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…
Encyclopedia
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…