Encyclopedia

In accordance with § 3 sec. 2b GCP Ordinance, the investigator must conduct an informed consent discussion informing the patient comprehensively about the content of the trial, its benefit, risks and treatment alternatives before they may be enrolled in a clinical trial. Furthermore, the patient will receive the patient information which is written in a…

The term pharmacovigilance refers to all measures related to the ongoing and systematic monitoring of the safety of medicinal products. On the one hand, pharmacovigilance activities are carried out during the development phase of a new drug within the context of clinical trials, but also following market authorization in order to identify and prevent risks…

The investigator is responsible for conducting a clinical trial at their study site. In case several investigators are involved in conducting a trial at a single study site, a so called principal investigator (PI) must be appointed and all other investigators are referred to as subinvestigators in ICH‑GCP 1.56. The German Medicinal Products Act does…

Prospective is used to describe something that is relating to the future. The objective of a prospective trial is defined before its start. The data needed to answer a specific scientific question will then be collected especially for this trial. All interventional clinical trials are prospective trials. One example of a prospective non-interventional trial is…

The trial protocol, also known as the study protocol or the test protocol, is the basis of every clinical trial. In includes detailed information on the conduct of the study. ICH-GCP section 6 lists the obligatory contents of a trial protocol. Some of the most essential elements are listed here: information on the sponsor, investigators,…