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Johnson & Johnson Clinical Pharmacology Unit (CPU)
Lange Bremstraat 70
2170 Merksem, Antwerp
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General
How often can I participate in a study?
You can participate as often as you wish. Usually, a period of at least 1 month after a previous follow-up is required before starting another study. Sometimes the interval is longer, as we follow the study protocol. The duration of how long the medication remains in your body after dosing is also a determining factor (half-life). You can read the specific requirements for each study in the recruitment letter. Our staff is happy to assist you in checking which studies you are eligible for, through a verification in Verified Clinical Trials (VCT). This software program prevents rapid re-enrollment and is primarily for your own safety.
Will I receive a medical certificate for my employer if I participate in studies?
No, we do not provide absence certificates or medical notes. We can provide you with an attendance certificate; however, please note that this is not a valid absence certificate and your employer may not accept it.
Where can I securely park my bicycle or scooter?
Please place your vehicle in the designated racks near the entrance of our main building. Always keep emergency and fire exits clear. During an extended stay, it is possible to park your bicycle, scooter, or motorcycle in the hospital's secured staff parking. Please inform the reception, and we will gladly assist you in opening the access gate.
Is the research center accessible by public transport?
Yes, we are easily accessible by tram, bus, and shared cars or bikes.
Do I receive a reward if I refer friends, family, or acquaintances as volunteers?
Yes! Do you know someone who is also interested in drug research at J&J CPU? Do you have a friend, classmate, family member, or know a suitable volunteer? Refer them and you can earn a reward of € 150.
I have a compliment, complaint, or comment for J&J CPU.
We value our volunteers’ feedback. Make your voice heard in the surveys you receive after screening and during your stay. We also appreciate your feedback via email at [email protected] or by phone during office hours at 0800 97 886 (BE) or +32 3 640 32 30 (NL).
What is Verified Clinical Trials (VCT)?
VCT is an international database that research centers use to determine whether a volunteer can participate in a study. For safety reasons, you can only be dosed in one study at a time. Additionally, VCT checks the duration between consecutive studies. Without your (previous) consent (at screening), we cannot conduct a check in VCT, and you cannot participate in our studies. It is in your own interest to follow these rules.
Why is medication tested on healthy volunteers and not on patients?
The development of a new drug begins primarily in laboratories during the pre-clinical research phase. If these results are promising, the first phase of drug research follows. Once the clinical phase begins, doctors from J&J CPU will administer the study medication in low doses to healthy participants. The focus is always on safety: we investigate the tolerance of the drug, side effects, how the molecules distribute in the human body, etc.
Drugs in development are tested on both healthy individuals and patients. When a drug is first tested on humans, the preference is to test it on healthy volunteers first. One of the main reasons for this is that healthy individuals tend to have a higher tolerance for potential side effects. Additionally, we can be more certain that all organ systems are functioning normally, thus minimizing any variables that could affect the processing of the test drug.
Where can I park?
You can park in the paid parking area in front of ZNA Jan Palfijn or in the streets surrounding the hospital. After parking, you can easily walk to Janssen CPU. To do so, take the path next to the emergency department (to the right of the main entrance) to the back of the hospital.
The streets around ZNA Jan Palfijn in Merksem are in a pink parking zone. This means that parking on the streets surrounding the hospital is paid from 9 AM to 7 PM and free on Sundays and public holidays. You can park once daily for free for a maximum of 2 hours.
Due to the ZAS construction work, we will be inconvenienced in terms of parking in the coming years. We recommend coming by bike or public transport if possible. You can also park at the P+R of Merksem, only 10 minutes walking distance, for € 1 per day, + € 3 per additional day.
How do I find the department?
Do not enter the ZNA Jan Palfijn hospital; instead, follow the path to the right of the emergency department to the back and follow the signs for "Johnson & Johnson Clinical Pharmacology Unit”.
Our department consists of the main building "Merksem 1" for multi-day stays and a temporary outbuilding "Merksem 2" for screening and outpatient visits.
What is Phase 1 Clinical Research?
During Phase 1 research, the safety, and if possible, the efficacy of a molecule are tested on a group of healthy volunteers.
Is participation in clinical research safe?
