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…