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SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

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 Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharAEIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
SPDEVIDSponsor Device IdentifierChar
IdentifierA sequence of characters used by the sponsor to uniquely identify a specific device. Used to represent a device associated in some way with the adverse event. SPDEVID values are defined in the Device Identifiers (DI) domain.Perm
AESEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
AEGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
AEREFIDReference IDChar
IdentifierInternal or external identifier such as a serial number on an SAE reporting form.Perm
AESPIDSponsor-Defined IdentifierChar
IdentifierSponsor-defined identifier. It may be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on an Adverse Events CRF page.Perm
AETERMReported Term for the Adverse EventChar
TopicVerbatim name of the event.Req
AEMODIFYModified Reported TermChar
Synonym QualifierIf AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text.Perm
AELLTLowest Level TermCharMedDRAVariable QualifierDictionary-derived text description of the lowest level term.Exp
AELLTCDLowest Level Term CodeNumMedDRAVariable QualifierDictionary-derived code for the lowest level term.Exp
AEDECODDictionary-Derived TermCharMedDRASynonym QualifierDictionary-derived text description of AETERM or AEMODIFY. Equivalent to the Preferred Term (PT in MedDRA). The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document.Req
AEPTCDPreferred Term CodeNumMedDRAVariable QualifierDictionary-derived code for the preferred term.Exp
AEHLTHigh Level TermCharMedDRAVariable QualifierDictionary-derived text description of the high level term for the primary system organ class (SOC).Exp
AEHLTCDHigh Level Term CodeNumMedDRAVariable QualifierDictionary-derived code for the high level term for the primary SOC.Exp
AEHLGTHigh Level Group TermCharMedDRAVariable QualifierDictionary-derived text description of the high level group term for the primary SOC.Exp
AEHLGTCDHigh Level Group Term CodeNumMedDRAVariable QualifierDictionary-derived code for the high level group term for the primary SOC.Exp
AECATCategory for Adverse EventChar
Grouping QualifierUsed to define a category of related records. Examples: "BLEEDING", "NEUROPSYCHIATRIC".Perm
AESCATSubcategory for Adverse EventChar
Grouping QualifierA further categorization of adverse event. Example: "NEUROLOGIC".Perm
AEPRESPPre-Specified Adverse EventChar(NY)Variable QualifierA value of "Y" indicates that this adverse event was prespecified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms).Perm
AEBODSYSBody System or Organ ClassChar
Record QualifierDictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the 's analyses and summary tables, which may not necessarily be the primary SOC.Exp
AEBDSYCDBody System or Organ Class CodeNumMedDRAVariable QualifierDictionary derived. Code for the body system or organ class used by the applicant When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the applicant's analyses and summary tables, which may not necessarily be the primary SOC.Exp
AESOCPrimary System Organ ClassCharMedDRAVariable QualifierDictionary-derived text description of the primary SOC. Will be the same as AEBODSYS if the primary SOC was used for analysis.Exp
AESOCCDPrimary System Organ Class CodeNumMedDRAVariable QualifierDictionary-derived code for the primary SOC. Will be the same as AEBDSYCD if the primary SOC was used for analysis.Exp
AELOCLocation of EventChar(LOC)Record QualifierDescribes anatomical location relevant for the event (e.g., "ARM" for skin rash).Perm
AESEVSeverity/IntensityChar(AESEV)Record QualifierThe severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE".Perm
AESERSerious EventChar(NY)Record QualifierIs this a serious event? Valid values are "Y" and "N".Exp
AEACNAction Taken with Study ProductChar(ACN)Record Qualifier

Describes actions taken with study product, as the result of the event.

Exp
AEACNOTHOther Action TakenChar
Record QualifierDescribes actions taken unrelated to study product, as the result of the event.Perm
AEACNDEVAction Taken with DeviceChar(DEACNDEV)Record QualifierAn action taken with a device as the result of the event. The device may or may not be a device under study.Perm
AERELCausalityChar
Record Qualifier

Records the investigator's opinion as to the causality of the event to the product. ICH does not establish any required or recommended terms for non-device relatedness. ICH E2A and E2B examples include (up-cased here for alignment to SDTM conventions) terms such as "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED", but these example terms do not establish any conventions or expectations. Controlled terminology may be defined in the future. Check with regulatory authority for population of this variable.

Exp
AERLDEV
Relationship of Event to DeviceChar


Record Qualifier

A judgment as to the likelihood that the device caused the adverse event. The relationship is to a device identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study.

