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Release Notes
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
Req
SESEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a domain. Should be assigned to be consistent chronological order.
Req
ETCD
Element Code
Char
Topic
ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.
If an encountered element differs from the planned element to the point that it is considered a new element, then use "UNPLAN" as the value for ETCD to represent this element.
Req
ELEMENT
Description of Element
Char
Synonym Qualifier
The name of the element. If ETCD has a value of "UNPLAN", then ELEMENT should be null.
Perm
TAETORD
Planned Order of Element within Arm
Num
Timing
Number that gives the planned order of the element within the subject's assigned trial arm.