Your journey as a Volunteer
WE WILL BE IN TOUCH
Our Recruitment team will contact you about your application and clinical trials you may be eligible to participate in. We’d like to get to know you and make sure we have all the information we need. If we think you are eligible for any clinical trials, you will also receive a Participant Information Sheet which provides an outline and further information about the trial.
TELEPHONE PRE-SCREENING
We will ask you questions about your medical history and lifestyle to see if you may be eligible to take part in the clinical trial. You will have the opportunity to ask questions, discuss your availability and find out more about the trial.
INFORMED CONSENT
Before you decide to join a clinical trial, you will have the opportunity to talk to other people you feel comfortable with such as family, trusted friends, or your doctor about your participation. If you decide to participate, when you come into the Unit you will be asked to sign a consent form. This is called Informed Consent. By signing the Consent Form, you are agreeing to participate in the clinical trial. Our medical team will be happy to answer any questions you have about the clinical trial and give you as much time as you need before signing the consent form.
SCREENINGS TESTS & MEDICAL
While in the Unit, our medical team will undertake medical tests (e.g. blood, urine, and other trial-specific test) to determine whether you meet the criteria for the clinical trial and that it will be as safe as possible for you to participate.
ELIGIBILTY DECISION & PRE-TRIAL REQUIREMENTS
Once all your test results are in, our medical team will be in touch to confirm whether you are suitable for the clinical trial. They will also share with you any pre-trial requirements (e.g. not consuming alcohol) and confirm the logistics for your trial.
CLINICAL TRIAL ENROLMENT
Your enrolment into the clinical trial is typically within 28 days of your Screening appointment. Clinical trials differ in their design and therefore require different levels of time and commitment. For example, some trials just ask for a blood sample, some involve outpatient visits, and some require one or more overnight stays in our research Unit.
CLINICAL TRIAL PARTICIPATION
During the clinical trial you will undergo certain trial procedures and your safety will be monitored throughout by our medical team. There are facilities and free WiFi to accommodate either remote working or relaxation when you are not occupied with trial procedures. You can find out more about our facilities below.
Step 1 of 7
Meet the Team
Our team of experts are here to support you and ensure you receive appropriate medical attention throughout your clinical trial journey.
Recruitment & Screening Teams
Our recruitment and screening teams are a combination of administrative and clinical staff, some of whom are nurses and healthcare technicians, who have great experience of recruiting and screening volunteers to our clinical trials.
Physician Team
Our physician team is responsible for the overall clinical trial. Physicians manage the day-to-day care and safety of our clinical trial volunteers.
Clinical Ward Manager Team
Our clinical ward managers are a combination of nurses and healthcare technicians who have the responsibility for your day-to-day care whilst you are on a clinical trial.
Our Clinical Research Unit
Visits will take place at our Clinical Research Unit (Clinical Unit Cambridge) within the site of Addenbrooke's Hospital in Cambridge.
During visits, you will have easy access to
Stay Connected
• Unlimited WiFi
• 2 private pods for phone calls and working
• 2 private pods for phone calls and working
Food
All your meals during your stay are prepared by our on-site chefs, who can cater for any dietary requirements. Enjoy restaurant-standard food, cooked fresh every day.
Leisure
• Entertainment (Xbox, PS5 and a pool table)
• BT Sport and full Sky TV Package
• Comfortable areas to work and relax
• Books, newspapers, board games and DVDs
• BT Sport and full Sky TV Package
• Comfortable areas to work and relax
• Books, newspapers, board games and DVDs
Hygiene
• Laundry service (for longer stays)
• Shower facilities
• Shower facilities
Storage
Secure storage for your belongings
What are Clinical Trials?
Clinical trials are medical research performed in people. Most clinical trials investigate whether a new medicine is safe and effective for the treatment of a medical condition. Though, some may also help our understanding of disease processes.
FAQs
When we start a clinical trial, we invite volunteers who match the trial requirements (for example, healthy males and females aged 18 to 65 years) either from our panel of Clinical Trial Volunteers or those who have responded through advertising to learn more about the trial. This is usually done by email. If you are interested, we will invite you to our Clinical Unit in Cambridge to learn more about the trial at an informed consent talk.
