Article 16
The documentation referred to Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated. Those documents shall show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements and, in particular, with Annex I to Directive 2001/83/EC. The trial master file shall provide the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority. The content of the essential documents shall be in accordance with the specificities of each phase of the clinical trial. The Commission shall publish additional guidance in order to specify the content of these documents.