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…
Encyclopedia
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…