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SDTMIG v3.3 Metadata Check for Domain Specification Table 1.3.1

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. <a href="https://wiki.cdisc.org/x/r37dAg" target="_blank">Release Notes</a>

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharPIIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

Permissible rather than required because events may happen to or with a device that do not involve subjects, and may even be before the device was in contact with a subject. Should be used when the malfunction is associated with a subject's use or possession of the device.

Perm
SPTOBIDSponsor Device IdentifierChar
Identifier

Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product.

Req
PISEQDevice Events Sequence NumberNum
Identifier

Sequence Number given to ensure uniqueness of records.

Req
PISPIDSponsor-Defined IdentifierChar
Identifier

Sponsor-defined reference number.

Perhaps defined in the sponsor's operational database. Note that it does not have to be numeric.

Perm
PITERMReported Term for Device EventChar
Topic

Verbatim name of the observed event.

Examples: "Battery malfunction", "Overheating".

Req
PIMODIFYModified Device Event NameChar
Synonym Qualifier

The modified text for PITERM.

If PITERM is modified, then the modified text is placed here.

Perm
PIDECODDevice Events Dictionary-Derived TermChar*Synonym Qualifier

Dictionary-derived form of the event described in PITERM.

Dictionary-derived text description of PITERM or PIMODIFY. The name and version of the dictionary used to map terms must be provided to reviewers.

Req
PICATCategory of Device EventChar*Grouping Qualifier

Used to define a categorization level for events.

For example, "MALFUNCTION" vs. "CALIBRATION".

Perm
PISCATSubcategory of Device EventChar*Grouping Qualifier

Used to define a further category level for events.

Perm
PIPRESPPre-Specified Device EventChar(NY)Record Qualifier

Used to indicate whether (Y/null) information about a specific event was solicited on the CRF.

For example, PITERM could contain a list of malfunctions that are being specifically evaluated. PIPRESSP would identify those (Y), whereas any spontaneous events would have PIPRESP null.

Perm
PIOCCURDevice Event OccurrenceChar(NY)Record Qualifier

When information about specific events is solicited, PIOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred.

Values are null for events not specifically solicited.

Perm
PISTATDevice Event Collection StatusChar(ND)Record Qualifier

The status indicates that the pre-specified question was not answered.

For example, if equipment operation requires checking, such as checking an event log to detect events. Capturing that the checks were not completed may be relevant to interpreting the study data.

Perm
PIREASNDReason Device Event Not CollectedChar
Record Qualifier

Reason PISTAT was "NOT DONE".

This variable should only be used if there are pre-specified events.

Perm
PISEVDevice Event SeverityChar*Record QualifierDescribes the severity of the event, (e.g, the severity of a malfunction).Perm

PIACNDEV+


Action Taken with DeviceChar*Record Qualifier

Describes Action Taken with respect to the device.

Action Taken may include removal, calibration, reprogramming, and so on. Action is usually in response to some event, for example, a subject's adverse event.

Perm
VISITNUMVisit NumberNum
Timing

Clinical encounter number.

Numeric version of VISIT, used for sorting.

Exp
VISITVisit NameChar
Timing

Protocol-defined description of clinical encounter.

May be used in addition to VISITNUM and/or VISITDY.

Perm
VISITDYPlanned Study Day of VisitNum
Timing

Planned study day of the visit based upon RFSTDTC in Demographics.

This value is usually derived.

Perm
PIDTCDate of Device Event Data CollectionCharISO 8601Timing

Date the device event information was collected.

This may be reported if the event (e.g., malfunction) is discovered on a different date from the event.

Perm
PISTDTCStart Date/Time of Device EventCharISO 8601Timing

Start date/time of the device event.

If the event happened at a single point in time, PISTDTC is used.

Perm
PIENDTCEnd Date/Time of Device EventCharISO 8601Timing

End date/time of the device event.

If an event lasted over a period of time, PIENDTC can be used to capture the end date/time.

Perm
PIDYStudy Day of Start of Tracking EventNum
Timing

Study day of Device Event observation, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.

Perm
PISTDYStudy Day of Device Event StartNum
Timing

Study day of start of Device Event, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.

Perm
PIENDYStudy Day of Device Event EndNum
Timing

Study day of end of Device Event, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFENDTC variable in Demographics.

Perm

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Content: For variable SPTOBID, it is either invalid in the Events class domain or not a recognized domain-specific variable
  • Content: For variable PIACNDEV+, it is either invalid in the Events class domain or not a recognized domain-specific variable
  • Content: Variable Name PIACNDEV+ is longer than 8 characters

1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.

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