| STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
DU |
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.Expected in this domain as devices may have settings or uses
that either may not involve subjects (e.g., diagnostic tools) or
devices that are removed from the study prior to contact with a
subject (e.g., device has malfunction). |
Exp |
| 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). |
Exp |
| DUSEQ |
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 |
| DUGRPID |
Group ID |
Char |
|
Identifier |
Identifier for a group or block of related records.Used to
tie together a block of related records in a single domain for a
subject or a group of subject related records (e.g., group records
specifying all the settings for a specific imaging scan, such as
field strength, repetition time and echo time). |
Perm |
| DUREFID |
Reference ID |
Char |
|
Identifier |
Internal or external identifier.This could be a scan code or
equivalent. |
Perm |
| DUSPID |
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. |
Perm |
| DUTESTCD |
Device-In-Use Test Short Name |
Char |
(DUTESTCD) |
Topic |
Short name of the measurement, test, or examination
described in DUTEST.It can be used as a column name when converting
a dataset from a vertical to a horizontal format. The value in
DUTESTCD cannot be longer than 8 characters, nor can it start with a
number (e.g., "1TEST"). DUTESTCD cannot contain characters other
than letters, numbers, or underscores. Examples: "COILSTR",
"CNTMEDIA". |
Req |
| DUTEST |
Device-In-Use Test Name |
Char |
(DUTEST) |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the
measurement or finding.The value in DUTEST cannot be longer than 40
characters. Examples: "Coil Strength", "Contrast Media". |
Req |
| DUCAT |
Category for Device-In-Use |
Char |
* |
Grouping Qualifier |
Defines a category of related records.It can be used to
define the type of device for which settings are recorded if DI is
not used (e.g., if the device is not under study); may also be used
to record the type of setting (e.g., "HARDWARE" vs. "SOFTWARE"). |
Perm |
| DUSCAT |
Subcategory for Device-In-Use |
Char |
* |
Grouping Qualifier |
A further categorization of a measurement or examination.For
example, if DUCAT = "SOFTWARE", DUSCAT might be "NOMINAL" or
"POST-ADJUSTMENT". |
Perm |
| DUORRES |
Result or Finding in Original Units |
Char |
|
Result Qualifier |
Result of the measurement as originally received or
collected.DUORRES should contain the setting or other device
condition in effect at the time the device was used. |
Exp |
| DUORRESU |
Original Units |
Char |
(UNIT) |
Variable Qualifier |
Original units in which the data were collected.The unit for
DUORRES. Examples: Tesla, mm. |
Exp |
| DUSTRESC |
Result or Finding in Standard Format |
Char |
|
Result Qualifier |
Contains the result value for all findings, copied or
derived from DUORRES in a standard format or standard units.DUSTRESC
should store all results or findings in character format; if results
are numeric, they should also be stored in numeric format in
DUSTRESN. For example, if a test has results "NONE," "NEG," and
"NEGATIVE" in DUORRES, and these results effectively have the same
meaning, they could be represented in standard format in DUSTRESC as
"NEGATIVE". |
Exp |
| DUSTRESN |
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 DUSTRESC. DUSTRESN
should store all numeric test results or findings. |
Exp |
| DUSTRESU |
Standard Units |
Char |
(UNIT) |
Variable Qualifier |
Standardized unit used for DUSTRESC and DUSTRESN.The unit
for standardized results may or may not be the same as for the
original results. |
Exp |
| VISITNUM |
Visit Number |
Num |
|
Timing |
A clinical encounter number.A Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
|
Timing |
Protocol-defined description of clinical encounter.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.This value is usually derived. |
Perm |
| DUDTC |
Date/Time Device Used with Test/ Setting |
Char |
ISO 8601 |
Timing |
Date/time that the device was used with this setting.This is
not the date/time that the setting was set on the device, but rather
that date/time that a measurement or test was done using that
setting. |
Exp |
| DUDY |
Study Day of Observation |
Num |
|
Timing |
Study day of Device-In-Use measurement, measured as integer
days.Algorithm for calculations must be relative to the
sponsor-defined RFSTDTC variable in Demographics. |
Perm |