Integra Trials operates to the regulatory, ethical and operational standards that protect trial participants, satisfy auditors, and give sponsors confidence in the data we deliver.
The standards below are not a marketing claim; they are the operating framework that every trial we run is required to meet. Documentation of compliance is available to sponsors and regulators on request.
Trials are conducted only after the required HREC approval, site authorisation, trial-specific insurance, and applicable TGA notification or approval requirements are in place.
The International Council for Harmonisation Good Clinical Practice (ICH-GCP) E6(R2) guideline is the international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. Integra staff working on trials are trained in ICH-GCP, and our standard operating procedures are written against it.
Clinical trials in Australia operate under the regulatory framework of the Therapeutic Goods Administration (TGA). Integra is set up to support sponsors running trials under both the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes, and our processes are aligned to the TGA's expectations for trial site conduct, safety reporting, and product handling.
Every trial we conduct is reviewed and approved by a registered Human Research Ethics Committee (HREC) before any participant is enrolled. HREC review is independent of the sponsor and the research team, and provides external assurance that the trial design, consent process, and participant protections meet Australian ethical standards.
Our facility is registered as a trial site under Bellberry Limited's HRECs. The relevant HREC contact details for any given trial are included in the Participant Information and Consent Form.
We operate in line with the National Statement on Ethical Conduct in Human Research issued by the National Health and Medical Research Council (NHMRC), together with the Australian Code for the Responsible Conduct of Research. These set the national expectations for the ethical design and conduct of research involving people.
Personal and health information collected through enquiries and trial participation is handled in accordance with the Privacy Act 1988 (Cth) and the Australian Privacy Principles. Health information is treated with particular care and only shared with the clinical team involved in your potential care, or with sponsors and regulators where required.
Full details are set out in our Privacy Policy.
Integra maintains clinical trial site insurance covering our site operations. Each trial additionally requires trial-specific insurance arranged by the sponsor (covering the study, the investigational product and participants) which must be in place before the trial can commence at our site. Source data, regulatory files and standard operating procedures are maintained in inspection-ready form to support sponsor monitoring and regulatory inspection.
If you have a concern about how a trial has been conducted, please see our Complaints Procedure.
Sponsors, monitors, ethics committees, and regulators can request site files, SOPs, training records, insurance certificates, and other compliance documentation. Patients and family members are also welcome to ask for any documentation relevant to a trial they're considering joining.
Requests can be sent to:
Email: info@integratrials.com.au
Post: Integra Trials Ltd, CIS Monash Clinic, Level 1, 52–54 Monash Ave, Nedlands WA 6009