Informed consent is one of the most crucial processes in the clinical trials. Well performed informed consent process ensures that the subject’s rights and well-being is protected. Following unethical experiments performed in the past which are now black cards of the clinical trials history, several guidelines were developed f.e. Declaration of Helsinki which strongly underline that subject can be enrolled into the study only after the informed consent is given. This is also reflected in the ICH GCP and local regulations. This course provides general overview on informed consent process and form and explains what the difference between those 2 terms is. Course covers also requirements towards the Inform Consent Form (ICF), documentation of the consent process, parties involved in this process and regulations and guidelines. During the course, participant will be provided with real examples of informed consent forms to better understand how to work with this document and how to verify the consent process. Course is followed by bank of questions and case study exercise so the participant can verify the knowledge.