SDTMIG-MD v1.1 scraping for specifications

Variable Name,Variable Label,Type,"Controlled Terms, Codelist or Format",Role,CDISC Notes,Core
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
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DO,Identifier,Two-character abbreviation for the domain.,Req
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, combination of identifiers).",Req
DOSEQ,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
DOGRPID,Group ID,Char,,Identifier,Used to tie together a block of related records in a single domain for a device.,Perm
DOREFID,Reference ID,Char,,Identifier,Internal or external identifier. This could be a scan code or equivalent.,Perm
DOSPID,Sponsor-Defined Identifier,Char,,Identifier,Sponsor-defined reference number.,Perm
DOTESTCD,Device Property Short Name,Char,(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
DOTEST,Device Property Test Name,Char,(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
DOCAT,Category for Device In-Use,Char,*,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
DOSCAT,Subcategory for Device In-Use,Char,*,Grouping Qualifier,"A further categorization of a measurement or examination. For example, if DOCAT = ""DIMENSION"", DOSCAT might be ""LENGTH"" or ""WIDTH"" or ""THICKNESS"".",Perm
DOORRES,Result or Finding in Original Units,Char,,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
DOORRESU,Original Units,Char,(UNIT),Variable Qualifier,"Original units in which the data were collected. The unit for DOORRES. Examples: ""MONTHS"", ""cm"".",Exp
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DX,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.,Req
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).",Req
DXSEQ,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
DXGRPID,Group ID,Char,,Identifier,"Identifier that ties together a block of related records in a single domain for a subject. For example, if a device is inserted that delivers radiation, DXGRPID could be used to tie the records for the device and the radiation together for each course of therapy.",Perm
DXSPID,Sponsor-Defined Identifier,Char,,Identifier,Sponsor-defined reference number. Examples: a number pre-printed on the CRF as an explicit line identifier or record identifier defined in the sponsor's operational database.,Perm
DXTRT,Name of Device Exposure or Output,Char,,Topic,"Name of the device or the exposure outputs that are delivered or administered via the device. This should match the definitions as described in the trial summary domain and/or the protocol. Example: ""coronary stent"", ""extracorporeal shock wave treatment"", ""hyaluronic acid"".",Req
DXCAT,Category for Device Exposure,Char,*,Grouping Qualifier,"Used to define a category of device exposures. For example, for a subject who had radiation delivered through an implanted catheter, DXCAT could be used to group the radiation records versus the catheter records.",Perm
DXSCAT,Subcategory for Device Exposure,Char,*,Grouping Qualifier,"A further categorization of device exposures. If DXCAT captures the radiation versus catheter records (see DXCAT), then DXSCAT might capture the type of catheter if more than one was used.",Perm
DXDOSE,Exposure per Administration,Num,,Record Qualifier,"Amount of DXTRT administered/delivered per administration. Dose if captured as a numeric value. Dose should only appear once in DXDOSE, DXDOSTXT, or DXDOSTOT.",Perm
DXDOSTXT,Device Exposure Description,Char,,Record Qualifier,"Exposure amount or a range of exposure information collected in text form. Units may be stored in DXDOSU. Example: 200-400, 15-20. Dose should only appear once in DXDOSE, DXDOSTXT, or DXDOSTOT.",Perm
DXDOSU,Device Exposure Units,Char,(UNIT),Variable Qualifier,"Units for DXDOSE, DXDOSTXT, and DXDOSTOT. Examples: ""pulses"", ""ml"".",Perm
DXDOSFRQ,Device Exposure Frequency per Interval,Char,(FREQ),Variable Qualifier,"Exposure frequency per interval. Usually expressed as the number of repeated administrations of DXDOSE within a specific time period. Examples: ""CONTINUOUS"", ""PRN"", ""Q2M"" (every 2 months).",Perm
DXDOSTOT,Total Daily Device Exposure,Num,,Record Qualifier,Total daily exposure of DXTRT using the units in DXDOSU. Total exposure over a period other than day could be recorded in a separate Supplemental Qualifier variable.,Perm
DXDOSRGM,Intended Device Exposure Regimen,Char,,Variable Qualifier,"Text description of the (intended) schedule or regimen for the Intervention. Examples: ""TWO WEEKS ON, TWO WEEKS OFF"".",Perm
DXROUTE,Route of Administration,Char,(ROUTE),Variable Qualifier,"Route of administration for DXTRT. Examples: ""EXTRACORPOREAL"", ""INTRA-ARTICULAR, HEMODIALYSIS"".",Perm
