| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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. |
Req |
| EXSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| EXTRT |
Name of Treatment |
Char |
Topic |
Name of the protocol-specified study treatment given during
the dosing period for the observation. |
Req |
| EXGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| EXREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier (e.g., kit number, bottle
label, vial identifier). |
Perm |
| EXSPID |
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. Example: Line number on a CRF Page. |
Perm |
| EXLNKID |
Link ID |
Char |
Identifier |
Identifier used to link related records across domains. |
Perm |
| EXLNKGRP |
Link Group ID |
Char |
Identifier |
Identifier used to link related, grouped records across
domains. |
Perm |
| EXTRT |
Name of Treatment |
Char |
Topic |
Name of the protocol-specified study treatment given during
the dosing period for the observation. |
Req |
| EXCAT |
Category of Treatment |
Char |
Grouping Qualifier |
Used to define a category of EXTRT values. |
Perm |
| EXSCAT |
Subcategory of Treatment |
Char |
Grouping Qualifier |
A further categorization of EXCAT values. |
Perm |
| EXDOSE |
Dose |
Num |
Record Qualifier |
Amount of EXTRT when numeric. Not populated when EXDOSTXT is
populated. |
Exp |
| EXDOSTXT |
Dose Description |
Char |
Record Qualifier |
Amount of EXTRT when non-numeric. Dosing amounts or a range
of dosing information collected in text form. Example: 200-400. Not
populated when EXDOSE is populated. |
Perm |
| EXDOSU |
Dose Units |
Char |
Variable Qualifier |
Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing
protocol-specified values. Examples: ng, mg, mg/kg, mg/m2. |
Exp |
| EXDOSFRM |
Dose Form |
Char |
Variable Qualifier |
Dose form for EXTRT. Examples: TABLET, LOTION. |
Exp |
| EXDOSFRQ |
Dosing Frequency per Interval |
Char |
Variable Qualifier |
Usually expressed as the number of repeated administrations
of EXDOSE within a specific time period. Examples: Q2H, QD, BID. |
Perm |
| EXDOSRGM |
Intended Dose Regimen |
Char |
Variable Qualifier |
Text description of the intended schedule or regimen for the
Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF. |
Perm |
| EXROUTE |
Route of Administration |
Char |
Variable Qualifier |
Route of administration for the intervention. Examples:
ORAL, INTRAVENOUS. |
Perm |
| EXLOT |
Lot Number |
Char |
Record Qualifier |
Lot Number of the intervention product. |
Perm |
| EXLOC |
Location of Dose Administration |
Char |
Record Qualifier |
Specifies location of administration. Examples: ARM, LIP. |
Perm |
| EXLAT |
Laterality |
Char |
Variable Qualifier |
Qualifier for anatomical location further detailing
laterality of the intervention administration. Examples: LEFT,
RIGHT. |
Perm |
| EXDIR |
Directionality |
Char |
Variable Qualifier |
Qualifier for anatomical location further detailing
directionality. Examples: ANTERIOR, LOWER, PROXIMAL, UPPER. |
Perm |
| EXFAST |
Fasting Status |
Char |
Record Qualifier |
Indicator used to identify fasting status. Examples: Y, N. |
Perm |
| EXADJ |
Reason for Dose Adjustment |
Char |
Record Qualifier |
Describes reason or explanation of why a dose is adjusted. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Trial Epoch of the Exposure record. Examples: RUN-IN,
TREATMENT. |
Perm |
| EXSTDTC |
Start Date/Time of Treatment |
Char |
Timing |
The date/time when administration of the treatment indicated
by EXTRT and EXDOSE began. |
Exp |
| EXENDTC |
End Date/Time of Treatment |
Char |
Timing |
The date/time when administration of the treatment
indicated by EXTRT and EXDOSE ended. For administrations considered
given at apoint in time (e.g., oral tablet, pre-filled syringe
injection), where only an administration date/time is collected,
EXSTDTC should be copied toEXENDTC as the standard representation. |
Exp |
| EXSTDY |
Study Day of Start of Treatment |
Num |
Timing |
Study day of EXSTDTC relative to DM.RFSTDTC. |
Perm |
| EXENDY |
Study Day of End of Treatment |
Num |
Timing |
Study day of EXENDTC relative to DM.RFSTDTC. |
Perm |
| EXDUR |
Duration of Treatment |
Char |
Timing |
Collected duration of administration represented in ISO 8601
duration format. Used only if collected on the CRF and not derived
from start and end date/times. |
Perm |
| EXTPT |
Planned Time Point Name |
Char |
Timing |
1. Text Description of time when administration should
occur. 2. This may be represented as an elapsed time relative to a
fixed reference point, such as time of last dose. See EXTPTNUM and
EXTPTREF. |
Perm |
| EXTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numerical version of EXTPT to aid in sorting. |
Perm |
| EXELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time (in ISO 8601 format) relative to the
planned fixed reference (EXTPTREF). This variable is useful where
there are repetitive measures. Not a clock time. Represented in ISO
8601 duration format. |
Perm |
| EXTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by EXELTM,
EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. |
Perm |
| EXTPTREF |
Time Point Reference |
Char |
Timing |
Name of the fixed reference point referred to by EXELTM,
EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. |
Perm |