At the informed consent talk, you will have the opportunity to have a comprehensive discussion with staff and ask any questions you may have about the trial. If your questions are answered to your satisfaction and you decide to participate, you will undergo a medical assessment and some investigations, such as blood and urine tests, as part of this process. This is to ensure that you are healthy and that it will be as safe as possible for you to participate. It also ensures that you meet the criteria of the trial. Once both these conditions are met, you will be invited to be enrolled in the trial. This is usually within 28 days of your screening visit.
At the informed consent talk, you will have the opportunity to have a comprehensive discussion with staff and ask any questions you may have about the trial. If your questions are answered to your satisfaction and you decide to participate, you will undergo a medical assessment and some investigations, such as blood and urine tests, as part of this process. This is to ensure that you are healthy and that it will be as safe as possible for you to participate. It also ensures that you meet the criteria of the trial. Once both these conditions are met, you will be invited to be enrolled in the trial. This is usually within 28 days of your screening visit.
The safety of the volunteers in our clinical trials is our main concern and we take the following steps:
All clinical trials are assessed and require approval by an independent research ethics committee. The ethics committee ensures that the information we provide you is as complete as possible and that the trial is ethical.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK government regulatory authority, is responsible for clinical trial approvals where a new medicine is being developed. As part of their assessment, they check that the trial has been designed to meet safety and quality standards.
• We are an accredited Phase I unit, as part of the MHRA Phase I accreditation scheme. As part of this scheme, we are regularly inspected by the MHRA to ensure that our facilities, processes, and staff training are conducted to a high standard.
• This is a voluntary scheme for organisations conducting phase I trials, and in particular those conducting first in human (FIH) trials. As part of the scheme, we are required to have additional procedures in place to ensure the highest standards of care of clinical trial volunteers and handling of any medical emergencies.
Potential risks and side effects are investigated during pre-clinical rigorous safety assessments. However, there is always some risk associated with taking any medication and, for new medicines, there may be side effects that we don’t know. You will receive an information and consent form in advance, which has been approved by the ethics committee. This will contain the information you need, as well as expected side effects, to help you decide whether you want to take part. We provide 24/7 doctor and nurse cover for volunteers during trial activities at the unit.
All clinical trials are assessed and require approval by an independent research ethics committee. The ethics committee ensures that the information we provide you is as complete as possible and that the trial is ethical.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK government regulatory authority, is responsible for clinical trial approvals where a new medicine is being developed. As part of their assessment, they check that the trial has been designed to meet safety and quality standards.
• We are an accredited Phase I unit, as part of the MHRA Phase I accreditation scheme. As part of this scheme, we are regularly inspected by the MHRA to ensure that our facilities, processes, and staff training are conducted to a high standard.
• This is a voluntary scheme for organisations conducting phase I trials, and in particular those conducting first in human (FIH) trials. As part of the scheme, we are required to have additional procedures in place to ensure the highest standards of care of clinical trial volunteers and handling of any medical emergencies.
Potential risks and side effects are investigated during pre-clinical rigorous safety assessments. However, there is always some risk associated with taking any medication and, for new medicines, there may be side effects that we don’t know. You will receive an information and consent form in advance, which has been approved by the ethics committee. This will contain the information you need, as well as expected side effects, to help you decide whether you want to take part. We provide 24/7 doctor and nurse cover for volunteers during trial activities at the unit.
Some trials have restrictions, and some do not. For example, some trials require non-smokers. We will discuss the restrictions with you to confirm that you meet the trial requirements without changing your usual lifestyle. We cannot enrol volunteers whose usual lifestyle cannot meet the trial restrictions.
Some medicines are undetectable after a few hours, and some may take up to or longer than three months.
If you participate in more than one clinical trial, for your own safety we will ask you to leave a gap between trials. Depending on the trial, this can vary between one to three months.
You can stop participating at any time without providing a reason. We will invite you to conduct any tests that were scheduled for your final visit at the time you leave, at a withdrawal visit. It is important you attend the withdrawal visit for your own safety. There will be no further collection of samples or information after you’ve stopped participating, but we will keep the information and samples collected up to that point. If you want your samples destroyed, you can ask for them to be destroyed in writing.
