Plain-language answers about what taking part in a clinical trial involves, reviewed by our clinic team. Your study's consent form is always the final word on specifics.
What is a clinical trial?
A clinical trial is a research study involving volunteers. It may test a medication, treatment, medical device, procedure, diagnostic test, or another way of managing a health condition. Not every clinical trial involves medication, and not every clinical trial uses a placebo. The exact purpose of any study is explained to you before you decide whether to participate.
Is research at the clinic approved before it starts?
Yes. Before any study begins, it is reviewed and approved by an independent research ethics board. Studies involving medications also follow Health Canada requirements.
Why was I contacted about a study?
You may have been contacted because you have, or may have, the health condition being studied. Being contacted does not mean you automatically qualify. The study team will ask some questions and may perform tests to determine whether the study is appropriate and safe for you.
Does showing interest mean I have agreed to participate?
No. Speaking with the research team, completing a telephone questionnaire, or attending an information appointment does not mean you have joined. You only participate after the study has been explained, your questions have been answered, and you have voluntarily provided written consent.
Do I have to participate?
No. Participation is completely voluntary. You may say no, take time to think about it, or speak with your family or healthcare provider before deciding.
Will saying no affect my care at the clinic?
No. Your decision about research never affects the regular medical care you are entitled to receive.
Do I need to be an existing patient of the clinic to join a study?
No. You do not have to be an existing patient of the clinic to take part in a study.
How will you determine whether I qualify?
Most studies begin with screening. Depending on the study, this may include questions about your symptoms and medical history, a review of your medications, a physical examination, blood or urine testing, vital signs, pregnancy testing when applicable, questionnaires, and a review of relevant medical records. The exact screening steps for each study are explained before you consent.
Why might someone not qualify?
Every study has specific eligibility requirements. These may relate to age, diagnosis, symptoms, medical history, medications, laboratory results, pregnancy, other health conditions, or previous treatments. These requirements protect participants and keep study results scientifically reliable. Not qualifying does not mean anything is wrong with you or that you did something incorrectly.
Will I find out why I did not qualify?
The study team will normally share as much as it is permitted to share. Sometimes the team may only be able to explain that one or more study requirements were not met.
Is screening the same as joining the study?
No. Screening determines whether you may be eligible. You may complete screening and still not qualify, or decide not to participate.
What is informed consent?
Informed consent is the process of explaining the study so you can make an informed decision. The study team reviews a consent form with you covering why the study is being conducted, what you will be asked to do, how long it lasts, possible risks and benefits, other treatment choices, costs and compensation, how your information and samples may be used, who to contact, and your right to leave. You should not sign until your questions have been answered and you feel comfortable deciding.
Can I take the consent form home before deciding?
Yes. You may discuss the study with your family, family doctor, pharmacist, specialist, or anyone else you trust.
Will I receive a copy of the consent form?
Yes. You receive a copy of the signed consent form for your records.
Can the study information change after I join?
Yes, and this does happen from time to time in real studies. Researchers may learn new information during a study, and when it could affect your safety or your willingness to continue, the research team explains it to you and may ask you to sign an updated consent form. The re-consent process exists exactly for that situation.
How long do studies last?
It varies by study, from a few weeks to a few years. The exact length, number of visits, and follow-up period for a specific study are explained before you consent.
Where do appointments take place?
Study visits take place at our Mississauga clinic. Some studies allow certain appointments by telephone or video.
What happens during study visits?
Depending on the visit, the study team may ask about your health and symptoms, review medication use, ask about side effects, measure vital signs, perform a physical examination, collect blood, urine or other samples, complete questionnaires with you, provide or collect study medication, or review your diary or app. You receive a schedule explaining what to expect at each visit.
Will I need to keep a diary or use an app?
Some studies ask participants to record information such as symptoms or medication use in a paper diary, on a website, or in a mobile app. If your study includes one, the team shows you exactly what to record and how often.
What happens if I miss an appointment?
Contact the study team as soon as possible. They will determine whether the visit can be rescheduled and whether anything must happen within a specific time window. Missing one appointment does not automatically remove you from a study, but repeated missed visits may make it difficult to continue.
Will I receive the study treatment?
It depends on how the study is designed. Some studies give every participant the treatment, while others compare groups. The possible groups, and your chance of being in each one, are explained before you consent.
What is randomization?
Randomization means a computer assigns participants to a study group by chance, similar to drawing names from a hat. It helps researchers compare groups fairly. Neither you nor the clinic chooses the assigned group.
Is there a placebo?
Some studies include one and some do not. A placebo looks like the study treatment but does not contain the active study medication. Whether your study uses a placebo, and your chance of receiving it, is always explained clearly before you consent.
Will I know which treatment I am receiving?
It depends on the study design. In open-label studies, you know. In blinded studies, you, and sometimes the study staff, do not know during the study, which reduces bias. Your treatment assignment can always be accessed when medically necessary.
Can I choose which group I enter?
No. When a study uses randomization, the group is selected by chance.
Can I keep taking my regular medications?
Never stop or change any medication on your own. The research team reviews all prescription medications, over-the-counter products, vitamins and supplements with you at screening. Some studies restrict certain medications; any restriction is explained before you decide, along with what you may use if your symptoms worsen.
Are there risks?
All clinical trials have possible risks or inconveniences. These may come from the study treatment, medical procedures, changes to medications, blood collection, time commitments, travel, or questionnaires. The known and reasonably foreseeable risks of a specific study are explained in its consent form.
