The problem I have with this interpretation is that the Directive uses the phrase "all other documentation pertaining to the trial as long as the product is authorised. This documentation shall include: the protocol.... ". So the reference to documentation in this section includes ALL other documents not specifically mentioned elsewhere that pertain to the trial. The itemised list following are simply examples (hence the word "includes"). In fact the examples quoted also fall into the first category of documents that should be retained for 15 years or approval plus 2 years i.e. the two sections are not mutually exclusive. Furthermore, the Directive, ICH-GCP and Volume 10 makes it clear that the list of documents identified in ICH Chapter 8 is only a minimum list of essential documents. The MHRA have stated explicitly that they expect far more documents to be retained than are represented in this minimum list of essential documents e.g. those identified in the DIA TMF Reference Model. So, it is still not clear to me what documents fall into each of the two categories included in the Directive and why one category or core, essential documents needs to be retained for a shorter period of time than "all other documents pertaining to the trial".