We will ask your consent to keep in touch to make sure you are keeping well.
Your honorarium will be calculated pro rata considering how much of the trial you have completed.
We will ask your consent to keep in touch to make sure you are keeping well.
Your honorarium will be calculated pro rata considering how much of the trial you have completed.
• Comfortable clothing and footwear
• Toiletries
• A personal cell phone, laptop computer or tablet
• A personal video game system
• Books and magazines
For long stays there is a laundry service.
• Toiletries
• A personal cell phone, laptop computer or tablet
• A personal video game system
• Books and magazines
For long stays there is a laundry service.
Visitors are not allowed in the unit due to the privacy of other volunteers. However, you are free to contact family and friends via the phone and internet.
To ensure the ongoing safety of our clinical trial volunteers, visitors and unit staff we have a unit COVID-19 policy, which is regularly updated. The updates review government recommendations as well as how much COVID-19 is in the community. As part of the policy you may be asked about any recent symptoms of COVID-19 before you come into the unit. We may also ask you to have the following tests:
• Lateral flow testing for COVID-19 on days that you are attending the unit. We may need evidence of this (e.g. photographic), if this is done in the 24 hours before a visit.
• PCR testing before being admitted to the unit (usually three days before).
If you are being considered for a clinical trial, we may require you to have been fully vaccinated against COVID-19 (e.g. in most circumstances at least two doses of COVID-19 vaccine).
If you’re worried about COVID-19, you can get more information at: www.nhs.uk /conditions/coronavirus-covid-19/ and https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public
• Lateral flow testing for COVID-19 on days that you are attending the unit. We may need evidence of this (e.g. photographic), if this is done in the 24 hours before a visit.
• PCR testing before being admitted to the unit (usually three days before).
If you are being considered for a clinical trial, we may require you to have been fully vaccinated against COVID-19 (e.g. in most circumstances at least two doses of COVID-19 vaccine).
If you’re worried about COVID-19, you can get more information at: www.nhs.uk /conditions/coronavirus-covid-19/ and https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public
Please call 0800 3284 195 for more information or view our current clinical trials here.
Your journey as a Volunteer
We Will Be in Touch
Our Recruitment team will contact you about your application and clinical trials you may be eligible to participate in. We’d like to get to know you and make sure we have all the information we need. If we think you are eligible for any clinical trials, you will also receive a Participant Information Sheet which provides an outline and further information about the trial.
TELEPHONE PRE-SCREENING
We will ask you questions about your medical history and lifestyle to see if you may be eligible to take part in the clinical trial. You will have the opportunity to ask questions, discuss your availability and find out more about the trial.
INFORMED CONSENT
Before you decide to join a clinical trial, you will have the opportunity to talk to other people you feel comfortable with such as family, trusted friends, or your doctor about your participation. If you decide to participate, when you come into the Unit you will be asked to sign a consent form. This is called Informed Consent. By signing the Consent Form, you are agreeing to participate in the clinical trial. Our medical team will be happy to answer any questions you have about the clinical trial and give you as much time as you need before signing the consent form.
SCREENINGS TESTS & MEDICAL
While in the Unit, our medical team will undertake medical tests (e.g. blood, urine, and other trial-specific test) to determine whether you meet the criteria for the clinical trial and that it will be as safe as possible for you to participate.
Eligibility Decision & Pre-Trial Requirements
Once all your test results are in, our medical team will be in touch to confirm whether you are suitable for the clinical trial. They will also share with you any pre-trial requirements (e.g. not consuming alcohol) and confirm the logistics for your trial.
Clinical Trial Enrolment
Your enrolment into the clinical trial is typically within 28 days of your Screening appointment. Clinical trials differ in their design and therefore require different levels of time and commitment. For example, some trials just ask for a blood sample, some involve outpatient visits, and some require one or more overnight stays in our research Unit.
Clinical Trial Participation
During the clinical trial you will undergo certain trial procedures and your safety will be monitored throughout by our medical team. There are facilities and free WiFi to accommodate either remote working or relaxation when you are not occupied with trial procedures. You can find out more about our facilities below.
