Additional ethics requirements

Good Clinical Practice (GCP) Certificate

The Guideline for Good Clinical Practice (GCP) is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. GCP compliance is a condition of approval for the conduct of a clinical trial.

A GCP Certificate is required as evidence of completion of a certified GCP course for the Coordinating Principal Investigator (CPI) and site Principal Investigators (PIs) if conducting a clinical trial.

• ICH Guideline for Good Clinical Practice (GCP)
• Good Clinical Practice courses

Investigator’s Brochure (IB)

The IB is a compilation of the clinical and nonclinical data for the investigational product(s) being trialled in the study and provides the rationale for key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures.

The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice Section 7 Investigator’s Brochure sets out the minimum investigational product information requirements for all drug and/or device clinical trials.

• ICH GCP Section 7 Investigator’s Brochure
• IB for medical device clinical trials

Clinical Trial Notification (CTN)

Clinical trials involving the use of therapeutic goods are subject to various regulatory controls under the therapeutic goods legislation to ensure participant safety. The Australian Register of Therapeutic Goods (ARTG) is the public database of therapeutic goods that can be legally supplied in Australia.

Clinical trials that involve the use of ‘unapproved’ therapeutic goods, including use of an approved drug or device in a manner (dose or cohort) that is not ARTG approved, must register using the Clinical Trial Notification (CTN) scheme. The CTN Scheme is a notification process to the Therapeutic Goods Administration (TGA).

CTN process

The process for CTN approval involves both ethics and governance. The eCTN registration is completed online and uploaded with the HREA via ERM for HREC review. When the HREC approval letter is received, the eCTN can be lodged with the TGA. Once received, the CTN Acknowledgement letter must be submitted to the Metro North research governance office via ERM either with the SSA submission or as a post authorisation notification (PAN) depending on the status of the clinical trial approvals. Refer to the Clinical trial notification (CTN) form – user guide for more information.

CTN registration details

Applications submitted to a Metro North HREC for ethical review must include the following CTN registration details:

Clinical Trial Agreement and Insurance

A clinical trial agreement will be required for all clinical trials conducted at a Metro North site. While the clinical trial agreement is not submitted for HREC review, Metro North encourages parallel review and submission of ethics and governance applications. Early planning with all participating sites for completion of the clinical trial agreement will assist with ethical and governance review and support an efficient study start-up.

• Clinical trial agreement and insurance

Teletrials

A teletrial is a clinical trial that is delivered closer to home, particularly for regional, rural and remote patients. It includes groups of clinical trials sites that work together under the supervision of Principal Investigator as the Primary Site. A cluster is a group of two or more sites conducting the same trial.

The Australian Teletrial Program aims to improve regional, rural and remote patient access and participation in clinical trials through proven teletrial models and digital communications to connect clinical trial sites. The Australian Teletrial Program provides a suite of teletrial resources for evaluating a trial site, study start-up checklists and essential teletrial documentation templates.

The National Teletrials Compendium supports a national approach to teletrials through the National Principles for Teletrials in Australia and the National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia. Compliance with the compendium provides assurance to the public that clinical trials protect the rights, safety and wellbeing of participants and the data generated from clinical trials is credible.

• Australian Teletrial Program Resources
• The National Teletrials Compendium
• Queensland Health setting up a teletrial

Clinical trials registry

Under Section 19 of the Declaration of Helsinki (2008) “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” In addition, the International Committee of Medical Journal Editors (ICMJE) has made an essential criterion for publication of a trial in one of their journals that the details of a trial should be publicly available in a clinical trials registry.

While the clinical trial registration number is not required for ethical review, please be aware the trial registration process can take up to 8 weeks so consideration of this step and early registration at the time of ethical approval will assist with efficient study startup.

The two primary clinical trials registries are:

• Australian New Zealand Clinical Trials Registry (ANZCTR)
• ClinicalTrials.gov – For clinical trials involving a US site