The same regulatory requirements (AMG/MPG) and Guidelines of Good Clinical Practice (ICH-GCP or ISO14155) are applied for Investigator Initiiated Trials (IIT), as in studies initiated by industry. Within the scope of an IIT, investigators or hospitals take over the sponsor’s responsibilities and are therefore responsible to guarantee the patient‘s rights and safety, as well as the achievement of high quality data and integrity.

You may find the most important tasks of the (Investigator-)sponsor on the next pages, divided into three study phases study planning, study conduct and study close-out. A questionnaire is offered additionally, where you can test, if you have the resources and the knowledge on hand to take over Sponsor’s responsibilities.