| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
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 |
| FASEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| FAGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| FASPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps preprinted on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. Example: Line number on a CRF. |
Perm |
| FATESTCD |
Findings About Test Short Name |
Char |
Topic |
Short 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. Examples:
"SEV", "OCCUR". Note that controlled terminology is in several
therapeutic area-specific codelists. |
Req |
| FATEST |
Findings About Test Name |
Char |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding. The value in FATEST cannot be longer than 40
characters. Examples: "Severity/Intensity", "Occurrence". Note that
controlled terminology is in several therapeutic area-specific
codelists. |
Req |
| FAOBJ |
Object of the Observation |
Char |
Record Qualifier |
Used to describe the object or focal point of the findings
observation that is represented by --TEST. Examples: the term (such
as Acne) describing a clinical sign or symptom that is being
measured by a Severity test, or |
Req |
| |
|
|
|
an event such as VOMIT, where the volume of Vomit is being
measured by a VOLUME test. |
|
| FACAT |
Category for Findings About |
Char |
Grouping Qualifier |
Used to define a category of related records. Examples:
"GERD", "PRE-SPECIFIED AE". |
Perm |
| FASCAT |
Subcategory for Findings About |
Char |
Grouping Qualifier |
A further categorization of FACAT. |
Perm |
| FAORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the test as originally received or collected. |
Exp |
| FAORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for FAORRES. |
Perm |
| FASTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains 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 |
| FASTRESN |
Numeric Result/Finding in Standard Units |
Num |
Result Qualifier |
Used 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 |
| FASTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for FASTRESC and FASTRESN. |
Perm |
| FASTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that the measurement was not done. Should
be null if a result exists in FAORRES. |
Perm |
| FAREASND |
Reason Not Performed |
Char |
Record Qualifier |
Describes why a question was not answered. Example: "Subject
refused". Used in conjunction with FASTAT when value is "NOT DONE".
|
Perm |
| FALOC |
Location of the Finding About |
Char |
Record Qualifier |
Used to specify the location of the clinical evaluation.
Example: "ARM". |
Perm |
| FALAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". |
Perm |
| FALOBXFL |
Last Observation 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. |
Perm |
| FABLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. The value
should be "Y" or null. Note that FABLFL is retained for backward
compatibility. The authoritative baseline flag for statistical
analysis is in an ADaM dataset. |
Perm |
| FAEVAL |
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). Should be null for records that contain collected or derived
data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR".
|
Perm |
| 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 clinical encounter. May be
used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time of the observation.
Examples: "SCREENING", "TREATMENT", "FOLLOW-UP". |
Perm |
| FADTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of findings assessment represented
in ISO 8601 character format. |
Perm |
| FADY |
Study Day of Collection |
Num |
Timing |
Study day of collection, measured as integer days. Algorithm
for calculations must be relative to the sponsor-defined RFSTDTC
variable in Demographics. This formula should be consistent across
the submission. |
Perm |