FAQ

General

Should I expect side effects of the new medicine during the study?

We cannot predict side effects before they happen. Based on previous studies, doctors can make a judgement as to what side effects may occur. This will be discussed during the screening. In any event, your health will always be closely monitored and queried by our medical team.   

What is Verified Clinical Trials (VCT) and can I refuse this?

For safety reasons, you can always only take part in 1 clinical study at the same time. VCT is used to check this. The interval between consecutive studies also needs to be respected.  You cannot take part in our research centre without agreeing to VCT. 

What happens if I get ill during the study?

If you feel unwell during or after your stay, you should let the medical personnel know immediately. A decision will be made in consultation with a doctor to determine whether you can continue in the study. 

Can I (still) donate blood and/or plasma while I take part?

You cannot donate blood and/or plasma during your participation in a clinical study to investigate a new medicine. Study medicine will be administered to you which will be absorbed in your blood. If you donated blood, this medicine could end up in the bloodstream of the person receiving your blood. That would of course not be acceptable for safety reasons.  

What are the inclusion criteria applicable to participation in a specific study?

All the inclusion criteria are listed in the information sheet for the study. We will also check your profile before scheduling an appointment for the screening.

Can I bring my mobile, laptop and/or tablet?

Of course. There is free WiFi available throughout the research centre. You will have a personal locker available to you for secure storage of all your devices. 

Can I withdraw from a clinical study?

Taking part in a clinical study to investigate a new medicine is always without any obligation and is completely voluntary. You can decide to withdraw from the study at any time by talking to the doctor. This means that your payment will be adjusted to your involvement in the study.

What are the relaxation options during my stay?

You can occupy yourself with whatever you like in your room. Some people might like watching TV programmes or films and others might like to read or do some crafting. Gaming, studying and working are of course also possible using your own personal electronic devices. On your own or with others, whatever you like. There are communal relaxation spaces where there are board games to play and various magazines available to read. There is even a pool table and a sunny patio.  

Do I have to stay overnight at the research centre?

The information sheet of the specific trial clearly states whether you need to stay overnight. This is usually the case, and this cannot be changed.    

Why do you need to test on healthy volunteers and not on patients?

There are various phases in the development of new medicines. After years of laboratory testing, the medicine undergoes first-in-human testing. These early-phase studies are conducted to investigate the body's response and any side effects in healthy volunteers. That ensures that the entire study can be conducted under set conditions and allows appropriate conclusions to be drawn. Only after extensive testing will it be used in patients to get a clear understanding of the efficacy.  

Are there any rules I need to follow during my stay?

The house rules will be discussed in detail during the screening.  Cigarettes, alcohol and caffeine are excluded in most studies. 

How will the study medicine be administered?

This depends very much on the type of study you take part in. You will be informed in detail during the screening. The most common routes of administration are: oral (by mouth as a solution or tablet), intravenous (via a vein), subcutaneous (under the skin) or intramuscular (via a muscle). 

Can I give feedback about my experiences at the research centre?

We value any feedback you can give us about your experiences at our research centre. Complete this questionnaire to give your feedback (fully anonymously). You can of course also phone or email us.  

Can I bring my own food and drink?

You cannot bring your own food and drink when you come and stay at the research centre. All meals, snacks and drinks are provided as all candidates need to consume the same food, often at set times.  

Will I have spare time during my stay at the research centre?

Yes you will! The only busy days for you as a volunteer are the days the study medicine is administered. You will be continuously monitored very closely at those times. You have will plenty of spare time on the other days of the study and you can use our relaxation spaces and options. 

Can I work during my stay?

If your employer has approved this, all the facilities to allow you to combine your stay with work are available. Just bring your laptop/tablet and we provide the WiFi.  Make sure you do not disturb other pioneers and that you are aware that there are certain days with tests scheduled at strict times that cannot be changed. 

Can I take part if I'm a vegetarian?

We can provide vegetarian meals for certain studies.  

Are there any incentives for introducing new pioneers?

Yes there are! We want to thank you for introducing new pioneers. More information is available here

What are kinetics?