What side effects could happen?
It depends entirely on the study. Known possible side effects are listed in the consent form and reviewed with you before you join. There may also be side effects that are uncommon or not yet known, which is why you should report any new symptom or change in your health promptly.
What should I do if I have a side effect?
Contact the study team. The study doctor may ask questions, arrange an assessment, order testing, pause or adjust the study treatment, recommend other care, or remove you from the study if that is safest. For a medical emergency, call 911 or go to the nearest emergency department, and tell them you are participating in a clinical trial.
Is someone monitoring my safety?
Yes. The study doctor and research staff monitor participants throughout the study. Depending on the study, safety information may also be reviewed by the sponsor, independent safety reviewers, a research ethics board, and regulatory authorities such as Health Canada.
Can the clinic remove me from a study?
Yes, when continuing may not be safe, when you no longer meet study requirements, when you need a treatment the study does not allow, or when the study itself is stopped. The team explains any follow-up care you need.
Are there pregnancy-related requirements?
Many studies have them, because the effects of a study treatment during pregnancy may not be known. Requirements can include pregnancy testing, using an approved form of contraception, and reporting a pregnancy immediately. Any requirements that apply to you are explained before you consent.
Will the study improve my condition?
There is no guarantee of personal benefit. Your condition may improve, stay the same, or worsen. What is learned may help researchers better understand the condition or develop treatments for future patients.
What are my choices if I do not participate?
They may include continuing your current treatment, receiving another approved treatment, discussing other clinical trials, choosing no treatment, or receiving other care recommended by your healthcare provider. Your study doctor or regular provider can discuss these choices with you.
Does participating cost me anything?
No. Study-related visits, testing and study medication are provided at no charge. You remain responsible for regular medical care you would have received anyway. Any possible costs are clearly explained in the consent form.
Will I be paid or reimbursed?
Many studies compensate participants for their time or reimburse travel and parking. Amounts and schedules are study-specific and are explained before you decide. Payment is never based on whether the treatment works. Your study team will discuss this information with you.
Will my information be kept private?
The research team takes steps to protect your information, and study records commonly use a participant number rather than your name. Complete confidentiality cannot be guaranteed, and the consent form explains exactly who may access identifiable records and the safeguards used. Research reports and publications do not identify you unless you specifically consent to being identified.
Who may see my study records?
Authorized individuals may include the study doctor and research staff, the study sponsor and its representatives, research monitors or auditors, the research ethics board, Health Canada or other regulatory authorities, and laboratories or service providers involved in the study. They review records to confirm the study is being conducted properly and that the information collected is accurate.
Will study information go into my regular medical record?
Some information related to your care may be added to your clinic record. The consent form for your study spells out exactly what is recorded.
Will you tell my family doctor I am participating?
We recommend that your regular healthcare providers know about the study whenever it could affect your care or medications. Whether and how we notify them is explained during the consent discussion.
What happens to my blood, urine or other samples?
It depends on the study. The consent form explains what is collected, why it is needed, how long samples are stored and where, whether they may be used for future research, whether genetic testing is performed, and whether samples may be sent outside Canada. Coded samples may still be linkable to you by someone who holds the code; once samples are anonymized, combined with other results, or used in testing, removing them may no longer be possible.
Will I receive my test results?
You receive results that are part of your medical care or that the study is required to provide. Some research-only results are not returned because they are experimental, are not considered clinically meaningful, or are produced after information has been coded or anonymized.
Can I change my mind after joining?
Yes, at any time. Tell the study team so they can explain how to stop safely and whether a final safety visit is recommended. Leaving a study never removes your right to regular medical care.
Do I need to give a reason for leaving?
No. You do not have to provide a reason, although sharing one may help the team understand your concerns.
What happens to information already collected if I leave?
The consent form explains this. Information that has already been used, analyzed, submitted for safety reporting, combined with other participants' information, or anonymized may not be removable. You may be asked whether the team can continue collecting limited safety information after you stop treatment.
Can I stop the treatment but stay in follow-up?
Some studies allow it, with safety visits, questionnaires, or medical-record follow-up continuing. If that option exists in your study, the team explains it.
What happens when my participation ends?
The team may complete a final examination, collect final samples, review your symptoms, collect unused study medication, explain any required follow-up, discuss your ongoing care, and tell you how to receive study results.
Can I keep using the study treatment afterward?
It depends on the study, whether the treatment becomes approved, and the sponsor's arrangements. Continued access is never guaranteed, and the study doctor will discuss what is medically appropriate for you.
Will I receive the overall study results?
It depends on the type of study. Some studies share a plain-language summary of overall results when they become available; others do not, or take longer, because information from all participants must be collected, checked and analyzed. Your study team will tell you what to expect for your study.
Who do I ask about a study?
Call 437-317-1991 or email researchinfo@allergycentre.ca. Speaking with us does not commit you to joining anything.
Who do I contact about a medical problem during a study?
Participants receive direct study-team contact numbers at enrollment; use those. For a medical emergency, call 911 or go to the nearest emergency department and tell them you are participating in a clinical trial.
Who can I talk to about my rights as a research participant?
You may contact the independent research ethics board listed in your consent form, even if you do not want to speak with the study doctor or clinic first.
Call 437-317-1991 or email researchinfo@allergycentre.ca and the research team will walk you through it.