Patient consent form

Prior to voluntary participation in a clinical trial, the trial participant (patient or test person) must submit a written patient consent form or an Informed Consent Form (ICF) according to § 40 AMG, § 20 MPG, § 3 (2b) of the GCP regulation and the Declaration of Helsinki.

The trial participant has the right to receive detailed information (patient information) and must have sufficient time to consider the matter before signing the patient consent and starting the clinical trial. Before signing the patient consent form for participation in the study, the investigator must therefore discuss the patient information in a personal educational interview and answer questions from the study participant.

The patient information is regulated by GCP - just like the patient consent - and must be comprehensible, explain the content and the course of the study, contain information about the drug or medical device, inform about the rights and obligations of all parties involved and about possible advantages and disadvantages as well as risks and side effects of the study.

The clarification and obtaining of the signature may only be obtained from licensed physicians. The date and signature on the patient consent form must be provided by the investigator and the trial participant themselves - the physician may also not prescribe the date. The patient information leaflet must also contain information on data protection, any patient insurance policies / trial participant insurance taken out and the right to withdraw consent.

The patient information or declarations of consent must be evaluated and approved by the ethics committee. To ensure that the documents meet the requirements, they are usually prepared by a Clinical Research Organisation (CRO) in consultation with the sponsor.

In exceptional cases, the clinical trial can also be conducted with study participants who are not able to give consent, if the declaration of consent is signed by the legal representative (§ 41 AMG, § 21 MPG, § 3 GCP regulation).