Document information

Human Research Ethics Application (HREA)

&

WA Specific Module (WASM)

HREA (external site) is a streamlined ethics application using dynamic content and help to assist researchers consider and address the principles of the National Statement on Ethical Conduct in Human Research.

The HREA is not available electronically in RGS. If ethical review is by a WA Health HREC, the HREA must be completed via the NHMRC HREA website and uploaded to RGS as a pdf supporting document. There is no need to attach supporting documents to the HREA (on the NHMRC website) as they should be uploaded separately into RGS. If ethical review is by an NMA non-WA Health HREC, the HREA should be completed via the state/territory Governance application site. Please ensure all sites involved in the research project are listed in the HREA form.

WASM (PDF) addresses WA legislative requirements. It is completed in conjunction with the HREA for health and medical research projects conducted within WA or intending to access WA participants, tissue / data.

AR Form is used instead of an SSA where the study is collecting data or information but the research is not being carried out on the site.

1. participant recruitment through staff distributing posters, leaflets, handouts, and letters of invitation (but does not involve participant recruitment.)
2. distribution of surveys and questionnaires to personnel of the site by e-mail, in line with the site policies (but not collation and analysis of responses at that site.)
3. access to medical records, data or tissue held in the site collections or databases under their management, in line with ethical conditions set out by the approving HREC (but not processing or analysis at that site).

In addition to the AR Form, for projects requesting access to the Department of Health data collections the investigator must submit an Application for Data Form (external site)

RG determines whether to allow access to its participants, their tissue or data when a research project is not being conducted at the site.

When a study requires access across multiple sites within the jurisdiction of the same RG Office, then details regarding these sites may be documented on one AR Form, though a declaration of authorisation will be required from each site involved. In WACHS the Regional Director must also provide a declaration.

A research protocol is the guide for a research study. The protocol describes in detail what the researchers are intending to do and how they will do it. In writing a protocol all the major issues are considered in design and development of a particular research project.

Clinical Trial Protocol (suggested template) (external site)

A protocol will include the following as a minimum:

• Background summarising the related literature and the justification for carrying out the study.
• Inclusion and exclusion criteria for participant enrolment.
• Study hypothesis or hypotheses
• Aims and objectives
• Intervention / Procedures - what will be done and how it will be done.
• Study Conduct with a level of detail for others to know exactly how to run the study and the required resources.
• Data to be collected and how it will be analysed.
• Safety management describing any study-related safety and security measures.

Non Clinical Trial Protocol (suggested template) (external site)

Projects not classified as Clinical Trials may include,

• Recruitment
• Procedures
• Intervention

They will usually not involve assessments of the efficacy/safety of drugs or other therapeutic or investigational products (including medical devices).

1. Participant Information Sheet and Consent Form (Master)

1. A combined information and consent form in a multi-centre study where the lead site creates the study PICF and a Master version is provided to all other sites to add in local details.

2. OR Participant Information Sheet (Master) / Participant Consent Form (Master)

2. As above except there are two separate documents.

3. AND/OR Participant Information Sheet and Consent Form (Site Master)

3. Often used in multi-centre commercial studies - A combined information and consent form for a site where the sponsor has already created an Australian master version for submission to a lead HREC as part of the National Mutual Acceptance. They will then forward to each site for a local ‘Site Master’ version to be created and submitted to Governance.

Any study document being used/completed by participants must be reviewed by ethics.

Please note some international questionnaires require approval to be used by the international group such as EQ-5D-5L.

Data Application Form

Data linkage is a technique for connecting pieces of information that are thought to relate to the same person, family, place or event. Linked data is used in Western Australia to support approved research, develop policies, plan services and evaluate services. This provides a more complete picture of the health of people in WA.

www.datalinkage-wa.org.au (external site)

Investigator’s Brochure (IB)

The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to ensure their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study participants during the clinical trial. The information should be presented in a concise, simple, objective, balanced, and non-promotional form. A medically qualified person should generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that generated the described data.

Contracts

1. AND/OR Service Agreement

WA Health uses Medicines Australia CTRA templates. (external site)

1. A CTRA is a legally binding agreement that set out the relationship between the sponsor, the financial support and/or proprietary information and the institution that may be providing data and/or results, publication, input into further intellectual property.

2. OR Funding Agreement

2. Funding Agreement – a contract between the institution and the research organisation where the organisation has agreed to contribute to the funding of the research.

3. AND/OR Material Transfer Agreement (MTA)

3. MTA – Where the institution has agreed that a third-party organisation (hospital/university) can receive certain study materials (tissue and/or fluids) obtained during the study for use in ethically approved clinical research.

4. Clinical Trial Research Agreement (CTRA aka CTA)

4. Service Agreement – Where WA Health is either providing or receiving a service with associated payments.

1. Participant Information Sheet and Consent Form (Master)

1. A combined information and consent form in a multi-centre study where the lead site creates the study PICF and a Master version is provided to all other sites to add in local details.

2. OR Participant Information Sheet (Master) / Participant Consent Form (Master)

2. As above except there are two separate documents.

3. AND/OR Participant Information Sheet and Consent Form (Site Master)

3. Often used in multi-centre commercial studies - A combined information and consent form for a site where the sponsor has already created an Australian master version for submission to a lead HREC as part of the National Mutual Acceptance. They will then forward to each site for a local ‘Site Master’ version to be created and submitted to Governance.

RGS templates (external site)

Which clinical trial scheme should I choose? (external site)

This tool helps Australian trial sponsors (external site) determine whether the CTN or the CTA scheme is most appropriate for their clinical trial.

If you are carrying out an investigator-led study the Research Governance office will assist with the CTN or CTA submission on behalf of the study sponsor. (See TGA CTN GUIDELINES MASTER COPY v1.0 02.09.15.)

Clinical Trial Notification (CTN)

(Drug or device study)

OR

Clinical Trial Approval (CTA) Documentation

(Drug or device study)

CTN – under the Therapeutic Goods Administration Act 1989 and Regulations, notification under the CTN Scheme (or application under the CTX Scheme) is required for:

• any medicine or device not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or
• the use of a registered medicine or device beyond the conditions of its marketing approval, including new indications extending the use of the product to a new population group and the extension of doses or duration of treatments outside the approved range.
• Researcher: The person responsible for the conduct of the clinical trial at a trial site.
• HREC: Responsible for assessing the scientific validity of the trial design, the safety and efficacy of the medicine or device and the ethical acceptability of the trial process, and for approval of the trial protocol.
• Approving Authority: The institution or organisation at which the trial will be conducted gives the final approval for the conduct of the trial at the site.
• Sponsor: The company, organisation, institution, body or individual (enterprise) that takes responsibility for the overall conduct of the trial. Notifies the TGA using the CTN form and paying the appropriate fee.

CTA scheme forms | Therapeutic Goods Administration (TGA) (external site)

CTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor and sent to us via clinical.trials@health.gov.au If you require a CTA

• Part 1: The Application
• Part 2: Notification of the conduct of a trial under the CTA scheme

RGS templates (external site)

For commercial clinical trials, sponsors (or the contract research organisation) are required to provide the relevant Medicines Australia Form of Indemnity for Clinical Trials. These forms reference the 'Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Clinical Trial' which the sponsor agrees to adhere to if injury is suffered by a participant while participating in the Study (project). Investigators must make it clear to the participants that the project is being conducted subject to those Guidelines.

For commercial clinical investigations, sponsors (or the contract research organisation) are required to provide the relevant Medical Technology Association of Australia Standard Indemnity Form for a Clinical Investigation.