For many readers, including the vast majority of those outside the US, the term “archive” has a very specific meaning in a regulated environment. An archive is a repository specifically designed for the long-term retention and preservation of documents and records and NOT a pseudonym for a file system or other repository. Whilst an electronic trial master file system may additionally provide appropriate features to be an archive repository too, they are more often 2 separate entities. An electronic trial master file is more usually unlikely to be suitable for retention of trial master file content for periods in excess of 25 years, as required by EU Clinical Trial Regulation 536/2014.