" /> Planned Activity Blinded Description - CISMeF





Preferred Label : Planned Activity Blinded Description;

NCIt related terms : PlannedActivity.blindedDescription;

NCIt definition : The textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator).;

Alternative definition : BRIDG 3.0.3: The textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator). EXAMPLE(S): During the second treatment epoch of a study, Arms A and B are still blinded and Arm C is no longer blinded. So, Arm A and B must have identical blindedDescriptions. In a study with 3 arms, Arm 1: standard vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 2: new vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 3: new vaccine given in two shots at 2 months and 5 months of age. Subjects assigned to the third arm are unblinded at some point during 5 months and 12 months. By the time of the Third Shot Epoch, the Arm 3/Third Shot activity can be called by this, its unblinded name. However, the Arm 1/Third Shot and Arm2/Third Shot activities still need blinded names. Both these activities would have the blinded name (something like) 3-shot Arm/Third Shot.; BRIDG 5.3: The textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator). EXAMPLE(S): During the second treatment epoch of a study, Arms A and B are still blinded and Arm C is no longer blinded. So, Arm A and B must have identical blindedDescriptions. In a study with 3 arms, Arm 1: standard vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 2: new vaccine given in three shots at 2 months, 5 months, and 12 months of age; Arm 3: new vaccine given in two shots at 2 months and 5 months of age. Subjects assigned to the third arm are unblinded at some point during 5 months and 12 months. By the time of the Third Shot Epoch, the Arm 3/Third Shot activity can be called by this, its unblinded name. However, the Arm 1/Third Shot and Arm2/Third Shot activities still need blinded names. Both these activities would have the blinded name (something like) 3-shot Arm/Third Shot. OTHER NAME(S): NOTE(S):;

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11/05/2024


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