It is beneficial to learn as much about the study as you can before enrolling. The Center for Information & Study on Clinical Research Participation (CISCRP) provides a comprehensive list of questions for patients, parents, potential study volunteers, and other family members or friends to ask the research staff prior to joining a clinical trial.
Before joining the clinical trial, you will speak with the study team to learn more about the trial in which you are interested. This will provide you with a thorough understanding of the study, including the time frame, and any measurements or procedures that will be used throughout.
Once you fully understand the components of the study, you or your loved one can agree to participate by signing the informed consent form. This outlines your rights and responsibilities and acknowledges that the study has been clearly explained to you. Signing a consent form is not a contract—as a participant, you may withdraw from the study at any time.
During this step, the study site team reviews your medical history and conducts a physical exam to determine if you qualify to participate. Clinical studies each have different standards or guidelines that outline who can participate called “inclusion criteria”. Studies also have factors that prohibit certain people from participating called “exclusion criteria”. The study team will inform you if you qualify for the study.
Once you qualify for the study, you are then able to be enrolled and can begin treatment. From here, you will meet with the research team leading the study to gain an understanding of next steps, including what you will need to do and how often you will meet with the team. Typically, after enrolling in a clinical study, participants will also continue to meet with their usual healthcare providers.
The type of study a participant is in will determine how often they will meet with the study team and what is required at each visit. These visits may involve performing physical exams, answering questionnaires, or carrying out other procedures that researchers use to gather data.
When the clinical trial is over, you may still stay in touch with the study team. After participation in the trial has ended, the participant and their healthcare provider should work together to determine the next steps for care. Some clinical trials are designed to provide access to the study treatment after the trial is over, while others are not.
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