVING IONISING RADIATION 

5. RESEARCH PROTOCOLS INVOLVING GENETICALLY MODIFIED ORGANISMS (GMOs)

6. FEES RELATING TO CLINICAL TRIALS 

7. FORMS AND TEMPLATES

8. DATA MANAGEMENT FOR RESEARCH

9. ADVERTISEMENT OF UNAPPROVED GOODS

10. TRAINING AND SUPPORT

11. DATA SAFETY MONITORING BOARDS (DSMB)

12. TELETRIALS

13. GOOD CLINICAL PRACTICE

14. PARTNERING WITH CONSUMERS