In Belgium, strict national and international regulations apply to drug research on humans. A clinical study can only commence after approval from an ethics committee and Federal Agency for Medicines and Health Products (FAMHP). During the research, doctors and nurses closely monitor the volunteers, measuring and tracking safety parameters at various time points. Our primary concerns are the safety, privacy, and well-being of the volunteers. Although the risk of accidents is considered very low, it cannot be completely ruled out.
Is participation in a clinical study without risk?
No treatment is free of risk. Even registered medications (drugs already on the market) have their side effects. The study physician is required to inform potential participants about all known possible risks and side effects. These risks are also extensively outlined in the consent form that the volunteer receives and must sign. One of the goals of clinical research is, of course, to map out the side effects on humans.
Can I apply for a position? Where can I find the open vacancies?
To conduct our clinical studies, J&J CPU is often looking for new employees for various jobs. Additionally, our company also offers internships.
Can J&J employees and their family members also participate in clinical research?
J&J employees and their immediate family members cannot participate in clinical studies conducted by J&J due to privacy reasons, data integrity, and ethical considerations.
Est-ce que je peux participer à des études cliniques au CPU J&J si je parle le français?
Pour des raisons de sécurité, nous demandons que les volontaires maîtrisent le néerlandais ou l' anglais. Si vous parlez et comprenez bien le néerlandais ou l' anglais, nous pouvons vous enregistrer dans notre base de données.
Registration and your profile on cpu.be
Can I receive the registration forms by mail?
Yes, send us an email at [email protected] or call us during office hours at 0800 97 886 (BE) or +32 3 640 32 30 (NL). Provide your address details, and we will send you a package by mail.
How do I delete my account? Can I unsubscribe from the database?
We handle your request in accordance with current GDPR guidelines and regulations. Unfortunately, it is not possible to close your account through our website. You can unsubscribe easily by sending an email to [email protected] with your personal information.
How do I sign up as a volunteer?
Create an account and register yourself as a subject at J&J CPU. Fill in your personal details accurately and answer the medical questionnaire. This way, you will be added to our database of test subjects and we will keep you informed about new studies that fit your profile.
I forgot my password. What now?
Click on 'sign in' at the top of the page. Enter your email address and press sign in. If your email address is recognized by us, a new page will open. Confirm your email address once again. On the next page, click on 'Forgot Password' at the bottom and follow the instructions.
How can I sign up for a study?
Have you seen a study you would like to participate in? Great! Once you are registered on our website, you can easily sign up for the study. Always read the study conditions thoroughly and check your calendar to see if you are available for the specified periods. Your registration is non-binding and shows your interest in a study. You can also sign up for a study by phone or at our reception. After your registration, an employee will contact you by phone to review the conditions and schedule an appointment for a screening together.
How do I update my information on the website?
Once you are logged in, you can easily update your personal information via 'my CPU'. It is not possible to change your medical data or IBAN online; please report any changes during your next visit to our reception.
Screening
How long does the screening take?
The screening will last about 3 hours. Tip: make sure to set aside enough time in your schedule.
I did not receive an email after the screening with a link to the consent forms.
We apologize for this. Please send an email to [email protected], and we will provide you with a new link.
When and how will I learn the results of the selection process for participation in the study?
On average, you can expect a phone call with the results of the screening within 5 working days. If you are approved, you will be informed whether you have been selected as an effective participant, a reserve, or standby. More information can be found on the study pages. Sometimes it may take longer for all results to be known, depending on the protocol. Exceptions will be communicated during screening.
Can I request the screening results?
Yes, upon request, we will send the results by mail. If you are not approved, we will contact you and inform you of the reason.
What happens during the screening?
During the pre-examination, you will review the consent forms with the doctor. These contain complete information about the study, the schedule, possible risks, pros and cons, the compensation you will receive, etc. Only when everything is clear to you will you and the doctor sign the documents. We will also check if you meet the protocol requirements of the study, followed by medical examinations, such as taking blood pressure, a urine test, weight, etc.
Stay
Can I stay in your facility the day before my arrival?
No, unfortunately, this is not logistically feasible. Please inquire about hotels and B&Bs in the nearby area.
What are the arrival and departure times?
The schedules vary by study and can differ. Typically, arrival takes place in the early morning, and discharge is usually after lunch.
What rules apply during my participation?
Upon arrival, you will receive a tour and sign the living and behavioral guidelines with an employee. These guidelines are based on mutual respect and contain fundamental agreements.
Can I receive visitors?
