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Register your interest
- Fill in a short form or give us a call
- We’ll send you some information about the study via email
How it works
Learn about what you can expect to be involved in the trials process.
Jump down to our FAQs for trial participation related questions.
Understanding the journey: your guide to study participation
View our current studiesAt Genesis Research Services, we are passionate about providing our local community here in Newcastle with access to the latest medical innovations. Our team of investigative doctors includes a variety of medical specialists and GPs, allowing us to provide a broad spectrum of trial opportunities to our community.
At our established research centre, you will be cared for by a team of dedicated health professionals. You will see trained research coordinators at each study visit who will guide you through every step of your research journey and answer any questions you have. Our medical doctors take great interest in their research projects, ensuring you will be well cared for throughout your journey with us.
Participants are at the centre of everything we do here at Genesis.
Study visits
For more information about what happens at each study visit, click on the headings below, or read our clinical trials blog series.
Pre-screening
Your first contact with us usually begins with a pre-screening phone call. During this phone call, you will speak with one of our clinical trial coordinators, who will discuss the study with you and ask you a series of questions to determine if you may be eligible to participate in the trial.
If you are a suitable trial candidate, you will be booked in for a screening visit at our site. You will also be sent a copy of the participant information sheet, which will tell you all you need to know about the study and what your participation will involve.
Screening visit
During your first visit to our site, you will meet with the study doctor (investigator) and coordinator. You will discuss the study information and be encouraged to ask any questions before signing the informed consent form. Once consented, the investigator will assess your eligibility to join the trial. This usually involves reviewing your medical history and medications, physical examination, and completing health questionnaires. You may need to get blood tests and/or medical imaging elsewhere, which we will organise for you. If you satisfy all the eligibility criteria, you will be enrolled into the study.
Read more about the screening process here.
Baseline visit
Sometimes the screening and baseline visits are combined. During this visit, you will complete baseline assessments, which may include health questionnaires, clinical examinations, physical tests, and so on.
If the study is a randomised controlled trial, you will then be randomly assigned to either the study treatment group, or the control group (which may be a placebo). For new drug trials, you will be given the study treatment and may need to stay on site for a specified time to be monitored for possible side effects.
If the study involves a surgery or device implant, the coordinator will organise the procedure booking for you on another day. Some device trials involve a short trial of an external device before receiving an implant. Read more about medical device trials here.
Study visits
Depending on the trial, you may have multiple, regular follow-up visits to attend. During these visits, you will complete study assessments (often the same ones you did at the baseline visit, plus or minus others). You will need to report any changes in your medication and if you experienced any side effects. You may or may not receive additional doses of study treatment. For device trials, a clinical engineer from the device company will check your device and may reprogram it.
Final study visit
At the final visit, you will complete your last set of assessments and be exited from the study. If you have any ongoing side effects, the study doctor will provide ongoing care until they are resolved.
Read about what happens after a clinical trial here.
What is involved?
As a clinical trial participant at Genesis Research Services, your clinical trial journey with us may look something like the diagram below. The number of study visits will depend on the trial design and the type of treatment. If the trial involves a surgical procedure or device implant, these will be performed at our partnering day surgery centre or private hospital, which we will organise for you. Throughout every stage of your clinical trial journey, you will be looked after by a dedicated team of health professionals.
Frequently asked questions
About clinical trials
Who can participate in a clinical trial?
Anyone can apply to participate in a clinical trial, however, you will need to meet certain eligibility criteria (requirements) to qualify for study participation. This will be discussed with you over the phone before attending our site and during your first visit.
Where can I find clinical trials?
What are the benefits of participating in a clinical trial?
Clinical trials provide an opportunity to try a new treatment and contribute to important medical research that may lead to effective new treatments for others like you. You may or may not benefit from participating in a clinical trial. Possible benefits are discussed in this article. You can discuss the clinical trial with your GP, specialist, family, and friends before making a decision.
What are the risks of participating in a clinical trial?
All medical procedures and research studies come with potential risks. It is possible that you will experience side effects to the study treatment, or the treatment may not work for you, or you may receive a placebo. (Not all clinical trials use a placebo). The possible risks will be listed in the Participant Information Sheet that you receive before deciding to participate in a trial.
How will my safety be protected in a clinical trial?
Participant safety is of the utmost importance. Many measures are put in place to protect clinical trial participants.
Clinical trials involving new treatments must follow strict laws, regulations, and ethical guidelines. Before any clinical trial can start, the study must be approved by a human research ethics committee. The committee will include health professionals, researchers, lawyers, a minister of religion or elder, and lay members of the community. They will review the study and may request changes to ensure that the rights, safety, and wellbeing of the study participants will be protected. The committee will continue to monitor the study and require us to submit regular updates. They can terminate the trial if there are serious safety concerns or evidence of misconduct.
Application process
I applied for a clinical trial online. What happens next?
If we think you may be suitable for the trial based on the study requirements, we will call you to discuss the trial and ask more questions to see if you qualify for a screening visit. If you qualify, we will send you a copy of the Participant Information Sheet and Consent Form for you to read and book you in for a screening visit at our site.
Read more about the screening process here.
What happens at the screening visit?
At the screening visit, you will meet with the study doctor and coordinator to discuss whether the trial is right for you. You are encouraged to ask questions.
You will be asked to sign an informed consent form before providing any information, or completing any study assessments or tests required to determine if you are eligible to participate in the trial.
To determine if you are eligible to participate in the trial, you will be asked questions about your health and medical history. Screening may also involve completing health questionnaires, a physical examination, ECG, vital signs, blood tests, medical imaging, such as x-ray, MRI, or scans, or other assessments. You will be asked to sign an informed consent form before completing any study assessments or tests.
