Frequently Asked Questions:

	Question	Answer
1	What is a clinical research study?	Clinical research studies typically test the safety and effects of medications and treatments on volunteers. They are an important stage of the development of new drugs and for new applications of existing drugs.
2	Will I get paid for participating? How much?	Some studies offer financial compensation to the participants, while others provide reimbursement for time and travel and treatment by a specialist. The amount of compensation depends on the number of visits, blood tests, overnight visits and the complexity of the study.
3	What happens if I have a reaction to the drug?	At Kendle Early Stage - Toronto, your safety is paramount. However, any time a medication is used, side effects are possible. If a side effect does occur, physicians and registered nurses are always on site. Common side effects will be discussed during the first visit as part of the informed consent process.
4	Who can participate in a clinical study?	All clinical studies have predetermined inclusion criteria as well as exclusion criteria that determine your eligibility for study participation. These factors enable the researchers to identify appropriate participants and to ensure safety throughout the study. People who have a specific condition being studied in a study can be eligible for a study. In addition, healthy volunteers also may take part in studies to test the drug's effects and safety. Each study will have specific requirements that vary depending on the study objectives. As an example, medical condition, age and sex may be part of those requirements. Each volunteer's medical history will be reviewed in light of the study requirements to determine if the volunteer is eligible. The Health Products and Food Branch (HPFB) of Health Canada has instituted very specific requirements for studies and who may participate, and Kendle Early Stage - Toronto stringently adheres to these requirements.
5	What are the accommodations, food and entertainment like?	We have modern facilities that have been specifically designed for clinical studies that involve overnight stays. Our comfortable facilities feature bathrooms with showers, lockers, lounges with digital cable TV and kitchens with refrigerators that are fully-stocked with fruit, drinks and bottled water. Meals and snacks are provided depending on the study type and duration. Study participants are also encouraged to bring their own work, music or reading materials to make their stay more comfortable.
6	Are the studies confidential?	Your privacy is important to us. Personal information will not be shared with any external party without your informed consent. Kendle Early Stage - Toronto has a very stringent Privacy Policy which can be supplied to you at the screening interview or downloaded from this site.
7	Can I leave a clinical study after it has begun?	Yes, you can leave a clinical study at any time.
8	Do you have weekend studies?	Yes, we now have more options for weekend studies, and more weekday studies too. The specific schedule of your study will be discussed with you during the screening process.
9	How many times do you take blood?	Most studies have blood tests at the beginning and end of the study for safety reasons. Other studies, for example, may require periodic blood draws to see how long it takes for a medication to leave the body. The amount of blood taken will vary from study to study, but will be well within established safety guidelines.
10	What is informed consent?	Informed consent gives volunteers information about a clinical research study so that they may make an informed decision to participate in a study. The informed consent process ensures that volunteers can get answers to questions about the study and be comfortable about the nature of the study in general. The study coordinator/nurse and physicians are responsible for making sure that each volunteer provides informed consent before participating in a study.
11	Do I have to stay overnight?	For healthy volunteer studies, there are overnight visits. For treatment studies, it is unlikely that you will have to stay overnight.
12	What to bring for overnight studies?	We provide food and linen. You should bring clothing & personal toiletries.
13	Can I make phone calls during the study?	Free local phone calls are permitted during the study provided that they do not interfere or delay any test procedures. Cell phones may interfere with the medical equipment used in the study, so please check with the clinic staff before using any wireless communication devices such as cell phones, pagers, blackberry type devices etc.
14	Is smoking allowed?	For some studies, smokers are permitted but smoking is not allowed in the building or for the duration of the overnight visits at our clinic.
15	What are the benefits of participating in clinical studies?	There are many benefits to participation, including: - becoming active in your own health - helping others by contributing to medical research - gaining access to leading-edge treatments that are not yet available to the public - obtaining expert medical care and attention during the study - meeting new people - financial compensation in some studies
16	What happens during screening? How long will it take?	The screening process typically lasts at least two hours. You must read and understand the informed consent - a document that outlines the study procedures, risks and benefits of the research. After you have read the informed consent, you will be given an opportunity to discuss the study with the coordinator/nurse to answer any study related questions. The study medication is discussed with you so that you become fully informed about the purpose and possible side effects of the medication that you will receive. You will also be given enough time to fully consider participation in the study before signing the informed consent. You will meet with an Ontario certified physician to discuss the study and a physical exam (no pap or internal exams) will be performed; an electrocardiogram (an electrical tracing of your heart) and blood work will also be done to determine if you are eligible for the study. Finally, the coordinator/nurse will discuss and confirm the study schedule with you.
17	What is the Independent Review Board (IRB)?	An IRB (Independent Review Board) is made up of healthcare professionals and local community members who review and approve all clinical research studies before they begin. This committee's primary responsibility is to protect the safety and rights of study participants and scrutinize all study activities with those principles in mind. All studies must have IRB approval before they may proceed. This committee may also be referred to as an EthicsCommittee, an Ethics Review Board or a Research Ethics Board.
18	When do study participants receive their compensation?	Many studies provide compensation to the participants at the follow-up visit. However, other schedules of payment are also used and depend on the type of study being done.
19	What kinds of staff are on hand?	Our supervisory staff are all Registered Nurses, trained in emergency situations. Physicians are on site during the day, on dosing days and on call for overnight studies. We have specialists for specific studies such as dermatologists for skin disorder studies.
20	Can clinical study participants still see their regular doctor?	You can and should continue to see your regular physician. Clinical studies do not replace or interfere with normal health care.
21	How is a drug approved for testing?	All clinical research studies in Canada must be authorized by the Health Products and Food Branch (HPFB) of Health Canada. In the U.S. it is the Food and Drug Administration. A pharmaceutical company must have their proposal for a clinical research study approved by one of these authorities before proceeding with study in their respective countries.
22	How long will the study be?	The length of the study depends on the type of research. Treatment studies are done on an out-patient basis and healthy volunteer studies have overnight visits. This information is provided to you at the initial telephone contact with the Recruitment department.