No, it is not possible to receive visitors during your stay. With our free Wi-Fi, you can stay connected to the outside world.
Am I allowed to bring my own food and drinks?
No. We provide drinks, snacks, fruit, and meals. We rely on a catering company that delivers fresh dishes daily, tailored to the study protocols.
I forgot something during my stay. What now?
Please let us know as soon as possible. If we have found or taken your item into custody, you can pick it up within 3 months after your participation.
Can I choose to receive only a placebo (dummy medication)?
A placebo pill contains no active ingredient. Our results must be as reliable as possible. Who receives which treatment is determined by chance. As a volunteer, you cannot choose; this process is called randomization and is very important in our double-blind studies where placebos are used.
How will I stay at J&J CPU?
You will be assigned a bed in a mixed dormitory. Our rooms are comfortable, accommodate a maximum of 6 beds, and have a separate toilet and bathroom with a shower. Each bed can be closed off with curtains for privacy and is equipped with technical measuring equipment. Additionally, each volunteer has their own wardrobe and nightstand with a safe.
Can side effects during the study be predicted?
Not all side effects of a medication can be predicted in advance, which is one of the main reasons we conduct clinical research. However, based on previous studies, doctors can estimate which side effects may occur. Known side effects are also described in the consent form. During the study, doctors and nurses closely monitor the volunteers.
Can I participate if I follow a special diet (vegetarian, halal, etc.)?
If you do not eat (pork) meat, we always have a vegetarian alternative, unless the protocol specifies otherwise. All information about meal restrictions can be found on our study pages. Please note: certain clinical studies require a standardized meal plan, and as a volunteer, you do not have the freedom to choose. We will always inform you about this during screening.
Can I withdraw from the study if I am not comfortable?
You can decide to stop participating in the research at any time. You are not even required to provide a reason. For safety reasons, sometimes an additional visit may be scheduled after you withdraw from the study. Your compensation will be determined based on the duration of your participation. Only if the study doctor removes you for medical reasons will you still be entitled to full compensation.
Can I choose what I eat during my stay in the CPU?
No. During a study, all volunteers receive the same standardized meals for the duration of their stay in the unit. There are also additional restrictions on what you can eat and drink. For instance, you will not be served caffeinated beverages, chocolate, or citrus fruits, as these may affect the study results or jeopardize your safety.
What should I pack in my suitcase?
Bring enough comfortable clothing and toiletries. To help yourself relax, we recommend bringing sufficient materials to fill your leisure time (e.g., a book, laptop, drawing supplies, etc.). We provide bedding, towels, and shower gel/shampoo. Additionally, we offer relaxation activities to make your stay as pleasant as possible.
Compensation
The higher the compensation, the higher the risk?
In exchange for your contribution to drug development, you will receive compensation. The amount is determined based on the duration of the study and the number of outpatient visits. In no case are risks or possible side effects of the study medication taken into account; it is solely compensation for your time and commitment.
When will the compensation be paid?
Payment for standby participants, reserves, and those not selected after screening will begin after the dosing day of the study cohort. Payment for effective participants will start after the final follow-up. We maintain a payment period of approximately 6 to 8 weeks.
Can I submit parking tickets, fuel costs, or public transport receipts?
No. We provide a kilometer reimbursement that covers these costs.
Is the compensation taxable?
In principle, compensation in Belgium has not been taxable to date. Each volunteer is responsible for informing the tax authorities. J&J CPU does not provide tax certificates, even for volunteers from the Netherlands.
I have not received compensation. What should I do?
We do not pay compensation if you test positive for drugs or alcohol during the screening. The physician will inform you about this. If you are expecting compensation and have not yet received payment, it is likely still being processed; we have a payment period of approximately 6 to 8 weeks. You will receive compensation from our headquarters, J.C. General Services (and not from J&J CPU). We are happy to assist you further via email at [email protected] or by phone during office hours at 0800 97 886 (BE) or +32 3 640 32 30 (NL).
What will I be paid for participating in the study?
The amount is determined based on the duration of the study and the number of outpatient visits. In no case are risks or possible side effects of the study medication taken into account; it is solely compensation for your time and commitment. Additionally, you will receive a kilometer reimbursement for each visit, set at €0.4246 per kilometer. We reimburse a minimum of 24 kilometers to a maximum of 100 kilometers for a one-way trip.