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Frequently Asked Questions

We are transparent with our participants about what our trials offer. We want you to
feel safe & well advised prior to taking part in a study. Find out more as we
answer our frequently asked questions.

About Clinical Trials

What is a Clinical Trial?

Clinical Trials are research studies that explore whether a medical strategy or treatment is effective or if the health claims associated with the product are accurate. The only way that this can be tested for effectiveness and tolerance is with the help of our volunteers.

What is a placebo controlled trial?

It is a clinical trial where one product is active (test product) and one is a dummy product. Participants or study staff will not know which product they receive in order to test the true effects on their own merit.

What kind of products do you work with?

We use only foods, food derivatives & food extracts for our trials.

What are the steps in taking part in a trial?

First, we ask volunteers to fill out a Pre-Screening  Questionnaire which we then review for their eligibility. You are then  contacted by one of our Recruitment Officers and if you are eligible a  Telephone Screening Questionnaire will be carried out. If you remain eligible,  the next step is to attend a visit at our clinic. Another assessment of your  eligibility is then carried out and if you remain eligible, you are given a  place on the study.

What is informed consent?

Before you begin a clinical trial, you will be asked to read a document known as the Informed Consent Form. This document contains important details about the trial that you have expressed an interest in participating in. All Volunteers are required to sign this before they can be enrolled onto a trials.

What are inclusion & exclusion criteria?

Inclusion criteria are requirements that participants must have in order to qualify for a study.
Exclusion criteria are characteristics that disqualify participants from a study.

Each trial has its own set of Inclusion & Exclusion criteria.

What is a wash out?

A washout refers to a period of time where you are asked to stop taking any foods, supplements and/or medicinal products in order to qualify you for a study.

A washout can also refer to the period between finishing one study and beginning a new one.

How long do I have to wait after completing one trial to begin another?

Generally, we recommended 60 days between finishing one trial and beginning another, this length can differ between trials however. This is known as a “washout”.

What type of samples do I need to provide?

Depending on the trial you may have to provide different types of samples, these include; Blood, saliva, stool, urine.

Who is funding the trials?

Different sponsors (food-based companies) from around the world come to Atlantia and request us to conduct a trial on their behalf.

Benefits

Why participate?

Free health check – At visits we accurately measure your BMI , Blood Pressure & perform blood analysis so we can inform you on health markers such as cholesterol. The blood draw is performed by one of our research nurses or trained phlebotomists. Some trials also have added benefits such as free x-rays, DXA scans or MRI scans.

Compensation – We value our participants, therefore adequate financial compensation is given to each of our participants for their contribution. This figure varies across our studies.

Contributing to the advancement of science – Without trials it would not be possible for companies to show if foods have any beneficial effect on health. So, by taking part in trials you are enabling these companies to create new health products which can benefit everyone.

Do I get compensated for participating?

Yes, all our participants are reimbursed for the time on the study. Each studies payment amount differs. The payment method given is in the form of a cheque.

Participation

What about participant safety?

All trials are approved by our local ethics committee which is a rigorous process. This committee is made up of consultants, regulatory specialists, nurses & the general public.

The majority of our trials use products which have no known risks or side effects. If there are any known risk associated with product they are clearly stated in the informed consent which is given to you prior to the beginning of your first visit to our clinic.

All our staff are trained to conduct research trials according to ICH-GCP standards which ensure each participant is treated in the appropriate manner and a strict set of procedures is followed.

I am participating in a study, can I leave?

You can leave at any time during a study, please note however, you may not receive any reimbursement fee.

Eligibility

Who is eligible to participate in a trial?

We require people that are generally healthy for studies, but we often have trials aimed at people with certain conditions such as high cholesterol, asthma, indigestion and high blood pressure.

General

I filled out the pre-screening questionnaire but heard nothing back?

Due to the level of interest in trials, it can take some time to get in contact with everyone that has applied, so please be patient with us. If you are particularly interested in a trial, you can get in contact with us directly by phone or email and we will be happy to help.

Is my data confidential?

Yes, all your information is protected according to GDPR standards.

How do I get removed from your database?

If you wish to not be contacted by us in the future, please contact dataprotectionofficer@atlantiatrials.com with your request.