Step 1 of 7
Meet the Team
Our team of experts are here to support you and ensure you receive appropriate medical attention throughout your clinical trial journey.
Recruitment & Screening Teams
Our recruitment and screening teams are a combination of administrative and clinical staff, some of whom are nurses and healthcare technicians, who have great experience of recruiting and screening volunteers to our clinical trials.
Physician Team
Our physician team is responsible for the overall clinical trial. Physicians manage the day-to-day care and safety of our clinical trial volunteers.
Clinical Ward Manager Team
Our clinical ward managers are a combination of nurses and healthcare technicians who have the responsibility for your day-to-day care whilst you are on a clinical trial.
Our Clinical Research Unit
Visits will take place at our Clinical Research Unit (Clinical Unit Cambridge) within the site of Addenbrooke's Hospital in Cambridge.
During visits, you will have easy access to:
Stay Connected
• Unlimited WiFi
• 2 private pods for phone calls and working
• 2 private pods for phone calls and working
Food
All your meals during your stay are prepared by our on-site chefs, who can cater for any dietary requirements. Enjoy restaurant-standard food, cooked fresh every day.
Leisure
• Entertainment (Xbox, PS5 and a pool table)
• BT Sport and full Sky TV Package
• Comfortable areas to work and relax
• Books, newspapers, board games and DVDs
• BT Sport and full Sky TV Package
• Comfortable areas to work and relax
• Books, newspapers, board games and DVDs
Hygiene
• Laundry service (for longer stays)
• Shower facilities
• Shower facilities
Storage
Secure storage for your belongings
What are Clinical Trials?
Clinical trials are medical research performed in people. Most clinical trials investigate whether a new medicine is safe and effective for the treatment of a medical condition. Though, some may also help our understanding of disease processes.
FAQs
When we start a clinical trial, we invite volunteers who match the trial requirements (for example, healthy males and females aged 18 to 65 years) either from our panel of Clinical Trial Volunteers or those who have responded through advertising to learn more about the trial. This is usually done by email. If you are interested, we will invite you to our Clinical Unit in Cambridge to learn more about the trial at an informed consent talk.
At the informed consent talk, you will have the opportunity to have a comprehensive discussion with staff and ask any questions you may have about the trial. If your questions are answered to your satisfaction and you decide to participate, you will undergo a medical assessment and some investigations, such as blood and urine tests, as part of this process. This is to ensure that you are healthy and that it will be as safe as possible for you to participate. It also ensures that you meet the criteria of the trial. Once both these conditions are met, you will be invited to be enrolled in the trial. This is usually within 28 days of your screening visit.
At the informed consent talk, you will have the opportunity to have a comprehensive discussion with staff and ask any questions you may have about the trial. If your questions are answered to your satisfaction and you decide to participate, you will undergo a medical assessment and some investigations, such as blood and urine tests, as part of this process. This is to ensure that you are healthy and that it will be as safe as possible for you to participate. It also ensures that you meet the criteria of the trial. Once both these conditions are met, you will be invited to be enrolled in the trial. This is usually within 28 days of your screening visit.
The safety of the volunteers in our clinical trials is our main concern and we take the following steps:
All clinical trials are assessed and require approval by an independent research ethics committee. The ethics committee ensures that the information we provide you is as complete as possible and that the trial is ethical.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK government regulatory authority, is responsible for clinical trial approvals where a new medicine is being developed. As part of their assessment, they check that the trial has been designed to meet safety and quality standards.
• We are an accredited Phase I unit, as part of the MHRA Phase I accreditation scheme. As part of this scheme, we are regularly inspected by the MHRA to ensure that our facilities, processes, and staff training are conducted to a high standard.
• This is a voluntary scheme for organisations conducting phase I trials, and in particular those conducting first in human (FIH) trials. As part of the scheme, we are required to have additional procedures in place to ensure the highest standards of care of clinical trial volunteers and handling of any medical emergencies.
Potential risks and side effects are investigated during pre-clinical rigorous safety assessments. However, there is always some risk associated with taking any medication and, for new medicines, there may be side effects that we don’t know. You will receive an information and consent form in advance, which has been approved by the ethics committee. This will contain the information you need, as well as expected side effects, to help you decide whether you want to take part. We provide 24/7 doctor and nurse cover for volunteers during trial activities at the unit.
