If you can't find the answer to your question here, please do
not hesitate to call on 08000 718 265 (Nottingham) or email
us at recruitment@quotientbioresearch.com
Clinical trials with
Quotient
How soon will I know if I have been accepted onto the
trial?
You will know at the end of the medical if you have been put
forward to participate in the trial, however selection of the
volunteers who will actually be given the study medication will
depend on the results from your screening and admission blood
samples and also on information we receive from your GP.
When and how do I get paid?
Trial participation fee - All fees are paid by crossed cheque in
your name or directly into your bank account. Please note that
cheques are not issued until after the final day of the study.
Can I leave the unit at all when I am on the
trial?
No, whilst resident in the clinic you will be required to stay
on-site. On many trials, depending on weather conditions and
staffing levels, volunteers may get the opportunity to go on a
supervised walk. Participation in any clinical trial is entirely
voluntary and you are free to withdraw your consent at any time,
however you are encouraged to talk to the study doctor or nursing
staff first and you may be asked to return to the clinic for a
follow up visit to check your health.
Do I need to bring in my own food?
No. Due to study requirements there are dietary restrictions
usually in the form of calorie controlled meals. No additional or
substitute food or drink may be taken while you are resident in the
clinic. If you are vegetarian or have other dietary restrictions,
please inform nursing staff at screening and on admission. On some
occasions there will be a restriction on alcohol, caffeine and
chocolate prior to admission. You will be advised of any such
restrictions when you visit for your pre-study screening
appointment.
What do I need to bring with me for the
study?
Toiletries - washing/shaving items, towels, toothbrush and
toothpaste. Please note that mouthwash must not be used during your
stay in the clinic as it affects some sample results.
Clothing - The majority of your stay will be spent within the
clinic and as such you should bring comfortable clothing and
nightwear. For safety and health reasons footwear should be worn at
all times in the clinic. Please do not bring any football colours,
as these should not be worn within the clinic. You will also need
to bring suitable clothing for all walks. Cigarettes/tobacco -
only if allowed on study.
What is there to do all day?
When you are not required for any trial procedures, there are
recreation rooms available. There is satellite
television, DVDs, videos and various board games. If you wish to
bring videos/DVDs with you, please ensure they are of suitable
material for general viewing and clearly marked as your own
property.
Please remember that Quotient Clinical does not accept
responsibility for loss or damage to personal property. We do have
internet access for volunteers, however there are restrictions on
its use. We supply daily newspapers and some magazines, but please
feel free to bring your own reading material.
Can I have visitors?
Visiting is restricted on some studies so please ask if there
are any restrictions when you attend for the screening medical.
Travel expenses
You will be reimbursed for all journeys from your address held
on our database. These will be paid when you attend the clinic e.g.
for screening, admission, outpatient visits.
We have set expense rates dependent on the area of the country
you live.
Can I bring my laptop computer?
Yes. Please note that you are responsible for the safety
of your personal belongings in the clinical unit.
Where can I leave my car when I am staying in the
clinic?
We have car parking facilities where you can leave your car
for the duration of the study. However, Quotient Clinical
accepts no responsibility for any loss or damage to your vehicle
whilst parked in the car park.
Do I have a room of my own?
No, you will stay in a ward with the other volunteers on your
trial.
What is a follow-up visit?
This is a visit where you will return to the clinic, but you
will not be required to be resident overnight.
Are telephones allowed in the clinic?
There are pay phones in the clinic which accept incoming calls.
Mobile phones are generally prohibited from use in the wards but
may be used elsewhere in the clinic. However mobile phones that
take and send images are not permitted anywhere in the clinics and
neither are cameras.
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Volunteer
safety
Will I be told everything about the trial?
Yes, before participating in any trial you will be required to
attend the clinic for a pre-study medical/screening visit. These
appointments are specific to the trial you are going to participate
in and, as such, you will need to attend a medical prior to each
trial you wish to take part in. At this medical you will be given a
document about the trial called an Informed Consent Form. You
will be given time to read this and the screening staff will also
go over this with you to ensure that you understand the information
and to confirm that you are completely happy with the contents.
What side effects might I expect?
We would not anticipate any long-term side effects following
participation in a trial. The common short-term side effects are
headaches, backache, indigestion and drowsiness although some of
these may be related to the clinical environment. Any specific side
effects will be discussed with you at your pre-study medical.
Who is the MHRA?
The safety and well-being of our volunteers is at the forefront
of everything that we do. Our trials are strictly regulated by the
Medicines and Healthcare products Regulation Agency (MHRA), an
independent body not influenced by the pharmaceutical industry.
What does the Ethics Committee do?
Each trial is also reviewed by an Independent Ethics Committee,
made up of expert members, e.g. doctors, pharmacists etc, and 'lay'
people, who are responsible for ensuring that your safety has been
thoroughly considered, that the information provided to you is
fair, balanced and accurate - and that your rights as a volunteer
are maintained.
What is Informed Consent?
Before you participate in a trial, all aspects of the trial will
be explained thoroughly to you - including any risks/benefits of
the trial - before obtaining your informed consent.
Signing an Informed Consent Form does not obligate you to
participate in the clinical trial. You may change your mind and
leave a trial at any time, without providing any explanation.
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Data
protection and Privacy
Is my personal data securely stored?
All data is stored securely and in accordance with the Data
Protection Act
How do I remove my details from the Quotient
database?
Simply contact us by phone or email and we will remove
your details from our database
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General
Who pays for clinical trials and medical
research?
The majority of clinical trials are funded by
pharmaceutical companies who are testing new products, however a
variety of different organisations might pay for trials to take
place including the NHS or Medical Research Council, Charities e.g.
Cancer Research UK or government bodies e.g. Department for
International Development.
What does the clinical trials process
involve?
All new drugs must complete a series of tests before they can be
prescribed by doctors, or sold in pharmacies and chemists' shops.
The work undertaken by Quotient Clinical is part of the
testing process. Before any clinical trial can take place, the new
drug undergoes extensive pre-clinical or laboratory tests. As a
result, a Phase I clinical trial will not be started unless experts
believe that it is safe to proceed to clinical trials.
Phase I studies are usually conducted in a small number of
healthy volunteers (someone who does not have any medical
conditions and is deemed therefore to be healthy). In the majority
of Phase I studies, volunteers are given a new medicine.
Phase II trials usually involve 200 to 400 volunteer patients
who have the disease that the trial drug is designed to treat.
During this stage of testing the drug's effectiveness is assessed
as well as more safety testing and monitoring of the drug's side
effects.
Phase III trials also involve volunteer patients who have the
disease that the trial drug is designed to treat but the number of
patients included in these trials is significantly more than Phase
II - some trials include thousands of patients. Trials in
this phase usually compare the new drug's effectiveness with either
a placebo or existing drugs and as patients are usually followed up
for an extended period the trial gives a more reliable indication
of whether the drug will work in addition to allowing long-term
side effects to be identified.
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