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What is a
Clinical Trial?
What is a Clinical Trial?
To get FDA approval, the company that makes the medication or device is required to conduct clinical research studies.
The companies ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members.
After clinical research studies are complete, the pharmaceutical company submits the study information to the FDA. The FDA reviews this information and decides if the investigational medication or device can become available to the public.
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How do I qualify?
Every clinical trial has eligibility requirements related to your age, health, and reproductive status. You must meet all of the eligibility requirements to take part in a trial.
If you see a trial that interests you and you meet the stated eligibility requirements, you can apply online to take part. After you’ve applied, a trial staff member will contact you to invite you to a meet with doctors and staff members at our clinic, to discuss the trial and be assessed against the eligibility requirements.
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What to expect
During your trial clinic visits, trial doctors and staff members will evaluate your health and response to any medication you’ve been given and answer any questions you may have. Some of the tests and assessments they use may include:
- Reviews of your medical history
- Physical exams
- Vital signs measurements
- Blood and urine sample collections
- Questions about how you are feeling
- Reviews of any medications you are taking
- Reviews of any side effects you may experience
Study doctors and staff members will go over all tests and assessments. You will be encouraged to ask questions about anything you don’t understand.
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Refer a Friend
When you select the Share This button, you will be directed to enter your friend or relative’s contact information and the study number. Your friend or relative will receive only one notification about the study.
If your friend or relative participates and is dosed in a clinical trial with us, we may pay you $200-$500, as a way of showing our appreciation for your efforts.
*Compensation only for registered volunteers who have completed a study.
FAQs
If I qualify for a study, do I have to participate?
What ID should I bring to my screening appointment?
You are required to bring in a government issue identification, for example a passport, driver’s licence, or State Identification Card.
Can I come and screen for two different studies?
How long does a screening appointment last?
Typically, screening can take around 2-4hours. Screening consists of a consenting, following consent, screening procedures will commence, the time for these is very dependent on the specific screening procedures for the study.
Can you transfer my screening results from one study to another study, to save me doing two screening visits?
You must attend an individual screening for each study. Each study has varying assessments and blood/urine tests that are performed.
Can I bring my child to my screening visit?
Do I get paid for screening and doing the clinical trial?
You will be compensated for your time and inconvenience if you signed the study consent, all payments are outlined in the Informed consent document, the only exception is if you test positive for drugs of abuse (recreational drugs), alcohol, nicotine (if applicable) and/or double enrolled in another study at another site.
If I pass screening and am eligible, will I get dosed on a study?
What does a backup/alternate volunteer mean?
Can my family or friends visit me when I’m staying in your clinical unit for overnight stays?
If I join a study, do I have to complete the study?
No, you are free to leave a study at any time and for any reason. However, if you do leave a study, the study doctor or study staff may ask you some follow-up questions, and you will not be allowed to re-join the study.
What if I decide I want to stop or withdraw from a clinical trial after I’ve signed an Informed Consent Document?
Volunteers are free to withdraw from a study at any time. This will not affect the standard of care you recieve, or your legal rights.
How many follow-up visits are required?
It depends on the study. Some studies may require more follow-up visits than others. The study doctor or the study staff will go over how many follow-up visits you may need to make.
Will you be paid for participating in a study?
It depends. Each study is different. Contact our clinic to learn more about study participation. Additionally, all study medication, tests, and assessments will be provided to you at no cost.
If I refer a friend for screening, will I get a referral fee?
A referral fee is available for specific populations and study designs. Make sure your referral provides your name when scheduling the appointment.
Can I get study medication outside of clinical research studies?
No, only study volunteers are eligible to receive study medication. Clinical research study medications are not available to the public.
Should I talk with my family, friends, and personal doctor before participating in a clinical research study?
- Reviews of any medications you are taking.
- Reviews of any side effects you may experience.
What type of room will I be staying in?
Rooms are up to 2-4 bed occupancy. These are single hospital type beds with TV remote controls and a call light. There are bathrooms in each room as well as additional restrooms on the unit.
Do I need to provide my own toiletries and towel?
Is there a washing machine available to use?
A washer and dryer are available at the unit. The laundry schedule can be provided to you at the time of admission. Note the laundry service is not suitable for dry clean only’ items.
What meals are served at the unit?
We do provide Vegetarian options, but this is study dependent. Some studies require you to consume high fat meals. Please note that no outside food is allowed, this includes ordering food while staying on our unit.
Can I bring some snacks and food items with me?
Can I have packages and mail items delivered to the unit?
Where do I park for Visits?
Will I be paid in instalments or all at once?
How will I be paid for the clinical trial and when do I receive my payment?
Are there any side effects?
How long do you keep my data and is it confidential?
How long does it take for my blood results to be available?
I was a backup/alternate on the last study so does that mean that I won’t be a backup/alternate next time?
What are recreational drugs?
What is WONCBP?
How frequently can I take participate in a clinical trial?
What is meant by Wash-out/ Half-life of a study?
What happens if I’m not able to make an outpatient visit due to a planned holiday/vacation?
What is a chronic disease?
What is a long-term illness?
What do you mean by serious injury or illness?
Is there a smoking room within the unit?
I gave up smoking a recently, can I take part in your trial asking for non-smokers?
I have a family member who works for your company, can they come to visit me?
Are face masks required?
Find out what some of our volunteers have to say about us.
Take our virtual tour
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Do you have more questions?
- Why not give us a call where our team will be happy to answer your questions?
Do you have more questions?
Why not give us a call where our team will be happy to answer your questions?