Coeliac Disease Research Study

A volunteer’s eligibility will be assessed at multiple stages – first, our recruitment team at Canopy Clinical will conduct a pre-screening phone call, where we will outline the trial and discuss your medical history, current medications, and general interest in taking part.  

Should it appear that you may be eligible, we will invite you to visit our clinic closest to you for a screening visit, where you will meet with our medical team for further discussion and evaluation of your eligibility to participate in the trial.  

You will also go through the process of Informed Consent, where you will review the Participant Information and Consent Form (PICF) for the trial with the help of a doctor to answer any questions you may have. All potential risks and benefits, as well as your rights and responsibilities during the trial are detailed in this document to help you make an informed decision on participation prior to enrolment. 

The Australia Charter of Healthcare Rights outlines the rights of all people in all places where healthcare is provided. Canopy Clinical acknowledges and abides by these healthcare rights at all clinical research sites. You can download a copy of your healthcare rights via this link.

Once enrolled, you will then complete a series of follow-up visits to our clinic – the number and duration of these will vary depending on the trial. During these visits, you may undergo further medical assessments, further dosing with the investigational treatment, or complete questionnaires. A description of all required activities will be listed in the Participant Informed Consent form provided before you begin the trial. 

Participant safety and wellbeing is paramount at Canopy Clinical – prior to enrolment in any trial, you will be guided through the Informed Consent process, ensuring that you have a clear and thorough understanding of potential risks, restrictions and activities involved in the trial to help you make an informed decision.  

Before a trial begins recruitment, it must be approved by an independent Human Research Ethics Committee (HREC), which ensures the study is scientifically valid and prioritizes participant well-being. HRECs in Australia abide by the National Statement on Ethical Conduct in Human Research, which is referenced in Therapeutic Goods Regulations. 

Throughout the trial, participants are closely monitored by healthcare professionals, and safety data is regularly reviewed.  

Often, treatments and medical procedures involved in clinical trials have the potential to cause side effects. The Participant Information and Consent Form provided to you prior to enrolment in a trial will contain a full list of known side effects based on previous studies and similar existing treatments.  

Our medical team will closely monitor you throughout your participation for any side effects. 

Once a clinical trial is complete, the results of each participant group are analyzed, summarized and published as a report on an online registry such as clinicaltrials.gov, or as a paper in a scientific journal. These results are completely de-identified. This process can take anywhere between several months to years, depending on the amount of data collected and the complexity of the trial.  

You can request the report of the whole participant group from your trial doctor once they are published. However, it is unlikely that your individual report will be provided – you can instead request the results of your individual medical tests, such as blood work, electrocardiograms and imaging conducted during the trial. 

The Participant Information and Consent Form outlines what information will be shared and what happens with your results.   

When sharing your data with authorized agencies, your data is ‘de-identified’ and replaced with a participant ID or code – meaning that your personal details are not disclosed. This ensures that your information remains confidential and cannot be traced back to you. 

Your personal contact details will only ever be used for the purpose of research at Canopy Clinical and will not be shared with any third parties without your explicit permission, except when required by law. 

Depending on the trial, participants may receive reimbursement. This could be in the form of reimbursement for expenses incurred to attend visits, such as travel costs or parking fees. It could also be a stipend payment for your time and effort invested into the study. Sometimes, you may receive a combination of both.  

Our dedicated recruitment team at Canopy Clinical will be able to provide reimbursement information for each trial during your pre-screening call.

A placebo is a substance that resembles the drug being tested in the trial, but does not contain any active ingredients that will produce a therapeutic effect. This may be in the form of a sugar pill or an injection containing saline solution, for example. 

Investigational treatments in clinical trials are often compared to a placebo group as a way of accurately measuring their effectiveness. Usually, the participants will not know which treatment they have been assigned to receive.

Participants will always be informed on whether a placebo group is being used in trial or not, as well as their chances of being assigned to the placebo group during the informed consent process. Depending on the participant, a trial involving a placebo may not be acceptable – always discuss with your doctor what may be best for you.