What to expect in a clinical trial

[spoiler title="Informed Consent Forms:" open="1" style="2"]

In order to participate in a clinical research study/trial, all participants will have to first sign an Informed Consent Form - ICF. This document clearly explains the project, your role in the research study, any risks that may exist, and the length of the study and so on. We encourage all participants to take as much time as they need to review the information given. You can take the ICF home and/or to their family doctor to discuss & make an informed decision to participate. You may contact the study coordinator or staff anytime in case you may have any further questions or concerns regarding the study or your participation.

[/spoiler] [spoiler title="First Study Visit:" open="0" style="2"]

At the first study visit, the Informed Consent Form is signed (if not previously signed) and we collect baseline medical data. For example, we will ask about medical and surgical history, smoking history and your overall health. We also ask about any current or recent medications, and will check blood pressure, pulse, height and weight before the study doctor performs a brief physical examination. Blood work, lung function testing, a cardiogram or other medical diagnostic tests may also be performed at this time. All these assessments are performed to ensure your safety as well as these data serves as your baseline profile.

[/spoiler] [spoiler title="Follow Up Visits:" open="0" style="2"]

Once this initial visit is over, you return regularly for brief, protocol defined follow up study visits [visit length & frequency varies from study to study]. At each appointment we ask how you have been since your last visit, whether there have been any changes to your medications and whether you have seen any other doctors or required a visit to hospital. We check your study diary (a record of your medications and symptoms), and collect and dispense medication. Other procedures may also be performed, depending on the particular requirements of the study protocol. Staff will advise you as to what to expect during your next scheduled visit.

[/spoiler] [spoiler title="Final Study Visit:" open="0" style="2"]

A final study visit will be necessary where all study-related items such as medications and diaries are collected. We will complete any final study assessments and, if required, the study physician may perform another brief physical examination. This visit is more to assess your safety again at the end of the study.

[/spoiler] [spoiler title="Support and Feedback:" open="0" style="2"] Throughout these visits, we actively encourage participants to ask questions or voice concerns. We also provide participants with the office telephone number for the principle research coordinator, as well as a 24-hour emergency telephone number.
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