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Description

A findings domain that contains the findings about an event or intervention that cannot be represented within an events or interventions domain record or as a supplemental qualifier.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 AbbreviationCharFAIdentifierTwo-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
FASEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
FAGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
FASPIDApplicant-Defined IdentifierChar
IdentifierApplicant-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.Perm
FATESTCDFindings About Test Short NameCharTopicShort name of the measurement, test, or examination described in FATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FATESTCD cannot contain characters other than letters, numbers, or underscores. Example: "OCCUR". Note that controlled terminology is in a FATESTCD general codelist and in several therapeutic area-specific codelists.Req
FATESTFindings About Test NameChar(FATEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. The value in FATEST cannot be longer than 40 characters. Example:"Occurrence". Note that controlled terminology is in a FATEST general codelist and in several therapeutic area-specific codelists.Req
FAOBJObject of the ObservationChar
Record QualifierUsed to describe the object or focal point of the findings observation that is represented by --TEST. Examples: the term (e.g., "Acne") describing a clinical sign or symptom that is being measured by a severity test; an event (e.g., "VOMIT, where the volume of vomit is being measured by a VOLUME test).Req
FACATCategory for Findings AboutChar
Grouping QualifierUsed to define a category of related records. Examples: "GERD", "PRE-SPECIFIED AE".Perm
FASCATSubcategory for Findings AboutChar
Grouping QualifierA further categorization of FACAT.Perm
FAORRESResult or Finding in Original UnitsChar
Result QualifierResult of the test as originally received or collected.Exp
FAORRESUOriginal UnitsChar(UNIT)Variable QualifierOriginal units in which the data were collected. The unit for FAORRES.Perm
FASTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains the result value for all findings, copied or derived from FAORRES in a standard format or standard units. FASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in FASTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in FAORRES, and these results effectively have the same meaning; they could be represented in standard format in FASTRESC as "NEGATIVE".Exp
FASTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from FASTRESC. FASTRESN should store all numeric test results or findings.Perm
FASTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized unit used for FASTRESC and FASTRESN.Perm
FASTATCompletion StatusChar(ND)Record QualifierUsed to indicate that the measurement was not done. Should be null if a result exists in FAORRES.Perm
FAREASNDReason Not PerformedChar
Record QualifierDescribes why a question was not answered. Example: "Subject refused". Used in conjunction with FASTAT when value is "NOT DONE".Perm
FALOCLocation of the Finding AboutChar(LOC)Record QualifierUsed to specify the location of the clinical evaluation. Example: "ARM".Perm
FALATLateralityChar(LAT)Variable QualifierQualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".Perm
FALOBXFLLast Observation Before Exposure FlagChar(NY)Record QualifierOperationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.Perm
FAEVALEvaluatorChar(EVAL)Record QualifierRole of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR".Perm
VISITNUMVisit NumberNum
Timing
  1. An assigned numeric identifier that aligns to the chronological order of an encounter.
  2. Numeric version of VISIT, used for sorting.
Exp
VISITVisit NameChar
Timing
  1. The label for a protocol-defined encounter.
  2. May be used in addition to VISITNUM and/or VISITDY.
Perm
VISITDYPlanned Study Day of VisitNum
TimingPlanned study day of the visit based upon RFSTDTC in Demographics.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the element within the arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the date/time of the observation. Examples: "SCREENING", "PRODUCT EXPOSURE", "FOLLOW-UP".Perm
FADTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingCollection date and time of findings assessment represented in ISO 8601 character format.Exp
FADYStudy Day of CollectionNum
Timing
  1. Study day of collection, measured as integer days.
  2. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
Perm


Assumptions


  1. The Findings About domain shares all qualities and conventions of findings observations.
  2. Some variables in the events and interventions domains (e.g., OCCUR) represent findings about the whole of the event or intervention. When FA is used to represent findings about a part of the event or intervention (i.e., the assessment has different timing from the event as a whole), the FATEST and FATESTCD values should be the same as the variable name and variable label in the corresponding event or intervention domain.
  3. When data collection establishes a relationship between FA records and an events or interventions record, the relationship should be represented in RELREC.
    1. The FAOBJ variable alone is not sufficient to establish a relationship, because an events or interventions dataset may have multiple records for the same topic (e.g., --TERM or --DECOD, --TRT or --DECOD).
  4. Any Identifier variables, Timing variables, or Findings general observation-class qualifiers may be added to the FA domain, but the following qualifiers should generally not be used: --BODSYS, --MODIFY, --SEV, --TOXGR. 

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