For Participants > What to Expect
For Participants
What to Expect
Thinking about joining a clinical trial? Here's everything you need to know about what happens, what's involved, and how we look after you every step of the way.
Considering a clinical trial? You're in safe hands.
Taking part in a clinical trial is a meaningful commitment; one that contributes to medical research and helps develop new treatments. At Clinical Trials Institute (CTI), we understand that deciding to participate can feel like a big step. That's why we're here to walk you through exactly what's involved, answer every question, and make sure you feel completely comfortable before, during, and after any trial.
Every person who joins a trial at CTI plays a vital role in advancing medicine. Whether you're motivated by access to new treatments, the chance to help others, or simply curiosity about contributing to research; we're grateful you're here.
What is a Clinical Trial?
A clinical trial is a carefully designed research study that tests new medical treatments, medications, devices, or ways of delivering care. Trials help doctors and researchers learn whether new approaches are safe and effective before they become widely available.
Every medication you've ever taken, from everyday pain relievers to life-saving treatments- only exists because people just like you agreed to take part in a clinical trial. Participants are the reason medical progress happens.
The phases of a Clinical Trial
Clinical trials are conducted in stages, known as phases, to answer different research questions as a new treatment is developed. At CTI, we typically work across Phase 1b through Phase 4 trials.
- Phase 1 - Tests a new treatment in a small number of people to understand how it works in the body and identify any side effects.
- Phase 2 - Looks at how well the treatment works and continues to monitor safety in a larger group of participants.
- Phase 3 - Compares the new treatment to current standard treatments in a larger population to confirm effectiveness.
- Phase 4 - Takes place after a treatment has been approved, collecting longer-term information about safety and benefits.
The specific phase of any trial you're considering will be clearly explained to you in plain language before you decide whether to take part.
Your journey with us
From the moment you first register your interest to the final follow-up, here's what the process looks like:
1
Register your interest
The first step is easy: fill in our short online form or give us a call. We'll ask a few basic questions about your health and contact details so we can match you with trials that suit you. There's no commitment at this stage. Your information stays confidential and you'll only hear from us when a suitable trial is available.
2
Initial phone call
A member of our research team will give you a call to discuss the trial in detail. We'll talk you through the study, answer any questions you have, and go over some basic eligibility criteria. This call is also your chance to ask anything: About the trial, about CTI, or about the process. There's no pressure, and you can change your mind at any time.
3
Screening Visit & Informed Consent
If you're interested in moving forward, we'll invite you into our Torquay clinic for a screening visit with one of our trial nurses. Before anything else happens, we'll walk you through the informed consent process: A detailed conversation where we explain the purpose of the study, exactly what's involved, any potential risks and benefits, and your rights as a participant. You'll have time to read everything carefully, take the forms home if you'd like, and ask as many questions as you need before making your decision.
A note on Informed Consent
Informed consent isn't just a signature; it's an ongoing conversation. You can withdraw consent at any point during the trial, without having to give a reason, and without any impact on your regular medical care.
4
Participation in the Trial
Once you've given consent and been confirmed as eligible, you'll begin the trial. What this looks like depends on the study; it may involve clinic visits, health questionnaires, physical examinations, blood tests, or taking study medication.
Some trials are straightforward with just a few appointments, while others are more involved. Whatever the study, you'll always know exactly what to expect at each visit.
Throughout the trial, you'll be closely monitored by our team of experienced doctors and research nurses. Your safety is our highest priority, and we're available to you at every step.
5
Follow-up & completion
Once the trial ends, you'll attend a follow-up visit so we can make sure you're doing well. Any agreed reimbursement for your time and travel is processed during or after the study, and with your permission we can share a summary of your participation with your regular GP to ensure your ongoing care stays coordinated.
Your rights as a Participant
Participation is always Voluntary
You're free to say no at any time. You can also withdraw from a trial at any point, for any reason, without having to explain yourself, and without it affecting the medical care you receive from your regular doctor or anywhere else.
Your privacy is protected
All personal and medical information is handled confidentially and stored securely. During the trial, your data is coded so it can't be linked back to you, and only authorised research staff (and relevant regulatory bodies where required) have access.
You're always well cared for
Throughout your trial, you're supported by our dedicated team of specialist trial nurses, the compassionate backbone of every study we run. Trained specifically in clinical research and backed by decades of combined experience, they're there for every visit, every question, and every concern. With your permission, we'll also keep your regular GP in the loop, so your ongoing care stays coordinated.
You're informed every step of the way
Everything is explained in plain language, in advance. No surprises, and no pressure to decide quickly. If something doesn't make sense, we'll explain it again. If you need time, we'll give you time.
How we protect your safety
Every clinical trial carries some level of risk, it would be dishonest to say otherwise. But every trial at CTI is designed, reviewed, and monitored with your safety as the absolute top priority. Here's how we make that happen:
Independent Ethics Approval
Every trial at CTI is reviewed and approved by an independent Human Research Ethics Committee (HREC) before any participant is enrolled. These committees include medical professionals, scientists, and community members, all focused on protecting your rights and wellbeing.
ICH-GCP accredited team
Our team is accredited to International Conference on Harmonisation - Good Clinical Practice standards. This is the global gold standard for clinical research, covering everything from how data is collected to how participants are cared for.
Continuous monitoring by specialist trial nurses
Throughout your trial, our specialist trial nurses monitor your health closely at every visit and are always available to answer questions or address concerns between appointments.
A clear point of contact, always
You'll have a direct line to your trial coordinator throughout the study.
Robust safety procedures
Every trial has documented procedures for managing unexpected events. If something unusual happens, we act quickly, escalate appropriately, and keep you informed every step of the way.
Australian Regulatory Standards
All trials comply with Australian regulatory frameworks, including oversight from the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC).
While you're with us
Most trial visits take place at our main Torquay site, which is designed to be as comfortable and welcoming as possible. Here's what you can expect:
Care from specialist trial nurses
Our nurses are the compassionate backbone of every trial. Trained specifically in clinical research and with decades of combined experience, they're there at every visit to answer questions, monitor your wellbeing, and make sure you feel supported from start to finish.
Designed around your schedule
Clinical trials shouldn't disrupt your life. We offer extended hours by arrangement, telehealth visits where suitable, and flexible appointment scheduling. Participating fits into your week, not the other way around.
Reimbursement for your time
Various trials offer reimbursement for your time, travel, and out-of-pocket expenses. The amount varies between studies and will always be clearly explained before you decide to take part.