| 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 pre-printed 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”). FATESTCD cannot contain characters other than letters, numbers, or underscores. Example: SEV, OCCUR. |
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 | 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 an event such as VOMIT where the volume of Vomit is being measured by a VOLUME test. |
Req |
| 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 of Location of the Finding About |
Char |
Result Qualifier |
Qualifier for anatomical location or specimen further
detailing laterality. Examples: RIGHT, LEFT, BILATERAL |
| FABLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. The value
should be “Y” or null. |
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 |
1.Clinical encounter number.2.Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1.Protocol-defined description of clinical encounter.2.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 |
| FADTC |
Date/Time of Collection |
Char |
Timing |
Perm |
| FADY | Study Day of Collection | Num | Timing | 1.Study day of collection, measured as integer days.2.Algorithm for calculations must be relative to the sponsor-defined RFSTDTCvariable in Demographics. This formula should be consistent across the submission. | Perm |