Encyclopedia

The informed consent form (ICF) is part of the patient information. The ICF is used to document in writing that a patient agrees to the participation in a certain clinical trial after having been comprehensively informed about the trial by the investigator and after having received satisfactory answers to all their questions. The patient may…

Investigational medicinal product (IMP) generally means an active substance that is used in a clinical study. This can include both approved and non-approved substances. An official definition of the term is defined in Section 3 (3) GCP V: Investigational medicinal products are dosage forms of active substances or placebos that are tested in a human…