1 | BE | STUDYID | Study Identifier | Char | | Identifier | Req | Unique identifier for a study. |
2 | BE | DOMAIN | Domain Abbreviation | Char | | Identifier | Req | Two-character abbreviation for the domain. |
3 | BE | USUBJID | Unique Subject Identifier | Char | | Identifier | Req | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
4 | BE | SPDEVID | Sponsor Device Identifier | Char | | Identifier | Perm | Sponsor-defined identifier for a device. |
5 | BE | BESEQ | Sequence Number | Num | | Identifier | Req | Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1. |
6 | BE | BEGRPID | Group ID | Char | | Identifier | Perm | Optional group identifier, used to link together a block of related records within a subject in a domain. |
7 | BE | BEREFID | Reference ID | Char | | Identifier | Exp | Internal or external identifier for the specimen affected or created by the event. |
8 | BE | BESPID | Sponsor-Defined Identifier | Char | | Identifier | Perm | Optional sponsor-defined reference number. Example: Line number on a CRF page. |
9 | BE | BETERM | Reported Term for the Biospecimen Event | Char | | Topic | Req | Topic variable for an event observation, which is the verbatim or pre-specified name of the event. |
10 | BE | BEMODIFY | Modified Reported Term | Char | | Synonym Qualifier | Perm | If the value for BETERM is modified for coding purposes, then the modified text is placed here. |
11 | BE | BEDECOD | Dictionary-Derived Term | Char | C124297 | Synonym Qualifier | Perm | Dictionary-derived text description of BETERM or BEMODIFY, if applicable. |
12 | BE | BECAT | Category for Biospecimen Event | Char | | Grouping Qualifier | Perm | Used to define a category of topic-variable values. Example: COLLECTION, PREPARATION, TRANSPORT. |
13 | BE | BESCAT | Subcategory for Biospecimen Event | Char | | Grouping Qualifier | Perm | A further categorization of BECAT values. |
14 | BE | BELOC | Anatomical Location of Event | Char | C74456 | Record Qualifier | Perm | Describes the anatomical location relevant for the event (e.g. BRAIN, LUNG). |
15 | BE | BEPARTY | Accountable Party | Char | | Record Qualifier | Perm | Party accountable for the transferable object (e.g. specimen) as a result of the activity performed in the associated BETERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the BEPRTYID variable. |
16 | BE | BEPRTYID | Identification of Accountable Party | Char | | Record Qualifier | Perm | Identification of the specific party accountable for the transferable object (e.g. Specimen) after the action in BETERM is taken. Used in conjunction with BEPARTY. |
17 | BE | VISITNUM | Visit Number | Num | | Timing | Exp | Clinical encounter number. Numeric version of VISIT, used for sorting. |
18 | BE | VISIT | Visit Name | Char | | Timing | Perm | Protocol-defined description of clinical encounter. |
19 | BE | VISITDY | Planned Study Day of Visit | Num | | Timing | Perm | Planned study day of VISIT. Should be an integer. |
20 | BE | BEDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Exp | Date and time of specimen collection. |
21 | BE | BESTDTC | Start Date/Time of Biospecimen Event | Char | ISO 8601 datetime or interval | Timing | Exp | Start date/time of the event. |
22 | BE | BEENDTC | End Date/Time of Biospecimen Event | Char | ISO 8601 datetime or interval | Timing | Exp | End date/time of the event. |
23 | BE | BESTDY | Study Day of Start of Biospecimen Event | Num | | Timing | Perm | Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. |
24 | BE | BEENDY | Study Day of End of Biospecimen Event | Num | | Timing | Perm | Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. |
25 | BE | BEDUR | Duration of Biospecimen Event | Char | ISO 8601 duration | Timing | Perm | Collected duration and unit of a biospecimen event. Used only if collected on the CRF and not derived from start and end date/times. Example: P1DT2H (for 1 day, 2 hours). |