The body of a trial master file for a pivotal phase I study

This paper describes in detail the documentation which would form the body of a Trial Master File for Phase I pivotal investigations filed to render easily and totally auditable all the documentation. The body of a Trial Master File is formed by formal documents (study protocol, research report), by documents to be attached to the research report (clinical report, analytical validation report, statistical report, blank case report form, blank consent form, approval from Ethics Committee), by documents to be kept in file (investigator's brochure, clinical source documentation, clinical trial supplies, filled case report forms, monitoring reports, auditing reports, letters, contracts, faxes, phone notes) and by confidential documents that must be filed in the Clinical Unit only (signed consent forms which contain the subjects' identification).