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If you are participating in a study or trial at the CRF the following information may be useful. If you have further questions about your participation please contact us directly:
Email: oxfordhealth.CRF@nhs.net
Telephone: 01865 902 135
[section=What to expect during your first research visit]
Before you can take part in a research study, we first need to check that the study is right for you with a ‘consent and screening visit’.
Your visit may be different depending on the type of study you are taking part in, but most consent and screening visits will follow this structure:
- On arrival at the Clinical Research Facility (CRF), you will be greeted by our administrator who will confirm a few details with you. You will then be asked to wait in our waiting room where a member of our study team will come to meet you in the waiting room and take you to a private room situated on the CRF.
- Consent procedures
You may have been given an information pack about the study to read prior to this visit. Our staff will check that you have understood the information, further clarify important aspects of the study and answer any questions you may have. If you are happy to proceed, you will be asked to sign a consent form indicating that you wish to participate in the study. You can withdraw from the study at any time. If you do wish to withdraw, your decision will not impact your health care plan in any way. - Screening
If you do wish to proceed, we will then check that you meet the criteria for the study to make sure it is suitable for you. This is different for all studies but may involve taking a full medical history, record of current medication, and/or physical health assessment. Depending on the type of study you are participating in, a mental health or neurological assessment may also be necessary. Some studies also require biological samples (such as blood, urine) which we will send for testing. You will be informed what the screening procedure involves for your particular study before you consent to take part. - Eligibility
For some studies we will be able to tell you straight away whether you are eligible for the study and you will be able to proceed with the study that same day or book in another visit. However, for other studies we need to wait for the results of testing first so the study coordinator will contact you after your visit to inform you of the outcome. We can then arrange the next steps for your study.
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[section=Roles of research staff]
During your research visit you may see several members of staff throughout the day. This is because we are a multidisciplinary team with different roles and skills, so assessments are carried out by those who are best trained for the task.
People you may come into contact with during your participation in a study:
Psychiatrist: our psychiatrists, or ‘medics’, are trained medical doctors and have advanced clinical skills, knowledge and professional training in physical and mental health. Psychiatrists can navigate and guide research staff on complex clinical issues. The psychiatrist will assess the medical history of both physical and psychiatric conditions, carry out physical examinations (including neurological), review results of investigations, conduct standardised interviews and assessments, and assess the safety and eligibility to proceed in studies.
Research Facilitator: Research Facilitators (RF) organise all aspects of a study and liaise closely with investigators and senior managers to deliver studies. RFs are actively involved in the completion of participant visits ensuring they run smoothly and in accordance with the rules and procedures set out in the study protocol.
Research Nurse: Research nurses are clinically registered members of staff who lead in the day-to-day running of studies and work closely with RF’s to meet study targets. Research Nurses have clinical experience, skills and knowledge to carry out assessments and procedures during study visits. Research Nurses also work together with participants, carers and medical doctors to ensure the safety and protection of patients throughout the research study.
Research Assistants/Research Nursing Assistants: Research Assistants (RA) and Research Nursing Assistants (RNA) support clinicians, to deliver studies and work in collaboration with participants and carers throughout the research study. RAs and RNAs have a working knowledge of the study procedures and help to ensure participants are safe and fully informed. RAs and RNAs are trained to carry out assessments and procedures on study participants including cognitive assessments and the collection and processing of biological samples (including blood and tissue samples).
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[section=Jargonbuster]
Active comparator
A known intervention or treatment that is considered to be effective. This may be an active medicine or a therapy that is already used as treatment. Active comparators may be used as a comparison to investigational interventions, such as a new therapy or medicine.
AD – Alzheimer’s disease
A disease that causes dementia and the most common cause of dementia.
Arm
A group of participants in the trial who receive a specific intervention or treatment. If there are multiple treatments or comparisons, these may be referred to as study arms.
Assessment
A procedure such as a blood test, interview, questionnaire or scan, used to generate data required by the trial.
Blinding
An aspect of a clinical trial design where one or more parties involved does not know which treatment participants have been assigned to. For example, neither the research staff nor you as the participant know whether you are receiving a study medication or placebo/active comparator.
Cognitive tests
Cognitive tests are designed to measure aspects of brain function such as memory, language, learning, judgement or attention. Cognitive tests may be done electronically or on paper, and usually involve answering questions or performing tasks. They are a part of many of the studies we run, and are conducted by various members of the research team.
Control
Control is the term used for a comparison to an investigational treatment. For example, the control of a study medication would be a placebo or an active comparator substance. The control of a novel therapy would be an existing therapeutic approach.
CRF – Clinical Research Facility
Clinical Research Facilities are dedicated facilities for specialist clinical research.
