Subject

Trial subjects, human subjects, participants and volunteers are synonyms for people who volunteer to take part in clinical studies (sometimes derogatorily referred to as guinea pigs). The clinical trials can include a variety of studies such as drug, medical, psychological and nutritional research. Test subjects can also be required for testing (medical) equipment. The ultimate goal is, with the help of test subjects, to develop (better) drugs or obtain better insights for improving products or processes.

How can I participate in a clinical trial?

When you register for participation on our website, you can apply for all studies, that you find interesting and that suit your specific details.

When you register for a specific study, we will review your profile to confirm you meet the initial requirements. Please note that we cannot always include all requirements that need to be met to participate in the study on our website. It is therefore possible that our initial review will conclude that you are not suitable for the study, even if you meet all the criteria listed on our website.

When you are registered for the study or if an investigator would like you to participate, the investigator will invite you for an introductory interview. During this interview the investigator will extensively inform you about the study and will answer your questions as best as possible. Together you will decide whether the study is appropriate for you. If the study seems to be a good fit and you are still interested in doing the study the next step is to confirm your consent in writing. Subsequently the study can be started. The requirements of the study, depend on what is outlined in the study protocol.

What am I expected to do during the study?

During your participation in the study, you are expected to follow the study protocol and what the physician/investigator asks of you in relation to the protocol or your safety. The study protocol outlines how often you should visit the medical center for examination, how often you should take your medication and which assessments should be done in the medical center. The protocol, and in particular the schedule of assessments, is designed to safeguard your health. The medicine or product that is being tested has to be used, according to the prescription given by the physician/investigator.

Do I receive an allowance?

As a healthy volunteer? There is a possibility that you receive an allowance for your participation. The level of the allowance depends on the type of study and the associated burden. For instance, the allowance would be higher if you are required to stay in a medical center for a couple of nights or in case you are asked to give frequent blood samples. 

As a patient? If you are a not a healthy volunteer (patient) and participating in a study, you are legally not allowed to receive a fee for your participation. You may be considered a patient, even if you feel healthy. Patients also include for instance, volunteers with high risk factors, such as heart/vascular disorder or a too high level of cholesterol. There is a possibility that you will receive an allowance for expenses made.

Who determines the allowance?

Link2Trials does not determine the (expense) allowances available for the studies. The allowance is determined by the investigator, who runs the study. This can be a pharmaceutical company, a university or another type of investigating center.

Informed Consent Procedure

Most importantly, you should be fully informed, both written and verbally by the investigator, in a way that you can clearly understand, regarding the study and what is expected from you during the study. After you have received sufficient time, you will be asked to confirm in writing that you fully understand the study, including the requirements and risks. The investigator should be present when you sign the consent form and sign it immediately after you.

You can withdraw at any moment from a study you registered for, a study in which you are already participating or remove your registration at Link2Trials, without any consequences. Your written permission is on a completely voluntary basis. You can withdraw from a study at any time, without explanation or consequences for your further treatment. 

Each study has in- and exclusion criteria. These criteria determine whether you may or may not participate in a study. If the in- and exclusion criteria match your profile, you are possibly a candidate to participate in a study. Link2Trials is not involved in agreements made, between a volunteer and an investigator and or the investigating sponsor.

Link2Trials proposes studies for you to participate in and informs the investigator/sponsor where possible candidates can be found. The investigator/sponsor pays Link2Trials a fee for expenses made by Link2Trials. The investigator/sponsor will contact you and will arrange everything for you and will decide whether you may participate in a study. Link2Trials does interfere in this process.

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