This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).

Dr Chris Jones is Head of the Unit for Moral Leadership, Faculty of Theology, Stellenbosch University, Stellenbosch, South Africa