Drug Evaluation Committee 2013-62 Emergency Key Code Holders
Related classification: Other
Initial release date: 04/2014
Revised release date: Mar 2021
Question
Normally, the management of the EMERGENCY KEY CODE is considered to be generally requested by the investigational drug allocation manager, the investigator, or a specialized vendor. In our double-blind comparative study, we had established a procedure where a medical specialist manages the emergency key code during the clinical trial, and if the key needs to be opened in an emergency, the investigator contacts the sponsor, and the sponsor and the medical specialist consult with each other to determine whether the key should be opened.
We believe that the decision to determine the necessity of opening the key through consultation between the sponsor and medical experts (i.e., the key cannot be opened based solely on the judgment of the investigator) may be in violation of GCP Article 16, Paragraph 3.
Also, please give us your opinion on whether it is appropriate for a medical expert, who is in a position to advise the sponsor, to manage the emergency key code.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 16, Paragraph 3 requires the sponsor to be able to immediately identify which drug is the investigational drug in a blinded clinical trial in the event of a medical emergency and to be able to detect a break in the blindness, but does not specify the details of the procedure. If the investigator, etc. can promptly take medically necessary measures, we believe that a procedure such as the one described in your question, in which the sponsor and medical experts consult with each other to determine the opening of the key, would not conflict with the above GCP provisions. In addition, if the requirements of Article 16.3 of the GCP are satisfied, we do not see any problem if the medical expert, who is in a position to advise the sponsor, manages the emergency key code. In any case, it is a prerequisite that the sponsor, including the medical expert, takes necessary measures to ensure the confidentiality of the assigned content (GCP Article 2 Guidance 18 (11)).
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor changes have been made to the description.