Archiving approach in the UK: the proper storage of research documents remains an essential aspect of the clinical trials process

Clinical trials involve a complex series of steps from inception through protocol design, recruitment, follow-up, data collection, analysis, and the final presentation of results. An important final component of this process is the archiving of the trial documents. Unfortunately, this is an often neglected function that is dealt with as an afterthought. Despite this, archiving is a legal and regulatory requirement that should be planned and carried out with the same attention to detail as every other aspect of the trial. It can also be a very labor intensive and expensive exercise. In this article what exactly is meant by archiving, what needs to be done to archive, and how it should be executed will be examined. We will focus on the practicalities and will draw upon our experience of archiving large clinical trials in the United Kingdom.