Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
WHO CAN PARTICIPATE IN THIS TRIAL?
Note:
WHAT IS THE COMPENSATION FOR THIS RESEARCH
You will receive a gross compensation of € 6393 for participation in the trial. In case you have to return for one or more 24-hour visits, you will receive a gross compensation of € 263 per 24-hour visit.
Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.
HOW LONG DOES THIS RESEARCH TAKE
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 23 days (22 nights). Depending on the amount of radioactivity that has left your body after 23 days, you may have to return for at most two 24-hour visits (1 night). The follow-up visit will take place 7 – 9 days after your last departure from the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
We are not studying whether there are side effects. Therefore it is not necessary to administer a high dose, reducing the chance of side effects.
During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.
During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.
Clinical trials with drugs that are radioactively labeled is mandatory before a new medicine can be registered, and is therefore generally accepted. Radioactively labeling or marking a drug is done to be able to study how quickly and to what extent the drug to be studied is absorbed, converted and excreted in the body.
During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.
Read more at www.iconclinicaltrials.com/radioactivity.
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous. Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
We pay the compensation for your participation, including travel expenses, within 30 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.