Article 16–Article 20 · 5 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.
They shall retain the documents for a longer period, where so required by other applicable requirements or by an agreement between the sponsor and the investigator.
Essential documents shall be archived in a way that ensures that they are readily available, upon request, to the competent authorities.
The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.
Any transfer of ownership of the data or of documents shall be documented. The new owner shall assume responsibility for data retention and archiving in accordance with Article 17.
The sponsor shall appoint individuals within its organisation who are responsible for archives.
Access to archives shall be restricted to the named individuals responsible for the archives.
The media used to store essential documents shall be such that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request.
Any alteration to records shall be traceable.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
