Why participate in a clinical trial?
Volunteers are an essential part of clinical trials and drug development. There are many positive reasons why you should become a volunteer. As well as getting paid for your time, there is also a feeling of satisfaction that you have been part of the development of a potential medication.

What type of studies do you run?
Some BioKinetic Europe studies involve routine visits to our clinic and others will involve a stay at our clinic. This stay is to ensure that volunteers follow the guidelines required in the clinical trial. 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 are served each day. BioKinetic Europe staff are on duty at all times to assist with the programme details and all possible measures are taken to ensure the safety and comfort of volunteers.

How can I register with BioKinetic Europe?
The best and most convenient way to register with us is to register your interest online, call our recruitment team on 028 90818385 or send us an email to enrol@biokineticeurope.com. It takes usually takes around 5 minutes, once registered we can give you details of studies that you are suitable for.  

How will I be kept up-to-date with upcoming trials?
We advise all healthy volunteers to contact us every 6 - 8 weeks to keep up to date with our current studies. The majority of our studies are for healthy volunteers aged between 18 and 55 however, we do have studies from time to time for smokers, over 55s and those with medical conditions. If your circumstances change, let us know so we can keep your details relevant and up to date.

Is it safe to enrol in a study?
All studies conducted at BioKinetic Europe are reviewed and approved by a Research Ethics Committee (REC) and the MHRA (UK Regulatory Body) before the study can begin.  The REC is an independent body composed of medical and lay professionals who carefully review each trial solely with the safety of a volunteer in mind. The MHRA focus is primarily on the scientific merit of a study. BioKinetic Europe only conduct studies approved by both.

Taking part in a study for the first time?
If you are taking part in a study for the first time you might feel a bit uncertain. Your screening (medical) appointment is a great opportunity to ask any questions you might have in relation to the study drug and to gain a better understanding of what is expected of you during your participation in the study. Some things you might want to consider before attending a screening appointment are:

• What is the purpose of the study?
• What kinds of tests are involved?
• Are there any potential side effects?
• How long will the trial last?
• How much will I be reimbursed for my time?
• What kind of preparation should a I make for attending my screening?
• Plan ahead and write down possible questions to ask!.

What is an ICF?
An ICF is an Informed Consent Form and records the process of obtaining your consent to take part in the clinical trial. In addition, you will be supplied with detailed trial information so that your decision to take part is an informed one.

How can I increase my chances of getting a study place?
Every person who fits the criteria for the study and who passes the medical examination, has an equal chance of being offered a study place. You can however increase your chances of passing the medical examination by following the preparation for your medical guidelines listed below.

FASTING
You will be required to fast for 8* hours prior to the pre-study blood and urine sample. This means no food and drink, apart from water, for 8* hours before your appointment and until after your blood sample has been taken. (*Fasting time is study specific and may increase depending on the protocol requirements)

MEDICATION
Usually you cannot be on other medication, prescription or over-the-counter, apart from HRT or oral contraceptives, for 14 days before your pre-study medical appointment and until you have completed the study. Again there may be study exceptions to this. 

ALCOHOL
Strictly no alcohol for 48 hours before your pre-study medical appointment.

EXERCISE
No strenuous exercise (i.e. running, work-outs etc) for 48 hours before your pre-study medical appointment. Strenuous exercise can sometimes temporarily change your blood results which could mean you might not pass your medical.

DRUGS OF ABUSE
A sample of urine will be taken at your pre-study medical appointment to test for drugs of abuse (e.g. cannabis, cocaine, amphetamines). Additional tests for smoking and alcohol will also be conducted. A positive result will exclude you from the study and may exclude you from taking part in further BioKinetic Europe studies.

DENTAL TREATMENT
No dental treatment requiring a local anaesthetic for 14 days before your pre-study medical appointment and until you have completed the study. No general anaesthetic is allowed during the 3 months before the start of the study.

BLOOD DONATIONS
No blood donations are allowed during the 3 months before the start of the study.

What is involved in a screening (medical) appointment?
The screening involves a free, confidential physical examination. Certain studies may include blood and urine samples, and other diagnostic tests. These procedures are carried out to ensure that you do not have any medical problems which would make it unsafe for you to participate. Results of all tests are confidential.

How long will screening last?
In order to allow for the informed consent (see FAQ What is Informed Consent?) and the required medical procedures, a screening session normally lasts around 2 hours. During your screening appointment you will also have the opportunity to look around the clinic and see where you will stay, if an overnight stay is required for the study. 

Will I be paid for attending screening?
As a general rule you will not be paid for attending screening, as at this stage your suitability for study participation is being assessed.

What do I need to bring to screening?
You will need to bring the following things to screening with you:
I.D. – photographic I.D. is required such as a Passport or Driving Licence
Proof of your national insurance number – such as; your national insurance card, a letter from the DHSS, a payslip or P45/60. This is a means of identifying you and to ensure that you are not over volunteering.
Doctor's details – There will be a place on the form for you to provide your doctors contact details including the practice phone number.

Do I need to be registered with a doctor?
Yes, as we generally get in touch with your GP once you have attended screening. This will be to inform them that you may be taking part and to discover if there is anything relevant in your medical history that may affect your ability to take part in a particular study.

How will I spend my time while on a study?
Each study is well thought out to ensure that all study procedures are carried out at precise times. When you are not required for study procedures you will have time to relax. To help you do this we provide games, books and magazines, along with daily newspapers. There is also Sky Television, a DVD player and a games console available in the clinic.

What can I bring with me?
You need to bring enough comfortable clothes and toiletries for the duration of your stay. You can also bring books, mobile phones, i-pods/mp3 players and laptops. However, this is dependent on the type of study and all electrical equipment must be switched off during clinical procedures.

Is there anything I should not bring?
Food and medication (apart from HRT and Oral Contraceptive pill - if allowedl) are all prohibited in the clinic.

What can I eat?
For study that requires stays in the clinic all food will be provided. At screening you will be provided with a menu. You should carefully review the menu to ensure that you are happy to eat all of the food provided

How should I dress?
Dress in comfortable clothing, as ECGs are usually a part of study procedures you may want to consider wearing loose fitted tops. Footwear must be worn at all times in the clinic, soft soled shoes are preferable.

Is there parking available?
BioKinetic Europe is in a prime location in the heart of Belfast city centre, therefore we recommend you leave your car at home and use public transport if you are staying overnight. BioKinetic Europe is based just a few minutes’ walk from both Great Victoria Street train station and the Europa bus station. A Metro service to the Greater Belfast Area is also available from the City Hall which is close by.

You can find further details on all these services by following the link below:
www.translink.co.uk/

If public transport is not suitable for you there are a number of car parks in the immediate area.

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 often can I take part in a study?
There is a minimum period of 90 days allowed between finishing one trial and starting another; you can screen for a new study within this timeframe but cannot be dosed.

It is important for your own safety that you are open and honest about previous study participation. Failure to disclose recent study participation will mean that you will not be permitted to take part in studies with us.

Where can I get independent information about clinical trials?
Below are some useful link the regulatory bodies associated with clinical trials:
http://www.mhra.gov.uk/index.htm
http://www.nres.npsa.nhs.uk/patients-and-the-public