Encyclopedia

The National Association of Statutory Health Insurance Physicians, also known by the acronym KBV (German – Kassenärztliche Bundesvereinigung), was founded in 1955 and its headquarters are located in Berlin. Its regulatory authority is the German Federal Ministry of Health. The KBV represents the interests of doctor and psychotherapists on the federal level and presents their…

Observational studies are non-interventional studies. Usually they are conducted by pharmaceutical manufacturers for their approved medicinal products. During the course of an observational study data of a large number of patients is collected and evaluated, for example data concerning the use by the patient. An observational study is a good way to evaluate the treatment…

In clinical trials, one differentiates between certain kinds of monitoring: On-site monitoring, remote monitoring, and risk-based monitoring. The most frequently conducted kind is on-site monitoring. For that, the Clinical Research Associate (CRA) needs to be present at the study site. By means of source data verification (SDV) and revision of the investigator site file (ISF),…

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,…

The process of randomly assigning study participants to different treatment arms in a clinical trial is called randomization. In order to avoid a potential bias, the allocation is not performed by an investigator or a sponsor’s representative. An investigator who is convinced of the investigational drug’s effectiveness might (possibly unintentionally) assign certain patients to the…

The goal of a registry is to enroll the highest possible number of patients in order to collect data. Patients who have a common attribute – e.g. are suffering from the same disease or receiving the same certain treatment – can become part of the registry. If the patients agree to participate, they give their…

Regulatory Affairs include all activities that predominantly deal with the regulations in the area of research, approval or marketing authorization. In pharmaceutical research, the Regulatory Affairs sector includes the application for approval / a positive opinion regarding the conduct of a clinical trial, the subsequent steps such as the reply to deficiency letters, notification of…

Among other important tasks, during a monitoring visit the clinical research associate will perform source data verification, meaning a review of all source data. Depending on the provisions set out in the monitoring manual, this may be partial or complete (100% SDV) verification. The CRA will then verify the data collected in the CRF against…

According to ICH-GCP, the sponsor is any natural person or corporate entity that is responsible for the funding and the conduct of a clinical trial. ISO-14155 states that the sponsor is an individual or organization taking responsibility and liability for the initiation or implementation of a clinical investigation. According to both ICH-GCP and ISO-14155, an…

The site where a study/trial is being conducted. These sites can be hospital wards, medical practices or other institutions that are selected for the conduct of a clinical trial. Involved departments, such as pharmacies, radiology, cardiology etc. can be affiliated to the study site and conduct examinations within the framework of a trial. The principal…

Before a clinical trial can be conducted, it has to be approved by the higher federal authority and granted a favorable decision by the responsible ethics committee. During a written application by the sponsor in Germany, the following documents need to be submitted in German and English language, in accordance with § 7 Par. 2…

The Trial Master File (TMF) is one of the main files (in addition to the Investigator Site File, ISF) in which all essential clinical trial documents must be stored. ICH-GCP section 8 lists which essential documents must be included in the TMF, the ISF, or in both folders. The ISF is located in test centers…

The site where a study/trial is being conducted. These sites can be hospital wards, medical practices or other institutions that are selected for the conduct of a clinical trial. Involved departments, such as pharmacies, radiology, cardiology etc. can be affiliated to the study site and conduct examinations within the framework of a trial. The principal…

In medicine, X-rays are used to image bones and internal organs. Because X-rays can cause cancer, the German Radiation Protection Ordinance must be followed. X-rays were discovered in 1895 by German physicist Wilhelm Conrad Röntgen, making him famous across Europe.