Glossary
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A clinical trial is a multi-step process during which a research team supports and keeps the participants informed.
What Is a Research Team?
The research team includes the following members. They are responsible for responding to your questions, doubts or concerns, providing support for any problems and monitoring your safety:
- A designated healthcare professional (principal investigator) responsible for the clinical trial within their health institution. Although investigators are usually physicians, dentists can also conduct clinical trials for dental products.
- Healthcare professionals (pharmacy staff, nurses, other clinical specialists...) who perform certain procedures specific to the clinical trial.
- Clinical research coordinators who oversee the daily steps of the clinical trial and may be present during study visits.
At any time before, during or even after the clinical trial, you may contact a team member directly, for any reason, without risk of harm. This is one of your rights.
Steps of a Clinical Trial
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Before the clinical trial
1
Presence or absence of diagnosis
- You may choose to participate in a clinical trial at any time, after receiving a diagnosis or even without a diagnosis.
2
Identification and referral
- We recommend you speak with your medical team before beginning the clinical trial identification process.
- You can identify clinical trials:
- On your own, using Quebec’s clinical trial Database
- Using Clinical Trials Quebec’s Personalized Support Service
3
Informed consent
- Before you participate in a clinical trial, the research team will explain the study to you and give you a document (informed consent form) with information about the study. You will have time to read it and discuss it with others if you wish. The research team will be available to answer any questions you may have.
- Once you feel you have enough information to make an informed decision, you may choose to consent or refuse to participate in the clinical trial by signing an informed consent form.
During the clinical trial
At any time, you are free to cease to participate in the clinical trial without having to provide a reason. This is one of your rights. You will not be negatively affected by your withdrawal from the trial.
4
Screening visit
- If you agree to participate in a clinical trial, a screening visit will be scheduled. During this visit, the research team will review the information and consent form with you, answer any questions you may still have and ask you to sign the form.
- Then, tests will be conducted to ensure that you meet all the eligibility criteria. These may include laboratory tests (blood, urine), imaging tests (X-ray, scan) and physical tests. If the results of these tests meet the eligibility criteria, you may be recruited into the clinical trial.
5
Study visits
- Once your participation in the clinical trial is confirmed, there will be several study visits. The purpose of these visits is, among other things, to give you or administer the study treatment, monitor your health, look for side effects and collect the data required by the trial.
- The number, frequency and nature of these visits, as well as the procedures that will be carried out, vary from one trial to another.
- Depending on the clinical trial, some visits may be at the site (hospital, clinic), at home, by videoconference or by telephone.
Between visits, you will usually have certain ongoing responsibilities, including, for example: taking the prescribed drugs at home, keeping a diary of symptoms or side effects experienced, following the instructions provided by the research team, etc. The members of the research team are available when needed to answer your questions and concerns, and to support you throughout your participation in the clinical trial.
6
End of treatment visit and/or last study visit
- The last study visit may be the visit where you stop receiving treatment, or it may be the last in a series of follow-up visits to monitor your health.
- Even after the clinical trial is complete, you can continue to communicate with the research team.
After the clinical trial
7
Results disclosure
- Once the clinical trial is complete and the research team is authorized to disclose information, you and the other participants may ask for the results of the clinical trial (usually after several months or years).
8
Scientific publication
- Clinical trial results are made available in publications reviewed by scientists in the same field of research (peer-reviewed publications).
- Research data may be published or discussed in the scientific community, but the individuals involved will not be identified.
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