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01.What is Bio-Kinetic Europe?
02.Why participate in a clinical trial?
03.Is it safe to enrol in a study?
04.How do I go about enrolling ?
05.What type of medicals are involved?
06.What type of studies do you run?
07.Do I get paid for this?
08.Is there anything I need to do before the study
begins?
09.May I continue to take vitamin supplements or
any medication until checking on for the study?
10.May I continue to donate blood?
11.What activities are there for me to do while
on the study?
12.Is smoking allowed?
13.Are visitors permitted?
14.How should I dress?
15.Are there urine drug screens for all of the studies?
16.What items should I bring for the study?
17.Is there anything I should not bring?
18.What can I expect during the study?
What is Bio-Kinetic Europe?
Bio-Kinetic Europe is an independent company which tests a wide
variety of pharmaceutical products. Bio-Kinetic conduct medically
supervised testing of products, mostly on persons who are healthy
and in good medical and physical condition. Occasionally studies
are conducted on persons with specific medical conditions such
as Asthma, High Blood Pressure and Diabetes.
Why participate
in a clinical trial?
Pharmaceutical companies are constantly changing and improving
everyday shelf and prescription medicines, thereby improving the
quality of life for many people. A large number of these medicines
are evaluated by independent testing laboratories before they
can be marketed. This type of testing helps to assure you, the
consumer, that the medicines you purchase are effective and safe.
Is it safe to
enrol in a study?
All studies conducted at Bio-Kinetic Europe are reviewed and
approved by a Research Ethics Committee before the study can begin.
The Ethics Committee are solely concerned with the welfare of
volunteers. If the Ethics Committee does not approve a proposed
study, then Bio-Kinetic cannot conduct the study.
How do
I go about enrolling?
To enrol on a study with Bio-Kinetic Europe volunteers must meet
some simple criteria as required by the study, have free time
and agree to follow straightforward instructions. Before entering
into a study all volunteers will receive full information about
the nature of the study, the drug which is being tested and will
be given an opportunity to ask questions about any aspect of the
study. A detailed information sheet will be provided prior to
participating.
What type of medicals
are involved?
The testing involves an initial free, confidential physical examination.
Certain studies may include blood and urine samples, electrocardiograms
(ECGs) and other diagnostic tests. The tests are done to ensure
that the volunteers do not have any medical problems that would
make it unsafe for them to participate. Results of all tests are
confidential.
What type of studies
do you run?
Some Bio-Kinetic studies involve routine visits to our clinic,
others will involve a stay at our clinic. This stay is to ensure
that volunteers follow the guidelines set down by the pharmaceutical
company. The clinic is equipped with beds, showers, phones, and
a lounge area. During the stay, volunteers will have free time
to relax, study, read or watch television. Meals will served each
day. Bio-Kinetic staff are on duty at all times to assist with
the program details and all possible measures are taken to ensure
the safety and comfort of volunteers.
Do I get paid
for this?
Participating in a Bio-Kinetic study is a simple means of earning
extra money. The payment for each study varies. It will be determined
by several factors including the number of hours/days spent at
Bio-Kinetic, the number and type of tests and procedures and the
number of return visits required to the clinic.
Is there anything
I need to do before the study begins?
There will be specific guidelines for each study. These may include
no alcohol or caffeine consumption and no medication for a period
before the study starts and before physical examinations.
May I continue
to take vitamin supplements or any medication until checking on
for the study?
Avoid taking all medications for 7 – 30 days (as determined
by the study).
May I continue
to donate blood?
Donations can be made up to 90 days before the start of the study.
What activities
are there for me to do while on the study?
There is a television, video and games console in the clinic.
Games, books and magazines are also available as are daily newspapers.
Exercise is limited because of the way it affects absorption of
the study medication.
Is smoking allowed?
In general the clinic is a non-smoking facility. Smoking is only
allowed on certain studies within designated areas.
Are visitors permitted?
Visitors are not allowed except to bring clean clothing, personal
care items or books, etc. Telephones are available for both incoming
and outgoing calls.
How should
I dress?
Dress in comfortable clothing. Footwear must be worn at all times.
Are there urine
drug screens for all of the studies?
Urine drug screens are done at the physical examinations and
every check-in. Avoid all drugs (e.g. cannabis), medications and
alcohol. A positive drug screen will eliminate you from the study.
What should I
bring for the study?
Bring all personal care items, (soap, towel, shampoo, clean clothing)
books, magazines and puzzles; etc. Bedding is provided.
Is there anything
I should not bring?
Food and medication are all prohibited in the clinic. Meals will
be provided.
What can I expect
during the study?
Every test is done in volunteer order (i.e. number 1, number
2) and timed precisely. At the beginning of the study you will
be given an arm band displaying this number and a schedule of
tests and times. When you are not involved with study procedures
you are free to relax.
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