Complaints Procedure
If something hasn't gone the way it should, we want to know. This page explains how to raise a concern, what to expect from us, and where to escalate if you remain dissatisfied.
Who this applies to
This procedure applies to anyone who has had contact with Integra Trials Ltd, including trial participants and their families, healthcare professionals, trial sponsors and members of the public.
Concerns can relate to any aspect of our work: clinical care, communication, the conduct of a trial, the handling of your information, or the behaviour of a member of our team.
How to raise a concern
You can contact us in whichever way is easiest:
By email: info@integratrials.com.au
By phone: 08 6118 5888
By post: Integra Trials Ltd, CIS Monash Clinic, Level 1, 52–54 Monash Ave, Nedlands WA 6009
Where possible, please include your name and contact details, a brief description of what happened, when it happened, and the people involved. If you'd prefer to raise a concern in person, we're happy to arrange a meeting at our clinic.
You can also ask a family member, carer, friend, or advocate to raise a concern on your behalf.
What you can expect from us
- Acknowledgement within 3 business days. We will confirm we've received your concern and let you know who is handling it.
- An honest review. A senior member of our team (independent of the people involved where practical) will look into what happened, speak to those involved and review any relevant records.
- A written response within 20 business days. We will explain what we found, what (if anything) we are doing differently as a result, and any further options available to you. If the review needs longer, we will keep you informed.
- No detriment for raising a concern. Raising a complaint will not affect the care or service you receive from Integra, or your ability to take part in current or future trials.
Confidentiality
Concerns are handled in confidence. Information you share will only be discussed with people who need to know in order to investigate and respond. Where information must be shared more widely (for example with a sponsor or regulator), we will discuss that with you first.
If you remain dissatisfied
If you are not satisfied with our response, you can escalate your concern to one of the bodies below, depending on the nature of the issue.
Clinical trial conduct or participant welfare
Each trial we run is approved by an independent Human Research Ethics Committee (HREC). For studies reviewed by Bellberry HREC, you can contact Bellberry Limited directly. The relevant HREC contact details are also provided in the Participant Information and Consent Form for your trial.
Medicines, devices, or therapeutic products
Concerns about a trial medicine, device, or therapeutic product can be reported to the Therapeutic Goods Administration (TGA).
Health services in Western Australia
The Health and Disability Services Complaints Office (HaDSCO) handles complaints about health and disability service providers in Western Australia.
Privacy and personal information
If your concern is about how we have handled your personal information and you are not satisfied with our response, you can lodge a complaint with the Office of the Australian Information Commissioner (OAIC).
Improving from feedback
We treat every complaint as an opportunity to do better. Trends, themes, and lessons learned are reviewed by Integra's directors on a regular basis, and changes to our processes are made where the feedback warrants it.