| STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
DX |
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 |
| SPDEVID |
Sponsor Device Identifier |
Char |
|
Identifier |
Sponsor-defined identifier for the device.It must be unique
for each tracked unit of the device under study, and can be at
whatever level of granularity the device should be identified (e.g.,
model or serial number, or combination of identifiers). |
Req |
| DXSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence Number given to ensure uniqueness of device records
within subject records within a domain.May be any valid number. It
should be unique within every subject/device combination. |
Req |
| DXGRPID |
Group ID |
Char |
|
Identifier |
Identifier that ties together a block of related records in
a single domain for a subject.For example, if a device is inserted
that delivers radiation, DXGRPID could be used to tie the records
for the device and the radiation together for each course of
therapy. |
Perm |
| DXSPID |
Sponsor-Defined Identifier |
Char |
|
Identifier |
Sponsor-defined reference number.Examples: a number
pre-printed on the CRF as an explicit line identifier or record
identifier defined in the sponsor's operational database. |
Perm |
| DXTRT |
Name of Device Exposure or Output |
Char |
|
Topic |
Name of the device or the exposure outputs that are
delivered or administered via the device. This should match the
definitions as described in the trial summary domain and/or the
protocol.Example: "coronary stent", "extracorporeal shock wave
treatment", "hyaluronic acid". |
Req |
| DXCAT |
Category for Device Exposure |
Char |
* |
Grouping Qualifier |
Used to define a category of device exposures.For example,
for a subject who had radiation delivered through an implanted
catheter, DXCAT could be used to group the radiation records versus
the catheter records. |
Perm |
| DXSCAT |
Subcategory for Device Exposure |
Char |
* |
Grouping Qualifier |
A further categorization of device exposures.If DXCAT
captures the radiation versus catheter records (see DXCAT), then
DXSCAT might capture the type of catheter if more than one was used. |
Perm |
| DXDOSE |
Exposure per Administration |
Num |
|
Record Qualifier |
Amount of DXTRT administered/delivered per
administration.Dose if captured as a numeric value. Dose should only
appear once in DXDOSE, DXDOSTXT, or DXDOSTOT. |
Perm |
| DXDOSTXT |
Device Exposure Description |
Char |
|
Record Qualifier |
Exposure amount or a range of exposure information collected
in text form.Units may be stored in DXDOSU. Example: 200-400, 15-20.
Dose should only appear once in DXDOSE, DXDOSTXT, or DXDOSTOT. |
Perm |
| DXDOSU |
Device Exposure Units |
Char |
(UNIT) |
Variable Qualifier |
Units for DXDOSE, DXDOSTXT, and DXDOSTOT.Examples: "pulses",
"ml". |
Perm |
| DXDOSFRQ |
Device Exposure Frequency per Interval |
Char |
(FREQ) |
Variable Qualifier |
Exposure frequency per interval.Usually expressed as the
number of repeated administrations of DXDOSE within a specific time
period. Examples: "CONTINUOUS", "PRN", "Q2M" (every 2 months). |
Perm |
| DXDOSTOT |
Total Daily Device Exposure |
Num |
|
Record Qualifier |
Total daily exposure of DXTRT using the units in
DXDOSU.Total exposure over a period other than day could be recorded
in a separate Supplemental Qualifier variable. |
Perm |
| DXDOSRGM |
Intended Device Exposure Regimen |
Char |
|
Variable Qualifier |
Text description of the (intended) schedule or regimen for
the Intervention.Examples: "TWO WEEKS ON, TWO WEEKS OFF". |
Perm |
| DXROUTE |
Route of Administration |
Char |
(ROUTE) |
Variable Qualifier |
Route of administration for DXTRT.Examples:
"EXTRACORPOREAL", "INTRA-ARTICULAR, HEMODIALYSIS". |
Perm |
| DXLOC |
Location of Device Exposure |
Char |
|
Record Qualifier |
Anatomic location of exposure.Examples: "Knee", "Eye". |
Perm |
| DXLAT |
Laterality of Device Exposure |
Char |
|
Variable Qualifier |
Qualifier for anatomical location further detailing
laterality.Examples: "RIGHT", "LEFT", "BILATERAL". |
Perm |
| DXADJ |
Reason for Exposure Adjustment |
Char |
|
Record Qualifier |
Describes reason why the exposure was adjusted from
protocol-specified or expected exposure levels.Example: "PAIN". |
Perm |
| DXSTDTC |
Start Date/Time of Device Exposure |
Char |
ISO 8601 |
Timing |
Start date and time of exposure.Defined by the sponsor. |
Exp |
| DXENDTC |
End Date/Time of Device Exposure |
Char |
ISO 8601 |
Timing |
End date and time of exposure.Defined by the sponsor. |
Perm |
| DXSTDY |
Study Day of Start of Device Exposure |
Num |
|
Timing |
Study day of start of exposure relative to the
sponsor-defined RFSTDTC. |
Perm |
| DXENDY |
Study Day of End of Device Exposure |
Num |
|
Timing |
Study day of end of exposure relative to the sponsor-defined
RFSTDTC. |
Perm |
| DXDUR |
Duration of Device Exposure |
Char |
ISO 8601 |
Timing |
Collected duration for a treatment episode.Used only if
collected on the CRF and not derived from start and end date/times. |
Perm |