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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
DVSEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
Req
DVREFID
Reference ID
Char
Identifier
Internal or external identifier.
Perm
DVSPID
Applicant-Defined Identifier
Char
Identifier
Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF page.
Perm
DVTERM
Protocol Deviation Term
Char
Topic
Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "STUDY PRODUCT ASSIGNMENT DEVIATION").
Req
DVDECOD
Protocol Deviation Coded Term
Char
Synonym Qualifier
Controlled terminology for the name of the protocol deviation. Examples: "STUDY PRODUCT ASSIGNMENT DEVIATION", "EXCLUDED CONCOMITANT MEDICATION".
Perm
DVCAT
Category for Protocol Deviation
Char
Grouping Qualifier
Category of the protocol deviationcriterion.
Perm
DVSCAT
Subcategory for Protocol Deviation
Char
Grouping Qualifier
A further categorization of the protocol deviation.
Perm
TAETORD
Planned Order of Element within Arm
Num
Timing
Number that gives the planned order of the element within the arm.