Description

A findings domain that contains the diagnosis of the cause of death for a subject.

dd.xpt, Death Diagnosis and Details — Findings. One record per diagnosis per subject (for unscheduled deaths only), Tabulation.


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDDIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
DDSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DDTESTCDDeath Diagnosis Short NameChar(DDTESTCD)TopicShort name of the measurement, test, or examination described in DDTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DDTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). DDTESTCD cannot contain characters other than letters, numbers, or underscores.Req
DDTESTDeath Diagnosis NameChar(DDTEST)Synonym QualifierLong name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters.Req
DDORRESResult or Findings as CollectedChar
Result QualifierResult of the diagnosis of the subject's cause of death, as originally received or collected.Req
DDSTRESCStandardized Result in Character FormatChar
Result QualifierContains the diagnosis information, copied or derived from DDORRES in a standard format. Examples: UNKNOWN, GAVAGE ERROR.Exp
DDRESCATResult CategoryChar
Variable QualifierUsed to categorize the result of a finding. Examples: EXPOSURE RELATED, NON-EXPOSURE RELATED, UNDETERMINED, ACCIDENTAL, etc.Perm
DDEVALEvaluatorChar
Record QualifierRole of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, VETERINARIAN.Perm
DDDTCDate/TimeCharISO 8601 datetime or intervalTimingThe date/time of subject disposition, in ISO 8601 format.Perm
DDDYStudy DayNum
TimingStudy day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm


Assumptions

  1. The Death Diagnosis and Details (DD) domain captures the diagnosis of the cause of death for a subject.
  2. No records will be present for subjects where a cause of death was not collected. The DD domain should be utilized only for subjects with an unscheduled death. This may include moribund subjects, subjects found dead, accidental deaths, and so on.
  3. The DD domain will not include findings of "planned sacrifice" or other scheduled reasons for termination.
  4. The information in this domain may duplicate "death relationship" information in other domains. The cause of death will be explicitly presented here if available, even when a --DTHREL implies cause of death in another domain.

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