SEND DU specification

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

Applicant Device Identifier

Char

Identifier

Applicant-defined identifier for the device. The value of SPDEVID may be linked to a nonclinical trial set by a matching value of the parameter APDEVID in the TX dataset.

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.
The value of DUREFID may be linked to a nonclinical trial set by a matching value of the parameter SMKRGM. SMKRGM is an identifier used to represent a smoking regimen in the TX dataset and serves as a link to the Device-In-Use (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine.

Perm

Applicant-Defined Identifier

Char

Identifier

Applicant-defined reference number.

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

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

Char

ISO 8601 datetime or interval

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 applicant-defined RFSTDTC variable in Demographics.

Perm