Emergency Code Break In Clinical Trials

The purpose of this SOP is to describe the process for emergency code break (unblinding) of treatment within clinical trials sponsored or co-sponsored by King’s Health Partner Organisations. The KHP CTO has a Master Service Agreement in place with ESMS to provide emergency code break services to all blinded clinical trials.

ESMS provide a 24-hour emergency medical response service for all trials within the scope of this SOP. They operate on-site 24 hours a day, 365 days a year. Information scientists have immediate access to all study documentation, including randomisation information.

SOP: Emergency Code Break In Clinical Trials (.pdf 631kb)

Related Templates

Clinical Trial Enquiry Form (.doc 122KB)

Clinical Trial Enquiry Report (.doc 42KB)