| Description | The textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator).
For example:
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 blinded descriptions.
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". |
Activity Nm
