15. Is there any legislation which states how and where the code breaks for clinical trials should be stored?

The guidance from the Pharmaceutical Society states that ’The pharmacy should, where possible, hold the code breaks’

The storage location of any code breaks is not specified in the legislation.

What is of concern is the security of the blinding (ie that the blind cannot be broken without it being detected or code breaks removed/accessed by unauthorised personnel), ensuring that the ability to unblind is in place prior to or at the same time that IMP is made available to the investigator and that there is the ability to promptly unblind for a particular subject in an emergency. ICH GCP requires (section 5.13.4, 8.2.17) a documented procedure to be in place to describe how this is to be done. If the investigator only holds the envelopes (or IVRS access codes), what would happen should the investigator be unavailable? Is there an alternative way of breaking the blind? The pharmacy may have a role to play in the process, for example, would the pharmacy be contacted if the investigator/sponsor was unavailable? And is there a documented procedure for this to enable locum staff to follow this procedure? It is the robustness of the process that is important, how it is achieved is the responsibility of the sponsor/organisation.