Terminology:

  • In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions.
  • No required Controlled Terminology in US.
Perm

AERELNST

Relationship to Non-Study TreatmentChar
Record QualifierRecords the investigator's opinion as to whether the event may have been due to a treatment other than study drug. May be reported as free text. Example: "MORE LIKELY RELATED TO ASPIRIN USE".Perm
AEPATTPattern of Adverse EventChar
Record QualifierUsed to indicate the pattern of the event over time. Examples: "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT".Perm
AEOUTOutcome of Adverse EventChar(OUT)Record QualifierDescription of the outcome of an event.Perm
AESCANInvolves CancerChar(NY)Record QualifierWas the serious event associated with the development of cancer? Valid values are "Y" and "N". This is a legacy seriousness criterion. It is not included in ICH E2A or E2B.Perm
AESCONGCongenital Anomaly or Birth DefectChar(NY)Record QualifierWas the serious event associated with congenital anomaly or birth defect? Valid values are "Y" and "N".Perm
AESDISABPersist or Signif Disability/IncapacityChar(NY)Record QualifierDid the serious event result in persistent or significant disability/incapacity? Valid values are "Y" and "N".Perm
AESDTHResults in DeathChar(NY)Record QualifierDid the serious event result in death? Valid values are "Y" and "N".Perm
AESHOSPRequires or Prolongs HospitalizationChar(NY)Record QualifierDid the serious event require or prolong hospitalization? Valid values are "Y" and "N".Perm
AESLIFEIs Life ThreateningChar(NY)Record QualifierWas the serious event life-threatening? Valid values are "Y" and "N".Perm
AESODOccurred with OverdoseChar(NY)Record QualifierDid the serious event occur with an overdose? Valid values are "Y" and "N". This is a legacy seriousness criterion. It is not included in ICH E2A or E2B.Perm
AESMIEOther Medically Important Serious EventChar(NY)Record QualifierDo additional categories for seriousness apply? Valid values are "Y" and "N".Perm

AESINTV

Needs Intervention to Prevent ImpairmentChar(NY)Record Qualifier

Records whether medical or surgical intervention was necessary to preclude permanent impairment of a body function, or to prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product. This variable is used in conjunction with the other "seriousness" variables (e.g., fatal, life-threatening). It is part of the US federal government definition of a serious adverse event; see 21 CFR Part 803.3(w)(3).

Perm

AEUNANT

Unanticipated Adverse Device EffectChar(NY)Record Qualifier

Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application),

or

any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. (21 CFR Part 812.3(s)).

This variable applies only to serious AEs and should hold collected data; if the value is derived, it should be held in ADaM.

Perm

AERLPRT

Rel of AE to Non-Dev-Rel Study ActivityChar
Record Qualifier

The investigator's opinion as to the causality of the event as related to other protocol-required activities, actions, or assessments (e.g., medication changes, tests/assessments, other procedures). The relationship is to a protocol-specified, non-device-related activity where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study.

Terminology:

  • In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions.
  • No required Controlled Terminology in US.
Perm

AERLPRC

Rel of AE to Device-Related Procedure

Char
Record Qualifier

The investigator's opinion as to the likelihood that the device-related study procedure (e.g., implant/insertion, revision/adjustment, explant/removal) caused the AE. The relationship is to a device-related procedure where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study.

Terminology:

  • In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions.
  • No required Controlled Terminology in US.
Perm
AECONTRTConcomitant or Additional Trtmnt GivenChar(NY)Record QualifierWas another treatment given because of the occurrence of the event? Valid values are "Y" and "N".Perm
AETOXGRStandard Toxicity GradeChar
Record QualifierToxicity grade according to a standard toxicity scale (e.g., Common Terminology Criteria for Adverse Events, CTCAE). Sponsors should specify the name of the scale and version used in the metadata (see assumption 7d). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2").Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the element within the arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the adverse event. Example: "SCREENING".Perm
AESTDTCStart Date/Time of Adverse EventCharISO 8601 datetime or intervalTimingStart date/time of the adverse event represented in ISO 8601 character format.Exp
AEENDTCEnd Date/Time of Adverse EventCharISO 8601 datetime or intervalTimingEnd date/time of the adverse event represented in ISO 8601 character format.Exp
AESTDYStudy Day of Start of Adverse EventNum
TimingStudy day of start of adverse event relative to the sponsor-defined RFSTDTC.Perm
AEENDYStudy Day of End of Adverse EventNum
TimingStudy day of end of event relative to the sponsor-defined RFSTDTC.Perm
AEDURDuration of Adverse EventCharISO 8601 durationTimingCollected duration and unit of an adverse event. Used only if collected on the CRF and not derived from start and end date/times. Example: "P1DT2H" (for 1 day, 2 hours).Perm
AEENRFEnd Relative to Reference PeriodChar(STENRF)Timing

Describes the end of the event relative to the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point (RFSTDTC) and a discrete ending point (RFENDTC) of the trial.

Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
AEENRTPTEnd Relative to Reference Time PointChar(STENRF)Timing

Identifies the end of the event as being before or after the reference time point defined by variable AEENTPT.

Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.

Perm
AEENTPTEnd Reference Time PointChar
TimingDescription of date/time in ISO 8601 character format of the reference point referred to by AEENRTPT. Examples: "2003-12-25", "VISIT 2".Perm
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