Description

A findings domain that contains the device characteristics that do not vary over the course of the study.

do.xpt, Device Properties — Findings. One record per property per device, Tabulation, Tabulation.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDOIdentifierTwo-character abbreviation for the domain.Req
SPDEVIDApplicant Device IdentifierChar
Identifier

Applicant-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, combination of identifiers).

Req
DOSEQSequence NumberNum
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
DOGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a device.Perm
DOREFIDReference IDChar
Identifier

Internal or external identifier.

This could be a scan code or equivalent.

Perm

DOSPID

Applicant-Defined IdentifierChar
IdentifierApplicant-defined reference number.Perm
DOTESTCDDevice Property Short NameChar(DOTESTCD)Topic

Short name of the measurement, test, or examination described in DOTEST.

It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DOTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DOTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SHLFLIFE", "INDC", "COMPOS".

Req
DOTESTDevice Property Test NameChar(DOTEST)Synonym Qualifier

Verbatim name of the test or examination used to obtain the measurement or finding.

The value in DOTEST cannot be longer than 40 characters. Examples: "Shelf Life", "Indication for use", "Composition" (of device).

Req
DOCATCategory for Device In-UseChar
Grouping Qualifier

Defines a category of related records.

For example, it can be used to define the type of property being defined, such as "DIMENSIONS" versus "MATERIAL".

Perm
DOSCATSubcategory for Device In-UseChar
Grouping Qualifier

A further categorization of a measurement or examination.

For example, if DOCAT = "DIMENSION", DOSCAT might be "LENGTH" or "WIDTH" or "THICKNESS".

Perm
DOORRESResult or Finding in Original UnitsChar
Result Qualifier

Result of the Device Property as originally observed or collected.

DOORRES should contain the result or value of the property defined in DOTEST. For example, if DOTEST is LIFE (shelf life), then DOORRES might be 6 (months).

Exp
DOORRESUOriginal UnitsChar(UNIT)Variable Qualifier

Original units in which the data were collected.

The unit for DOORRES. Examples: "MONTHS", "cm".

Exp

Assumptions

  1. Definition: Device Properties (DO) is a Findings domain and defines important characteristics of a device that the applicant wishes to include in the submission but that do not form part of the unique applicant-defined identification of the device. If there are no non-identifier characteristics to submit, this domain may not be necessary.
  2. Each property is identified using controlled terminology and is stored in DOTESTCD/DOTEST, which allows the property names to be values in DOTESTCD in an SDTM-based vertical (normalized) structure and variable names in a CDASH horizontal (non-normalized) structure, if necessary. The controlled terminology has not yet been identified.
  3. There should be 1 record per device property.
  4. Applicants define the properties and levels of granularity that are appropriate to include in this domain.
  5. DO supports all device types (e.g., implantable, imaging, diagnostic), although implementation may vary by device type.
  6. This domain does not define the relationships between tracked components and the overall device. This will be addressed in a future version of the standard.
  7. DO should not contain characteristics that may change during the course of the study for a given device (e.g., dial settings on an imaging machine, software versions). As a result, the domain does not include Timing variables.
  8. Applicants may choose whether to include in DO characteristics of approved products or components that are used in the study in accordance with the approved labeling.
  9. The DO domain can contain data about devices that were not deployed, as there is no subject identifier in DO. It should contain only data that should be submitted with the clinical data; additional manufacturing and quality data may exist elsewhere in the submission and do not need to be included in DO unless the applicant has a specific reason to do so.
  10. DO data would generally be assembled by a applicant, rather than by an investigative site. The data can be captured using a CRF, assembled on a worksheet to support entry of the information into the clinical database, derived manually, or derived electronically from data in other domains or elsewhere.
  11. DOTESTCD values are limited to 8 characters and cannot begin with a number or underscore as they can be used as variable names when the dataset is transposed to a non-normalized structure.
  12. Note that there are no examples currently included in the TIG for this domain.

« SDTM Device-in-Use (DU)

SDTM Disposition (DS) »

  • No labels