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Encyclopedia

A C D E F G I M N O P R S T X
Trial M Trial S

Trial Master File

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…

Trial site

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…

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