Participation in a clinical trial is only possible if the person meets the specific conditions of that investigation.
Participation is voluntary and must be based on a thorough knowledge of the project that will include among others: the objectives, the tests to be performed, the drugs that are going to be provided and the potential risks that participating in the study may include. The patient must also be informed of the treatment alternatives. The agreement to participate in the study is made in writing by signing a document called an informed consent form. If a patient is unable to give consent (minors and incapacitated adults), their legal representative may do so.
The participants are entitled to receive a copy of the Subject Information Sheet and should be given details of whom to contact if questions or problems arise while participating in the study.