How safe is it?
Clinical trials are heavily regulated. To ensure that the highest standards of safety are maintained, trials are required to comply with strict guidelines. These are governed by the EU Clinical Trials Directive and the MHRA (The Medicines and Healthcare products Regulatory Agency) and are approved by an Independent Research Ethics Committee before they can be used in Healthy Participants and Patients.
What happens first?
The process begins with an assessment of the participant's general health. If suitable, the participants will be invited to come into The Centre to learn more about the study. At the same time, participants will have a general health check to assess their suitability, meet the clinical team and have an opportunity to ask questions.
What is informed consent?
Participants are required to sign a consent form before participating in a research study. The purpose of the informed consent process ensures that volunteers are fully informed and understand all aspects of the research.
Who can take part?
Males and Females of all ages can take part, depending on the criteria required for the research study. The age range of 18 to 45 is more common for healthy participant studies and females of childbearing potential may be required to use contraceptives. Participants will be asked to bring in a form of photo ID on their visits. (Passport, driving license).
What sort of drugs do we test?
Many studies run at Surrey Clinical Research Centre look at how medications affect the central nervous system, which is the part of the body which has a role in the control of behaviour. The Centre specialises in sleep research, testing existing medication or new medications designed to help sleep. We’re also specialists in running vaccine studies and look at the immune response after administering vaccines to healthy participants. These clinical vaccine studies are designed to improve our understanding of the way our bodies respond to vaccinations and may be helpful in the future development of new vaccinations which offer protection against a number of important infections. The vaccines are administered on separate outpatient occasions via several different routes including intramuscular injections in the arm or leg and nasal gel administrations.
How long do studies last?
The length of studies may vary considerably depending on the type of research and medication being tested. They can be fully residential, short out-patient visits only, or a combination of both.
How often can I take part?
Healthy participants should normally allow 3 months between research studies. However, as the time is determined by the criteria of a particular study, the gap may be longer or shorter.
Will I be paid for taking part?
Participants will receive some compensation in recognition of the time spent in The Centre and reimbursed for their travel expenses.
Do I need to be registered with a doctor?
Participants are required to be registered with a GP/Doctor. Surrey Clinical Research Centre will contact the participant's doctor to obtain current and past medical history details and information on any prescribed medication. A GP/Doctor may be reluctant to release medical details if the participant has not been registered or visited the surgery for long time.
Will I be allowed to leave the building?
Participants on residential studies will not be allowed to leave The Centre until all procedures have been completed or as specified by the clinical staff.
Can I drink Alcohol / Tea or Coffee?
Restriction for both alcohol and caffeine will depend on the research study. As a general rule alcohol should be avoided 24 hours prior to screening and during a study, and participants may be required to take an alcohol test. Participants may be asked not to eat or drink anything containing caffeine throughout the study, this would also include chocolate and cola/sports drinks.
Can I smoke?
Restrictions will depend on the criteria of the study and volunteers will be informed prior to coming into the unit. Smoking or light smoking may be permitted, however there is a no smoking policy at The Centre.
Can I exercise?
Restrictions will depend on the research study and participants will be informed prior to coming into the unit. As a general rule exercise should be avoided 24 hours prior to screening, and throughout the study. Participants may be asked not to make any major changes to their normal exercise routine whilst taking part.
Do you cater for Vegetarians/Vegans or special dietary requirements?
As a general rule an alternative vegetarian meal would be available, however this is determined by the criteria for the research study. Participants may be required to avoid certain foods.
Will I be tested for drugs?
It is standard practice on most clinical research studies to be tested for recreational drugs, which includes testing for cannabis, "Es", hard drugs etc. It is recommended that participants avoid foods containing poppy seeds as this may affect drug results. Please note: cannabis can stay in your system for at least 3 weeks.
Will I be tested for HIV and Hepatitis B & C?
It is standard practice on most early phase studies to be tested for HIV and Hepatitis B and C. The results of these tests remain confidential.
Are there contraceptive requirements?
Restrictions will depend on the research study and participants will be informed prior to coming into the unit. As a general rule female participants of childbearing potential will need to be using a double barrier method (e.g. contraceptive pill combined with a condom). Pregnant or breastfeeding females will not be able to take part. Male participants may be asked to use contraceptives before/during/after a study for a specified time.
Can I use my mobile phone / laptop?
Mobile phones / laptops and chargers are acceptable but their use is greatly restricted as they interfere with our sensitive equipment. Participants may be asked to switch them off according to study requirements.
What do I need to bring with me?
Sufficient daytime clothing as we are unable to wash any laundry. Clothing with front fastenings may be required if participants are having electrodes placed on their heads and warm clothing for sleeping as our sleep labs are kept at approximately 18ºC. Shoes/soft shoes must be worn at all times for safety reasons. (i.e. you cannot walk around in bare feet)