The study medicine is administered on kinetics days. Kinetics days are busy days with lots of actions and tests to monitor your body's response to the medicine.  

What does the research centre look like?

Click here to see what our facility looks like.

How often can I take part?

You can take part as often as you like. Most trials require an interval of at least 30 days before you can start a new study. Longer intervals may sometimes be required. This depends on the study medicine and is determined by the time needed for all of the medicine to leave your body completely.

Can I have visitors during my stay?

Visitors are currently not allowed because of the COVID-19 pandemic. 

How can I enrol for a specific study?

The information sheet for the specific study tells you how to contact us to register your interest. If you're not registered in our database yet, we will contact you to get to know you better and to be able to request your medical data. That allows us to decide whether you are eligible. If you are already registered in our database, your registration for the study is complete and we will include you in the selection procedure. How exactly that process works is described here

How often will blood samples be taken?

The first blood sample will be taken during the screening to check whether your blood test results allow you to take part in a study. We will then take a blood sample a few days or hours before the administration of the study medicine so we have a baseline value. After the medicine has been dosed, blood will be drawn various times to look at the way the concentration of the medicine evolves in your blood.  

Can I choose my own room type?

There are various types of rooms at our research centre. They range from single rooms to 8-people rooms. Unfortunately, it's not possible to register your preference. The type of trial and operational occupancy will determine your room type.   

Screening

Where does the screening take place?

The screening takes place at the SGS CPU research centre in Edegem: Drie Eikenstraat 655, 2650 Edegem (UZA campus - Building J). 

Why do I need to sign a consent form?

By signing the consent form, you formally confirm that you have carefully considered taking part in the study and that all the information was clear and that you are willing to take part. This procedure is required by law. Without your official consent, you cannot start in the study. 

How and when will I find out whether I have been selected to continue in the main clinical study?

The medical team will carefully review your medical profile, including results of the screening, in the week to 10 days after your screening. We will then contact you to let you know our decision.  

What happens during the screening?

During the screening, you will receive extensive information about the specific study. You can also ask the medical team any questions you have. Once everything is clear for you and you agree to take part further, you and the doctor will sign the consent form. From then on, you will be part of the study and we will investigate in detail whether you are eligible to take part in the next steps. The screening involves a consultation with a doctor and a few medical tests. This will include checks of your blood pressure, weight and urine. 

Directions

Is the research centre easy to reach by car?

Absolutely. All detailed information is available here

Is the research centre accessible by public transport?

The research centre is easy to reach by train, bus and bike share programmes. The detailed information is available here.   

Where can I park?

You can use the visitors car park at the UZA free of charge. More information is available here.  

During my stay

Is there a washing machine available during my stay?

A washing machine and tumble dryer are available in every unit. Talk to the study personnel if you want to use them.

Are the rooms mixed?

Yes. A room will be assigned to you by order of enrolment in the study. This means that there may be someone of the opposite sex in the bed next to you.

What do I need to bring with me?

You need to bring your own clothes and towels. 

Compensation

What payment will I receive for the clinical study?

The payment for taking part is specific to each study and correlates to the time pioneers need to invest. The amount is always clearly stated in the information sheet for the study. More general information about the payment is available here.  

Does more compensation mean there are greater risks?

No. The payment compensates you for your involvement as a pioneer and is not a reflection of the health risks. More general information about the payment is available here

Whom can I contact with questions about my payment?

If you have any questions about your payment, contact us e.g. using this contact form. We are here to help you.  

When will the payment be made?

The payment time depends on the stage in the study. If you take part in the screening, but do not end up taking part in the study, the payment will be initiated after the first time the medicine has been administered. If you take part in the study itself, the payment will be made after the final examination. You will receive the payment no longer than 6 weeks after it has been initiated. 

Is the payment taxed?

The payment is only not taxed in Belgium. 

COVID-19

What happens if I have COVID-19?

If you test positive, you can unfortunately not take part in an ongoing study until you have fully recovered. You can only get a valid recovery certificate if you have an official PCR test.

Are you testing for COVID-19?

Yes, at the moment we are still testing for COVID-19. 

Any other questions?

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