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, eg 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).
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
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 completeing the HREA)
- Cover letter (please include a list of all the sites this HREC will be responsible for, including private sites)
- 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.
- Investigators Brochure (IB)/product information
- Any other participant specific documents – questionnaires, study diary, ID Cards, instruction guides etc
- Other documents relevant to the study (such as; RDMP, 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) – 3 signed hard-copy originals + 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) – 3 signed hard copy originals + 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) – 2 or more originals-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:
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. CLINICAL TRIAL METRICS
8. FORMS AND TEMPLATES
9. DATA MANAGEMENT FOR RESEARCH
10. ADVERTISEMENT OF UNAPPROVED GOODS
11. TRAINING AND SUPPORT
12. DATA SAFETY MONITORING BOARDS (DSMB)
Clinical Trials Executive Officer
Research Ethics & Governance Office
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
(please contact us for details)