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Taking part in a study

How does a clinical study actually work? It is important to us that you receive answers to all the questions that matter to you before you take part in a clinical study. That is why every participation is preceded by several conversations with you.

Clinical trials unit of the Diabetes Centre Dortmund

1. Adding your details to our database

First, your personal details are recorded electronically during a telephone call. In addition to information on your age and contact details, medical data on medication, illnesses etc. is then also entered into our database. Following this call you will receive a data protection letter from us. If you do not consent in writing within ten days to the data storage explained once more in that letter, your personal data will automatically be deleted from our system. It is important to know that at this point there is not necessarily a study that suits you. Inclusion in the database is therefore always the first step, and it may take some time before you take part in a study.

2. First contact about a specific study

The requirements for taking part vary greatly from study to study. Each study has defined inclusion and exclusion criteria that must match your profile before you can take part in the study. If you are eligible to take part in a specific clinical study, we will contact you and present it to you. Where possible, we will also arrange all study appointments with you in advance, so that you can plan your participation in your private life as well.

3. The medical information consultation

Before the study activities begin, a study doctor will inform you about the trial procedure and the investigational products or devices used, in a detailed medical information consultation at our trials unit. In this consultation you have the opportunity to discuss all open questions in person and in confidence. The doctor will also explain which side effects may occur. You will also receive all information about the study in writing in the form of an information brochure. If you decide that you would like to take part in the study, your written consent will then be required on site. As a rule, a clinical study then runs in three phases: the screening phase, the treatment phase and the final phase.

4. The screening examination

In a thorough screening examination, your suitability for taking part in the clinical study is first checked by comparing specific requirements with your profile.

5. The treatment phase

The treatment phase of every clinical study begins with a further physical examination and a check of the inclusion and exclusion criteria, in which your suitability for taking part in the study must be confirmed again. The clinical trial that follows varies greatly from study to study: for example, appointments may be inpatient or outpatient, and the total duration of the clinical trial and the number of applications of the product under investigation vary according to the study schedule.

6. The final examination

At the final examination, a comprehensive physical examination is carried out one last time, various other data is collected and samples are taken. After that, the study participation is complete for the participant.

For your own safety, after taking part in a study you may not be enrolled in another study for a certain period (depending on the study-specific inclusion and exclusion criteria). Once this exclusion period has ended, we would be delighted if you would like to take part in a study again.

Taking part

Interested in taking part in a study?

We will inform you without obligation about ongoing studies and check together with you whether taking part is an option.

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