Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance) (c. 28)

CHAPTER 4 U.K. THE TRIAL MASTER FILE AND ARCHIVING

Article 20 U.K.

The media used to store essential documents shall be such that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request.

Any alteration to records shall be traceable.