| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study within the submission. | Req |
| DOMAIN | Domain Abbreviation | Char | DA | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char |
| Identifier | Unique subject identifier within the submission. | Req |
| DASEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| DAGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm |
| DAREFID | Reference ID | Char |
| Identifier | Internal or external identifier such as label number. | Perm |
| DASPID | Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Examples: Line number on the Product Accountability page, product label code. | Perm |
| DATESTCD | Short Name of Accountability Assessment | Char | (DATESTCD) | Topic | Short character value for DATEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters and cannot begin with a number or contain characters other than letters, numbers, or underscores. Example: "DISPAMT", "RETAMT". | Req |
| DATEST | Name of Accountability Assessment | Char | (DATEST) | Synonym Qualifier | Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the product accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: "Dispensed Amount", "Returned Amount". | Req |
| DACAT | Category | Char* |
| Grouping Qualifier | Used to define a category of topic-variable values (e.g., "STUDY PRODUCT).. | Perm |
| DASCAT | Subcategory | Char | * |
| Grouping Qualifier | Used to define a further categorization level for a group of related records. | Perm |
| DAORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the Product Accountability assessment as originally received or collected. | Exp |
| DAORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Unit for DAORRES. | Perm |
| DASTRESC | Result or Finding in Standard Format | Char |
| Result Qualifier | Contains the result value for all Product Accountability assessments, copied or derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DASTRESN. | Exp |
| DASTRESN | 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 DASTRESC. DASTRESN should store all numeric test results or findings. | Perm |
| DASTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized units used for DASTRESC and DASTRESN. | Perm |
| DASTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a product accountability assessment was not done. Should be null or have a value of "NOT DONE". | Perm |
| DAREASND | Reason Not Done | Char |
| Record Qualifier | Reason not done. Used in conjunction with DASTAT when value is "NOT DONE". | Perm |
| VISITNUM | Visit Number | Num |
| Timing | - Clinical encounter numberAn assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Exp |
| VISIT | Visit Name | Char |
| Timing | - ProtocolThe label for a protocol-defined description of a 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 | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm |
| DADTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date and time of the product accountability assessment represented in ISO 8601 character format. | Exp |
| DADY | Study Day of Visit/Collection/Exam | Num |
| Timing | - Study day of product accountability assessment, measured in integer days.
- Algorithm for calculations must be relative to the applicant-defined RFSTDTC in Demographics.
| Perm |