Trial Design Datasets include TA (Trial Arms), TE (Trial Elements), TV (Trial Visits), TI (Trial Inclusion/Exclusion Criteria) , TS (Trial Summary) . These 5 Trial Design domains provided clear description of overall plan and design of the study. Today we will go over the basics for Trial Arms, it has the structure of one record per planned element per arm. It describes the sequence of Elements in each Epoch for each Arm.
STUDYID DOMAIN ARMCD ARM TEATORD ETCD ELEMENT
TABRANCH TATRANS EPOCH
ETCD: this code value assigned to the variable Element, it can be traced from the Trial Element TE domain. Element: indicates the treatment assigned during an element. ARM: represents planned order of an element in an Arm. ARMCD: defines the coded value and the structure of the drug assignment. crossover study can be complication. *Note: Screen failure ARMCD= SCRNFAIL *Note: Not assigned ARMCD= NOTASSGN Branch: describes the outcome of a branch decision point in the trial design for subjects in the Arm. Transition Rule: any subject to move to other Element than the next one in the sequence. Epoch: the value of the visit associated with the Element in the planned sequence of ARM for which the subject is assigned