If you are eligible to join the trial, you will be booked in for a baseline visit. Read more about the screening process here.
I was told I wasn’t eligible to participate in the trial – why?
Every trial has a set of requirements for participation known as eligibility criteria. The criteria can be very strict. This is to ensure that you will not be exposed to any potential unnecessary risks, especially if the trial is likely to be of little to no benefit to you.
How do I register my interest for future clinical trials?
You can register your interest for future studies by filling out this form. Alternatively, you may call us on 02 4985 1860 or send an email to reception@genesisresearchservices.com.
Attending our study site
How do I get to Genesis Research Services?
We are located at 239-245 Denison Street, Broadmeadow, NSW (view on Google maps).
We have free, private parking for our participants on the right side of our building. Parking along the street is also free, however, please be aware that some areas have a 2-hour parking limit.
Our office is a short walk from Broadmeadow train station, and a 30-minute drive from Newcastle Airport.
What do I need to bring to my appointment?
Please bring a form of ID. It is a good idea to bring a copy of your medical history, including current and past medications and previous surgeries or procedures, to your first visit. Please also bring a copy of your banking details so that we may reimburse you for your travel and time as a study participant.
Are you affiliated with GenesisCare?
No, Genesis Research Services is an independent clinical research facility. We are not associated with GenesisCare.
Study participation
What does participation in a clinical trial involve?
This depends on the trial and will be explained in the Participant Information Sheet provided to you. If you have provided informed consent and met all the eligibility criteria at the screening visit, you are eligible to participate. You will then be booked in for a baseline visit. Baseline assessments and tests will be conducted before you receive the study treatment.
You will return to the site for follow-up visits, which may involve more health questionnaires, medical tests, and/or other assessments. The visit schedule will be outlined in your Participant Information Sheet.
For more information, read this article.
Who will I be seeing?
Our friendly staff are listed on our About Us You will be looked after by our front desk staff when you arrive. When you are ready to be seen, the trial coordinator will greet you and take you to one of our clinical rooms. The study doctor (also known as an Investigator) will meet you there.
For some studies, such as vaccine studies, the treatment may be given by a research nurse.
For a medical device trial, such as a spinal cord stimulator study, you will see a device technician (also known as a field clinical engineer, or a programmer). They will activate your device and change the settings to optimise the therapy for you.
Other healthcare professionals that you may see as part of a study include research assistants, psychologists, medical imaging staff, and hospital staff (for trials involving surgery or advanced procedures).
How long will my clinical trial participation last?
The length of a clinical trial will depend on the type of study, the treatment, and the trial phase (learn about phases here). Many of the trials that we conduct involve several months of participation. Some trials can last several years. Long trials often involve only one or two site visits per year after the first year or two.
The duration of a study and the number of study visits will be detailed in the study Participant Information Sheet.
Do I get paid to participate in a clinical trial?
You may be reimbursed for your time and travel expenses as a study participant. Any study procedures, equipment, and/or medical care related to your trial participation may be provided at no cost to you. Details will be provided in the study Participant Information Sheet.
Do I have to stop all other treatments, including medications, while participating?
You might need to stop certain medications before you can participate in a clinical trial, however, this should always be done under consultation with your doctor. Some trials require you to stay on a stable dose of your current medications during the study. Specific requirements will be outlined in the Participant Information Sheet and explained to you by the study doctor.
You must tell the study doctor or coordinator if there are any changes to your medications during your participation in the study.
Who do I contact if I have questions during the study?
Your study coordinator will be your main contact. To speak with them, please call 02 4985 1860.
If you need to talk to your study doctor between visits, we may be able to arrange a phone call. If you have any concerns, please call us on 02 4985 1860. We will notify the study doctor and book you in for an unscheduled visit if needed.
Can I stop participating in a clinical trial?
You are free to withdraw from a trial at any time. You do not need to give a reason, and your decision will not affect your ongoing medical care. For safety reasons, you may need to follow some instructions to stop the study treatment. If you have any ongoing problems or side effects, we will follow-up with you until they have been resolved or your condition is stable.
What happens after the clinical trial?
Once all participants have attended their last follow-up visit and all data has been collected, the data will be analysed, and a final study report will be written. The report will not have any information that can identify you. A summary of the results may be published in a medical journal. The whole process can take several months. You may or may not be notified of the trial results.
For more information about what happens after a trial, read this article.
Study treatment
What happens if I have side effects to the study treatment?
You should report any side effects or changes to your health, including minor or non-serious problems, to your study doctor or coordinator. Please call us on 02 4985 1860 if you have any concerns and need to see the study doctor before your next study visit.
If you are experiencing serious side effects or changes to your health, please call us so that we may book you in for a visit as soon as possible.
During the study, you will be given a contact card with an afterhours mobile phone number. In case of an emergency, please call this number to talk with a study coordinator. For any non-urgent matters, please call our office number on 02 4985 1860 during work hours.
Can I stop the study treatment?
You are free to withdraw from the trial at any time, however, you should talk to the study doctor before stopping a study treatment. They will advise you on how to safely stop the treatment.
For studies involving implanted medical devices, we can arrange for you to have the device surgically removed (explanted).
Can I continue the study treatment when the trial is finished?
Whether or not you can continue taking a study drug or keep a medical device after a trial will be explained in the Participant Information Sheet provided to you. If the treatment has not yet been approved for use in Australia, you might not be able to access it after the trial. However, your doctor may be able to apply for special access to prescribe unapproved goods. You should discuss your options with your study doctor.
What is a placebo?
A placebo is a treatment that has no active properties. An example is a sugar pill that looks the same as the study drug. Not all clinical trials involve a placebo. Comparing the study treatment to a placebo allows researchers to see if the study treatment has any real effects. Participants are usually not told if they will receive placebo or study treatment.