DXLOC,Location of Device Exposure,Char,,Record Qualifier,"Anatomic location of exposure. Examples: ""Knee"", ""Eye"".",Perm
DXLAT,Laterality of Device Exposure,Char,,Variable Qualifier,"Qualifier for anatomical location further detailing laterality. Examples: ""RIGHT"", ""LEFT"", ""BILATERAL"".",Perm
DXADJ,Reason for Exposure Adjustment,Char,,Record Qualifier,Describes reason why the exposure was adjusted from protocol-specified or expected exposure levels. Example: "PAIN".,Perm
DXSTDTC,Start Date/Time of Device Exposure,Char,ISO 8601,Timing,Start date and time of exposure. Defined by the sponsor.,Exp
DXENDTC,End Date/Time of Device Exposure,Char,ISO 8601,Timing,End date and time of exposure. Defined by the sponsor.,Perm
DXSTDY,Study Day of Start of Device Exposure,Num,,Timing,Study day of start of exposure relative to the sponsor-defined RFSTDTC.,Perm
DXENDY,Study Day of End of Device Exposure,Num,,Timing,Study day of end of exposure relative to the sponsor-defined RFSTDTC.,Perm
DXDUR,Duration of Device Exposure,Char,ISO 8601,Timing,Collected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times.,Perm
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DE,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 rather than required because events may happen to or with a device that do not involved subjects, and may even be before the device was in contact with a subject. In these cases there may not be a value for USUBJID.",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, combination of identifiers).",Req
DESEQ,Device Events 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. If there is no USUBJID associated with the event, DESEQ should be unique within each SPDEVID.",Req
DESPID,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. Note that it does not have to be numeric.,Perm
DETERM,Reported Term for Device Event,Char,,Topic,"Verbatim name of the observed event. Examples: ""Screw Breakage"", ""Fissure Formation"", ""Battery Issue"".",Req
DEMODIFY,Modified Device Event Name,Char,,Synonym Qualifier,"The modified text for DETERM. If DETERM is modified, then the modified text is placed here.",Perm
DEDECOD,Device Events Dictionary-Derived Term,Char,*,Synonym Qualifier,Dictionary-derived form of the event described in DETERM. Dictionary-derived text description of DETERM or DEMODIFY. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element.,Req
DECAT,Category of Device Event,Char,*,Grouping Qualifier,"Used to define a categorization level for events. For example, ""MALFUNCTION"" vs. ""CALIBRATION"".",Perm
DESCAT,Subcategory of Device Event,Char,*,Grouping Qualifier,"Used to define a further category level for events. For example, ""EXTERNAL"" vs. ""INTERNAL"".",Perm
DEPRESP,Pre-Specified Device Event,Char,(NY),Record Qualifier,"Used to indicate whether (Y/null) information about a specific event was solicited on the CRF. For example, DETERM could contain a list of malfunctions that are being specifically evaluated. DEPRESP would identify those (Y), whereas any spontaneous events would have DEPREST null.",Perm
DEOCCUR,Device Event Occurrence,Char,(NY),Record Qualifier,"When information about specific events is solicited, DEOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred. Values are null for events not specifically solicited.",Perm
DESTAT,Device Event Collection Status,Char,(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
DEREASND,Reason Device Event Not Collected,Char,,Record Qualifier,Reason DESTAT was "NOT DONE". This variable should only be used if there are pre-specified events.,Perm
DESEV,Device Event Severity,Char,*,Record Qualifier,"Describes the severity of the event, (e.g, the severity of a malfunction).",Perm
DEACNDEV,Action Taken with Device,Char,*,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
VISITNUM,Visit Number,Num,,Timing,"Clinical encounter number. 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
DEDTC,Date of Device Event Data Collection,Char,ISO 8601,Timing,"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
DESTDTC,Start Date/Time of Device Event,Char,ISO 8601,Timing,"Start date/time of the device event. If the event happened at a single point in time, DESTDTC is used.",Perm
DEENDTC,End Date/Time of Device Event,Char,ISO 8601,Timing,"End date/time of the device event. If an event lasted over a period of time, DEENDTC can be used to capture the end date/time.",Perm
DEDY,Study Day of Start of Tracking Event,Num,,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
DESTDY,Study Day of Device Event Start,Num,,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
