What are the rights and duties of trial participants?

Which rights do I have as trial participant?

1. All participants must be informed in detail about the planned trial and must give their consent.
2. You will receive a copy of the patient informed consent form which must be signed by you and your study doctor.
3. You have access to insurance conditions.
4. If you have any questions or concerns, you can contact your study doctor at any time.
5. You can withdraw from participating in this trial at any time without giving any reasons. This will not affect your further medical treatment in any way.

Which duties do I have as trial participant?

1. You must keep all scheduled appointments.
2. You must inform your general practitioner about your participation in the trial.
3. You must follow your study doctor’s instructions.
4. You must notify your study doctor if you are taking additional medication, e.g. if you have complaints.
5. You must notify your study doctor if you have changed your address or general practitioner.
6. If you experience any adverse reactions to the trial medication, you must contact the trial site immediately.