Ours is specifically called the NIHR Oxford cognitive health Clinical Research Facility, based on our funding from the National Institute of Health Research (NIHR) and our focus specifically on cognitive health research.
Demographics
Statistical data relating to participants. For example, age, race, ethnicity, gender, marital status, education and employment.
ECG – Electrocardiogram
A simple and non-invasive test used to check heart rhythm and electrical activity. Sensors are placed on the skin on your chest, arms and ankles. These sensors are attached to a machine via leads, and together they record a reading of your heart. ECGs are part of many research studies and various members of the research team are trained to conduct them.
Eligibility criteria
A list of requirements or characteristics that mean you are suitable to take part in a clinical trial. These requirements must be met in order to participate.
Exclusion criteria
A list of characteristics that would exclude you from participating in a particular clinical trial. These are due to the nature of a specific study or for safety reasons.
ICF – Informed consent form.
Once you have read the participant information sheet (PIS) and had the opportunity to discuss a trial with a member of the research team, if you wish to proceed with participation, you will be provided with an informed consent form.
Informed consent forms are designed to clearly state what you are agreeing to as a research volunteer and require you to sign next to these agreements. It is not a contract; you can withdraw at any time.
Investigator
The word commonly used for a researcher involved in a study. This may be a research assistant, a research facilitator or a nurse. Please see our list of roles for more detail on their differences and the skills needed for each profession.
Observational study
Not all studies are testing a medicine or an intervention. An observational study investigates health outcomes in a group of people over a certain time period but does not add anything to see if they can alter these outcomes.
Participant ID
A number generated to identify you in a study that enables you to remain anonymous. Identifiable details are not associated with your study ID.
PIS – Participant information sheet.
A document that explains all the information about a study so that participants can understand the requirements and expectations should they take part.
Placebo
A medication that looks the same as the investigational product but is in fact an inactive substance. A placebo may be used as a comparison to an investigational drug treatment.
PPI – Patient and Public Involvement
A partnership between patients, the public and researchers, outside of research participation. This includes involvement in research design, delivery and facilities.
Randomisation
The generation of a random sequence which allocates participants to a treatment group within a study. This is done by computerised systems so that there is no external influence or control.
Re-consent
Sometimes research teams make changes to a study in terms of procedures, data management or other aspects of how it is conducted. This means that we would need you to provide written consent on a second occasion.
In the event of a change to a study, you would be provided with another participant information sheet (PIS). A member of staff would explain the changes to you and discuss whether you are still willing to take part. If you wish to continue, you would sign another consent form (ICF), in the same format to when you initially enrolled in the study.
Sponsor
The organisation who oversees multiple sites who conduct the trial.
Screening
The screening process involves the research team assessing your suitability for a specific trial.
During a screening visit, a member of the research team would go through the study with you and if participation is agreed, you would sign the consent form. You may be asked various questions about your medical history, have measurements taken, or be asked to provide a blood sample.
Subject
Another word for a research participant.
TRD – Treatment-resistant depression
Defined as depression that has not been helped with antidepressant medication.
Further information on this topic can be found on the following websites:
– clinicaltrials.gov
– novartis.com
– NIHR Involve
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[section=How to find us]
The Oxford cognitive health Clinical Research Facility is situated at the Warneford Hospital, Warneford Lane, Headington, Oxford OX3 7JX.
We are located directly to the left of the hospital’s main reception. You will see our sign to the left of the door – Oxford cognitive health Clinical Research Facility
Getting here
Car parking and bicycle storage are available at the Warneford Hospital site.
Please note parking is limited during peak hours.
Car parking charges are shown in the table below. Unfortunately, we are currently unable to accept payments by cards or notes and no change for coins is given. Please ensure you have the correct change in advance of your visit.
| Up to 30 mins | Up to 1.5 hrs | Up to 2.5 hrs | Up to 3.5 hrs | Over 3.5 hrs |
| Free | £1.00 | £2.00 | £3.00 | £4.00 |
Public transport options
- Oxford offers ‘Park and Ride’ sites around the city, equipped with many cark parking spaces to leave your vehicle and catch the bus. For more information on fares, locations, timetables and other details, visit the website:
https://parkandride.oxfordbus.co.uk/where-to-park/
- Coach services to Oxford are available from various locations via national express and there are additional services from London via the Oxford tube:
www.nationalexpress.com
www.oxfordtube.com
- Oxford train station is located near the city centre and requires further transportation to Headington. Please visit the national rail site below for information about the train station and onward travel, including bicycle hire: https://www.nationalrail.co.uk/stations_destinations/OXF.aspx
- For more information on cycle routes:
www.oxford.gov.uk
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