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 |