VariableName VariableLabel Type Role Note Core
STUDYID Study Identifier Char Identifier Unique identifier for a study within the submission. Req
DOMAIN Domain Abbreviation Char 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 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. Examples: Line number on the Drug Accountability page, drug label code. Perm
DATESTCD Short Name of Accountability Assessment Char 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 Synonym Qualifier Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: Dispensed Amount, Returned Amount. Req
DACAT Category of Assessment Char Grouping Qualifier Used to define a category of related records. Examples: STUDY MEDICATION, RESCUE MEDICATION. Perm
DASCAT Subcategory of Assessment Char Grouping Qualifier Used to define a further categorization level for a group of related records. Perm
DAORRES Assessment Result in Original Units Char Result Qualifier Result of the Drug Accountability assessment as originally received or collected. Exp
DAORRESU Original Units Char Variable Qualifier Unit for DAORRES. Perm
DASTRESC Assessment Result in Std Format Char Result Qualifier Contains the result value for all Drug 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 Assessment Standard Units Char Variable Qualifier Standardized units used for DASTRESC and DASTRESN. Perm
DASTAT Completion Status Char Record Qualifier Used to indicate that a drug accountability assessment was not done. Should be null or have a value of NOT DONE. Perm
DAREASND Reason Not Performed Char Record Qualifier Reason not done. Used in conjunction with DASTAT when value is NOT DONE. 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
DADTC Date/Time of Accountability Assessment Char Timing Exp
DADY Study Day of Accountability Assessment Num Timing 1. Study day of drug accountability assessment, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm