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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
IESEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
Req
IESPID
Applicant-Defined Identifier
Char
Identifier
Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Inclusion or Exclusion criteria number from CRF.
Perm
IETESTCD
Inclusion/Exclusion Criterion Short Name
Char
Topic
Short name of the criterion described in IETEST. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "IN01", "EX01".
Req
IETEST
Inclusion/Exclusion Criterion
Char
Synonym Qualifier
Verbatim description of the inclusion or exclusion criterion that was the exception for the subject within the study. IETEST cannot be longer than 200 characters.
Used to define a category of related records across subjects.
Req
IESCAT
Inclusion/Exclusion Subcategory
Char
Grouping Qualifier
A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: "MAJOR", "MINOR".
Epoch associated with the observation date/time of the inclusion/exclusion finding.
Perm
IEDTC
Date/Time of Collection
Char
ISO 8601
Timing
Collection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format.
Perm
IEDY
Study Day of Collection
Num
Timing
Study day of collection of the inclusion/exclusion exceptions, measured as integer days.
Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>