Code-break procedure

The Code-break procedure (pronunciation: /ˈkəʊd breɪk prəˈsiːdʒər/) is a critical process in clinical trials that involves revealing the treatment assignments in a double-blind study. This procedure is typically reserved for emergencies when knowledge of the actual treatment is absolutely necessary for further patient management.

Etymology

The term "Code-break procedure" is derived from the concept of 'breaking' the 'code' or the concealed information about the treatment assignments in a clinical trial.

Procedure

The Code-break procedure is initiated when a serious adverse event occurs, or when the treating physician believes that knowing the actual treatment will significantly affect the patient's further management. The procedure involves unmasking the treatment assignment, which is usually kept confidential to maintain the integrity of the study.

The procedure is strictly regulated, and the decision to break the code should be made in consultation with the principal investigator and the Institutional Review Board (IRB). The details of the event leading to the code break, the decision-making process, and the actions taken after the code break should be thoroughly documented.

Related Terms

Double-blind study: A type of study in which neither the participants nor the experimenters know who is receiving a particular treatment.
Clinical trial: A research investigation involving human subjects that tests the safety and effectiveness of a medical strategy, treatment, or device.
Institutional Review Board (IRB): A committee that reviews and monitors research involving human subjects to ensure ethical standards are met.
Adverse event: Any undesirable experience associated with the use of a medical product in a patient.

External links

Medical encyclopedia article on Code-break procedure
Wikipedia's article - Code-break procedure

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Code-break procedure