Code-break Procedure

	Code-break Procedure A code-break procedure is a set of rules which determine when planned unblinding should occur in a blinded experiment. FDA guidelines recommend that sponsors of blinded trials include a code-break procedure in their standard operating procedure A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing misc .... A code-break procedure should only allow a participant to be unblinded before the conclusion of a trial in the event of an emergency. Code-break usually refers to the unmasking of treatment allocation, but can refer to any form of unblinding. Traditionally, each patient's treatment allocation data was stored in a sealed envelopes, which was to be opened to break code. However, this system is prone to abuse. Reports of researchers opening envelopes prematurely or holding the envelopes up to lig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Unblinding In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints. During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experiences a side effect may corre ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Blinded Experiment In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints. During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experiences a side effect may corr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Standard Operating Procedure A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. Some military services (e.g., in the U.S. and the UK) use the term standing (rather than ''standard'') operating procedure, since a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" could suggest that only one (standard) procedure is to be used across all units. The term is sometimes used facetiously to refer to practices that are unconstructive, yet the norm. In the Philippines, for instance, "SOP" is the term for pervasive corruption within the government and its institutions. Clinical research and practice In clinical research, the '' International Council for Harmonisation'' (ICH) defines SOPs as "de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
picture info	Design Of Experiments The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associated with experiments in which the design introduces conditions that directly affect the variation, but may also refer to the design of quasi-experiments, in which natural conditions that influence the variation are selected for observation. In its simplest form, an experiment aims at predicting the outcome by introducing a change of the preconditions, which is represented by one or more independent variables, also referred to as "input variables" or "predictor variables." The change in one or more independent variables is generally hypothesized to result in a change in one or more dependent variables, also referred to as "output variables" or "response variables." The experimental design may also identify control variables that must be h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]