| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | FW | 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. Either USUBJID or POOLID must be populated. | Exp |
| POOLID | Pool Identifier | Char |
| Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm |
| FWSEQ | Sequence Number | Num |
| Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req |
| FWGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment dosing group number. | Perm |
| FWTESTCD | Food/Water Consumption Short Name | Char | (FWTESTCD) | Topic | Short name of the measurement, test, or examination described in FWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FWTESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled values are FC, FCRELBW, WC, and WCRELBW. | Req |
| FWTEST | Food/Water Consumption Name | Char | (FWTEST) | Synonym Qualifier | Long name for FWTESTCD. The value in FWTEST cannot be longer than 40 characters. Extensible controlled values are Food Consumption, Food Consumption Relative to Body Wt, Water Consumption, Water Consumption Relative to Body Wt. | Req |
| FWORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp |
| FWORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp |
| FWSTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains the result value for all findings, copied or derived from FWORRES, in a standard format or standard units. FWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in FWSTRESN. | Exp |
| FWSTRESN | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of FWSTRESC. FWSTRESN should store all numeric test results or findings. | Exp |
| FWSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for FWSTRESC and FWSTRESN. | Exp |
| FWSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in FWORRES. | Perm |
| FWREASND | Reason Not Done | Char |
| Record Qualifier | Describes why FWSTAT is NOT DONE, such as FOOD WET. | Perm |
| FWEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
| FWREASEX | Reason for Exclusion | Char |
| Record Qualifier | The reason the result should be excluded from all calculations. Used only when FWEXCLFL is Y. | Perm |
| FWDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the start of the observation in IS0 8601 format. | Exp |
| FWENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the end of the observation in IS0 8601 format. | Exp |
| FWDY | Study Day of Start of Observation | Num |
| Timing | Study day of the start of the observation, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| FWENDY | Study Day of End of Observation | Num |
| Timing | Study day of the end of the observation, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |