| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviatio n |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| USUBJID |
Unique Subject Identifier |
Char |
Identifier |
Identifier used to uniquely identify a subject across all
studies for all applications or submissions involving the product. |
Req |
| FTSEQ |
Sequence Number |
Num |
Identifier |
Sequence number to ensure uniqueness of records within a
dataset for a subject. May be any valid number. |
Req |
| FTGRPID |
Group ID |
Char |
Identifier |
Optional group identifier, used to link together a block of
related records within a subject in a domain. |
Per m |
| FTREFID |
Reference ID |
Char |
Identifier |
Optional internal or external identifier. |
Per m |
| FTSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. Perhaps preprinted on the CRF as
an explicit line identifier or defined in the sponsor's operational
database. Example: Line number from the test page. |
Per m |
| FTTESTCD |
Short Name of Test |
Char |
Topic |
Short character value for FTTEST, which can be used as a
column name when converting a dataset from a vertical format to a
horizontal format. The value cannot be longer than 8 characters, nor
can it start with a number (e.g., "1TEST" is not valid). FTTESTCD
cannot contain characters other than letters, numbers, or
underscores. Controlled terminology for FTTESTCD is published in
separate codelists for each questionnaire. See
https://www.cdisc.org/standards/semantics/terminology f or values
for FTTESTCD. Examples: "W250101", "W25F0102". |
Req |
| FTTEST |
Name of Test |
Char |
Synony m Qualifier |
Verbatim name of the question used to obtain the finding.
The value in FTTEST cannot be longer than 40 characters. Controlled
terminology for FTTEST is published in separate codelists for each
questionnaire. See
https://www.cdisc.org/standards/semantics/terminology f or values
for FTTEST. Examples: "W2501-25 Foot Walk Time", "W25F-More Than Two
Attempts". |
Req |
| FTCAT |
Category |
Char |
Groupin g Qualifier |
Used to specify the functional test in which the functional
test question identified by FTTEST and FTTESTCD was included. |
Req |
| FTSCAT |
Subcategor y |
Char |
Groupin g Qualifier |
Used to define a further categorization of FTCAT values. |
Per m |
| FTPOS |
Position of Subject During Observatio n |
Char |
Record Qualifier |
Position of the subject during the test. Examples: "SUPINE",
"STANDING", "SITTING". |
Per m |
| FTORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the measurement or finding as originally received
or collected. |
Exp |
| FTORRES U |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. Unit for
FTORRES. |
Per m |
| FTSTRESC |
Result or Finding in Standard Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from FTORRES in a standard format or in standard units.
FTSTRESC should store all results or findings in character format;
if results are numeric, they should also be stored in numeric format
in FTSTRESN. |
Exp |
| FTSTRESN |
Numeric Result/Findi ng in Standard Units |
Num |
Result Qualifier |
Used for continuous or numeric results or findings in
standard format; copied in numeric format from FTSTRESC. FTSTRESN
should store all numeric test results or findings. |
Per m |
| FTSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for FTSTRESC and FTSTRESN. |
Per m |
| FTSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that a test was not done, or a test was
attempted but did not generate a result. Should be null or have a
value of "NOT DONE". |
Per m |
| FTREASND |
Reason Not Done |
Char |
Record Qualifier |
Describes why a test was not done, or a test was attempted
but did not generate a result. Used in conjunction with FTSTAT when
value is "NOT DONE". |
Per m |
| FTXFN |
External File Path |
Char |
Record Qualifier |
File path to an external file. |
Per m |
| FTNAM |
Vendor Name |
Char |
Record Qualifier |
Name or identifier of the vendor or laboratory that provided
the test results. |
Per m |
| FTMETHO D |
Method of Test |
Char |
Record Qualifier |
Method of the test. |
Per m |
| FTLOBXFL |
Last Observatio n Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. The value should be "Y" or
null. |
Exp |
| FTBLFL |
Baseline Flag |
Char |
Record Qualifier |
A baseline defined by the sponsor (could be derived in the
same manner as FTLOBXFL or ABLFL, but is not required to be). The
value should be "Y" or null. Note that FTBLFL is retained for
backward compatibility. The authoritative baseline flag for
statistical analysis is in an ADaM dataset. |
Per m |
| FTDRVFL |
Derived Flag |
Char |
Record Qualifier |
Used to indicate a derived record (e.g., a record that
represents the average of other records such as a computed
baseline). Should be "Y" or null. |
Per m |
| FTEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Used only
for results that are subjective (e.g., assigned by a person or a
group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR",
"RADIOLOGIST". |
Per m |
| FTREPNU M |
Repetition Number |
Num |
Record Qualifier |
The incidence number of a test that is repeated within a
given timeframe for the same test. The level of granularity can
vary, e.g., within a time point or within a visit. For example,
multiple measurements of blood pressure or multiple analyses of a
sample. |
Per m |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of a clinical encounter. |
Per m |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of VISIT based upon RFSTDTC in
Demographics. Should be an integer. |
Per m |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm for the element in which the assessment was made. |
Per m |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the observation date/time of the
functional tests finding. |
Per m |
| FTDTC |
Date/Time of Test |
Char |
Timing |
Collection date and time of functional test. |
Exp |
| FTDY |
Study Day of Test |
Num |
Timing |
Actual study day of test expressed in integer days relative
to the sponsor-defined RFSTDTC in Demographics. |
Per m |
| FTTPT |
Planned Time Point Name |
Char |
Timing |
Text description of time when a measurement or observation
should be taken, as defined in the protocol. This may be represented
as an elapsed time relative to a fixed reference point, such as time
of last dose. See FTTPTNUM and FTTPTREF. |
Per m |
| FTTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of planned time point used in sorting. |
Per m |
| FTELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time relative to a planned fixed reference
(FTTPTREF). Not a clock time or a date/time variable, but an
interval, represented as ISO duration. |
Per m |
| FTTPTREF |
Time Point Reference |
Char |
Timing |
Description of the fixed reference point referred to by
FTELTM, FTTPTNUM, and FTTPT. Examples: "PREVIOUS DOSE", "PREVIOUS
MEAL". |
Per m |
| FTRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point defined by
FTTPTREF. |
Per m |