All clinical trials are assessed and require approval by an independent research ethics committee. The ethics committee ensures that the information we provide you is as complete as possible and that the trial is ethical.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK government regulatory authority, is responsible for clinical trial approvals where a new medicine is being developed. As part of their assessment, they check that the trial has been designed to meet safety and quality standards.
• We are an accredited Phase I unit, as part of the MHRA Phase I accreditation scheme. As part of this scheme, we are regularly inspected by the MHRA to ensure that our facilities, processes, and staff training are conducted to a high standard.
• This is a voluntary scheme for organisations conducting phase I trials, and in particular those conducting first in human (FIH) trials. As part of the scheme, we are required to have additional procedures in place to ensure the highest standards of care of clinical trial volunteers and handling of any medical emergencies.
Potential risks and side effects are investigated during pre-clinical rigorous safety assessments. However, there is always some risk associated with taking any medication and, for new medicines, there may be side effects that we don’t know. You will receive an information and consent form in advance, which has been approved by the ethics committee. This will contain the information you need, as well as expected side effects, to help you decide whether you want to take part. We provide 24/7 doctor and nurse cover for volunteers during trial activities at the unit.
Some trials have restrictions, and some do not. For example, some trials require non-smokers. We will discuss the restrictions with you to confirm that you meet the trial requirements without changing your usual lifestyle. We cannot enrol volunteers whose usual lifestyle cannot meet the trial restrictions.
Some medicines are undetectable after a few hours, and some may take up to or longer than three months.
If you participate in more than one clinical trial, for your own safety we will ask you to leave a gap between trials. Depending on the trial, this can vary between one to three months.
You can stop participating at any time without providing a reason. We will invite you to conduct any tests that were scheduled for your final visit at the time you leave, at a withdrawal visit. It is important you attend the withdrawal visit for your own safety. There will be no further collection of samples or information after you’ve stopped participating, but we will keep the information and samples collected up to that point. If you want your samples destroyed, you can ask for them to be destroyed in writing.
We will ask your consent to keep in touch to make sure you are keeping well.
Your honorarium will be calculated pro rata considering how much of the trial you have completed.
We will ask your consent to keep in touch to make sure you are keeping well.
Your honorarium will be calculated pro rata considering how much of the trial you have completed.
• Comfortable clothing and footwear
• Toiletries
• A personal cell phone, laptop computer or tablet
• A personal video game system
• Books and magazines
For long stays there is a laundry service.
• Toiletries
• A personal cell phone, laptop computer or tablet
• A personal video game system
• Books and magazines
For long stays there is a laundry service.
Visitors are not allowed in the unit due to the privacy of other volunteers. However, you are free to contact family and friends via the phone and internet.
To ensure the ongoing safety of our clinical trial volunteers, visitors and unit staff we have a unit COVID-19 policy, which is regularly updated. The updates review government recommendations as well as how much COVID-19 is in the community. As part of the policy you may be asked about any recent symptoms of COVID-19 before you come into the unit. We may also ask you to have the following tests:
• Lateral flow testing for COVID-19 on days that you are attending the unit. We may need evidence of this (e.g. photographic), if this is done in the 24 hours before a visit.
• PCR testing before being admitted to the unit (usually three days before).
If you are being considered for a clinical trial, we may require you to have been fully vaccinated against COVID-19 (e.g. in most circumstances at least two doses of COVID-19 vaccine).
If you’re worried about COVID-19, you can get more information at: www.nhs.uk /conditions/coronavirus-covid-19/ and https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public
• Lateral flow testing for COVID-19 on days that you are attending the unit. We may need evidence of this (e.g. photographic), if this is done in the 24 hours before a visit.
• PCR testing before being admitted to the unit (usually three days before).
If you are being considered for a clinical trial, we may require you to have been fully vaccinated against COVID-19 (e.g. in most circumstances at least two doses of COVID-19 vaccine).
If you’re worried about COVID-19, you can get more information at: www.nhs.uk /conditions/coronavirus-covid-19/ and https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public
Please call 0800 3284 195 for more information or view our current clinical trials here.