DEENDY,Study Day of Device Event End,Num,,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
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DT,Identifier,Two-character abbreviation for the domain.,Req
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, combination of identifiers).",Req
DTSEQ,Sequence Number,Num,,Identifier,Sequence Number given to ensure uniqueness of device records within subject records (if applicable) within a domain. May be any valid number. Should be unique within each SPDEVID.,Req
DTTERM,Reported Term for the Tracking Event,Char,*,Topic,"Verbatim or preprinted term for the activity that occurs. Example: ""Shipped"", ""Returned"", ""Installed"", ""Implanted"", ""Explanted"".",Req
DTMODIFY,Modified Reported Term,Char,,Synonym Qualifier,"Modified term entered to allow mapping of verbatim term to dictionary term. If DTTERM is modified to facilitate coding, then DTMODIFY will contain the modified text.",Perm
DTDECOD,Standardized Tracking Term,Char,*,Synonym Qualifier,"Dictionary-derived text description of DTTERM or DTMODIFY. If an external controlled terminology is used, the name and version of the dictionary used to map terms must be provided in a Define-XML ExternalCodeList element.",Perm
DTCAT,Category for Device Tracking Event,Char,*,Grouping Qualifier,"Defines a categorization level for a group of related records. Examples: categorize by tracking event type (e.g., ""DOMESTIC"" vs. ""INTERNATIONAL"").",Exp
DTSCAT,Subcategory for Device Tracking Event,Char,,Grouping Qualifier,Defines a further categorization level for a group of related conditions or events.,Perm
DTPARTY,Party Responsible for the Device,Char,*,Record Qualifier,"Person or organization accountable for the device at the conclusion of the action specified in DTTERM. Describes the person or organization that is accountable for the device defined in DTTERM. For example, if DTTERM=SHIPPED, DTPARTY would contain the transfer recipient (e.g., SITE). If DTTERM=IMPLANTED, DTPARTY would contain SUBJECT.",Req
DTPRTYID,Responsible Party Identifier,Char,,Variable Qualifier,"An identifier for the responsible group/role (e.g. site, subject). The value of the responsible party identified in DTPARTY. For example, if DTPARTY is SUBJECT, DTPRTYID would contain the subject number.",Exp
DTDTC,Date/Time of Tracking Event Collection,Char,ISO 8601,Timing,"Date/Time the tracking event information was collected. Will generally be the same as the date the tracking event started, but it can differ.",Perm
DTSTDTC,Start Date/Time of Tracking Event,Char,ISO 8601,Timing,"Start date/time of tracking event. A tracking event (e.g., SHIPPED, RECEIVED) is usually a point in time, which is why only the start date/time is included. If an event occurs over a longer period, the stop date/time may be included from the SDTM model.",Req
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DR,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. Required, as the purpose of this domain is to link each USUBJID to one or more devices.",Req
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, combination of identifiers) as defined in DI.",Req
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.,Req
DOMAIN,Domain Abbreviation,Char,DI,Identifier,Two-character abbreviation for the domain.,Req
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, combination of identifiers).",Req
DISEQ,Sequence Number,Num,,Identifier,"Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID) within dataset. If there is only one value for DIPARMCD for each value of SPDEVID, then DISEQ will be 1 for all records. DISEQ must be a valid number.",Exp
DIPARMCD,Device Identifier Element Short Name,Char,*,Topic,"Short name of the identifier characteristic of the device (e.g., ""SERIAL"", ""MODEL""). A record with DIPARMCD = ""DEVTYPE"" should be included (see below).",Req
DIPARM,Device Identifier Element Name,Char,*,Synonym Qualifier,"Name of the identifier characteristic of the device. Examples: Serial Number, Model. A record with DIPARM = ""DEVTYPE"" should be included (see below).",Req
DIVAL,Device Identifier Element Value,Char,*,Result Qualifier,"Value for the parameter. Value for the parameter. When DIPARMCD=DEVTYPE it should use controlled terminology defined by FDA in their Preferred Term codelist. FDA has stated a preference for the Global Medical Device Nomenclature (GMDN), but as of the date of this publication, the GMDN is not freely available to the public. In its Unique Device Identification rule, FDA indicated that GMDN will not be required unless it is available to the public at no cost. There is a lookup tool on the FDA website to map GMDN codes to FDA PT codes.",Req