Which document describes how, in an emergency, the identity of blinded investigational product can be revealed without unblinding remaining subjects?

Which document describes how, in an emergency, the identity of blinded investigational product can be revealed without unblinding remaining subjects?

• A. Shipping Records for Investigational Products and Trial-Related Materials
• B. Certificates of Analysis of Investigational Products Shipped
• C. Decoding Procedures for Blinded Trials
• D. Master Randomization List

Answer: (C)

In blinded trials, showing the exact identity of a blinded investigational product for an individual only when an emergency requires it is managed through decoding procedures. These procedures set out who is authorized to reveal the assignment, under what emergency circumstances it can be done, and how the event is documented and tracked to protect the blinding of the rest of the study. By defining a controlled, auditable process for decoding, they allow the necessary safety decision to be made for a single subject without exposing the treatment assignments for all participants. Shipping records show what materials were sent and when; they don’t provide a controlled mechanism for unblinding in an emergency. Certificates of analysis confirm product quality and identity but do not address how to reveal identity in an emergency. The master randomization list contains the full allocation and would unblind everyone if disclosed; decoding procedures are specifically designed to limit unblinding to the required subject under proper safeguards.

In blinded trials, showing the exact identity of a blinded investigational product for an individual only when an emergency requires it is managed through decoding procedures. These procedures set out who is authorized to reveal the assignment, under what emergency circumstances it can be done, and how the event is documented and tracked to protect the blinding of the rest of the study. By defining a controlled, auditable process for decoding, they allow the necessary safety decision to be made for a single subject without exposing the treatment assignments for all participants.

Shipping records show what materials were sent and when; they don’t provide a controlled mechanism for unblinding in an emergency. Certificates of analysis confirm product quality and identity but do not address how to reveal identity in an emergency. The master randomization list contains the full allocation and would unblind everyone if disclosed; decoding procedures are specifically designed to limit unblinding to the required subject under proper safeguards.