Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 17

Article 17

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.

Read the full instrument → · Read this in context: CHAPTER 4 — THE TRIAL MASTER FILE AND ARCHIVING →

Other provisions in CHAPTER 4 — THE TRIAL MASTER FILE AND ARCHIVING

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 17 of Commission Directive 2005/28/EC of 8 April 2005 laying down… (LawPlayer, data as of 2026-07-04)

What to look at next

Commission Directive 2005/28/EC of 8 April 2005 laying down…, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year CHAPTER 4 — THE TRIAL MASTER FILE AND ARCHIVING — read this in contextThe surrounding text of the act in order, so you can see what comes before and afterChapters and sections