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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…