An Adverse Event (AE) is any untoward medical occurrence during a clinical trial. It is irrelevant whether the AE is related to the use of an investigational drug or a medical device. The study doctor records the symptoms of the AE, the severity, the first occurrence, and the end as well as counter-measures in the…
Encyclopedia
Association of German Private Healthcare Insurers
The Association of German Private Healthcare Insurers (PKV) is located in Cologne. Its responsibility is the representation of interests of private health and nursing care insurances and its other members in Germany and Europe. Within this framework, representatives of the association participate in parliament hearings and represent private health insurances to ensure their consideration during…
Audit
Audits, part of quality assurance, may be initiated by the sponsor during or following completion of a clinical trial. Audits are conducted regularly or because of special events. The sponsor will announce an audit visit a few weeks in advance. Normally, the clinical monitor (clinical research associate – CRA) will assist the investigational site in…
Case Report Form (CRF)
The case report form, often referred to as CRF, is used to collect data as part of a clinical trial. CRFs consist of several data fields, where patient data are entered as numbers, letters or codes. Nowadays, eCRFs, electronic case report forms, are commonly used. eCRFs are usually set up as online platforms provided by…
Clinical Research
The first step in the development of a medicinal product is finding an active substance which is then further investigated in preclinical trials. Clinical research refers to the part of the development process when clinical trials involving humans are being conducted. During each phase the risk benefit ratio is determined and reassessed, if necessary.
Clinical Research Associate
Clinical Research Associates (CRAs) or Clinical Monitors are either employees of the sponsor, a CRO or freelancers. On behalf of the sponsor, they monitor the conduct of a clinical trial. Thereby, their main objective is to safeguard the rights and security of the participating patients, the adherence to the study protocol, the conduct in accordance…
Close-Out Visit (COV)
Generally, once the conduct of a clinical trial ends, close-out visits (COV) at the participating investigational sites will take place. A COV is the last visit within a study conducted by the clinical research associate at the investigational site. During the COV, all documents are prepared for archiving which is then performed by the investigational…
Coordinating Investigator
In case of multicentre trials, the sponsor will appoint one the participating investigators to become coordinating investigator (CI) in accordance with § 4 sec. 25 Medicinal Products Act or § 3 sec. 30 Medical Devices Act. The ethics committee responsible for the coordinating investigator automatically becomes the central ethics committee, to which the application for…
Declaration of Helsinki
In clinical research, the Declaration of Helsinki is considered to be one of the most fundamental documents. It lays out the basis for ethical standards that should apply for medical research on humans. The Declaration of Helsinki was adopted during the 18 General Assembly of the World Medical Association (MWA) in 1964. The Declaration of…
Drug Interactions
If two or more medicinal products are taken at the same time, undesired interactions between their active ingredients or excipients may occur. This may have different effects: the effect of the medicinal product may be enhanced or reduced, prolonged or shortened and the point of time when the drug becomes effective might be accelerated or…
Essential Documents
Essential documents are required to proof at any time (even years after completion of the trial) that a study was conducted in accordance with GCP and the protocol as well as the applicable laws. Furthermore, they shall document the integrity and quality of the data collected. ICH GCP chapter 8 lists all essential documents that…
FDA
The U.S. Food and Drug Administration (FDA) is the US federal agency responsible for approving drugs and medical devices. The FDA came into being when its predecessor, the Bureau of Chemistry, which was created in 1906 and tasked with user safety, changed its name in 1930. The FDA falls under the US Department of Health…
Federal Office for Radiation Protection
The Federal Office for Radiation Protection, also known by its German acronym BfS, employs more than 500 people and has its headquarters in Salzgitter. It also has headquarters in Berlin, Neuherberg, Bonn, Rendsburg and Freiburg im Breisgau. BfS is a higher federal authority and part of the Federal Ministry for the Environment, Nature Conservation and…
Finding
When physicians talk about findings, they refer to the result of any given examination of a patient. This may include results of a physical examination, blood tests, imaging procedures (X-rays, ultrasound, MRI scan, CT scan, etc.) and many more. Taking all findings into account the physician will determine their diagnosis. In clinical trials, the data…
German Drug Law
Germany and Austria both have laws regulating the trade of medicinal products. The primary objective of the legislators when enacting these laws is to ensure that only medicinal products that have been proven to be harmless and safe and of a certain quality were put on the market. Furthermore, the laws regulate areas such as…
Informed Consent Form (ICF)
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)
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…
Medicinal Products Act (AMG)
Germany and Austria both have laws regulating the trade of medicinal products. The primary objective of the legislators when enacting these laws is to ensure that only medicinal products that have been proven to be harmless and safe and of a certain quality were put on the market. Furthermore, the laws regulate areas such as…
Monitoring
In accordance with ICH-GCP, monitoring is an essential part of clinical trials and serves their quality control. The Clinical Research Associate (CRA) regularly reviews the rights and safety of patients enrolled, the validity of collected data, the conduct in accordance with the protocol and the GCP, and the adherence to laws and regulations. After each…
National Association of Statutory Health Insurance Funds
The National Association of Statutory Health Insurance Funds is located in Berlin and has been playing an important role in the German health care system since 2008. As the central association of all statutory health and nursing care insurances, it represents their interests – not only in Germany but also Europe-wide and internationally. The association…