ADaMIG MD v1.0 scraping for specifications

Class of Dataset,CDISC Notes,Seq. for Order,Data Structure Name,Data Structure Description,SubClass of Dataset,Dataset Name,Dataset Location,Dataset Structure,Documentation,Key Variables of Dataset,Dataset Description,Variable Name,Variable Label,Type,Core,Codelist/Controlled Terms
DEVICE LEVEL ANALYSIS DATASET,"The ADDL is a one-record-per-device or one-record-per-subject-per-device dataset which contains variables that describe device characteristics and timing, and group the devices for analysis. ADDL is the primary source for device-level variables included in other analysis datasets.",1,ADDL,Device-Level Analysis Dataset,,,,,,,,,,,,
MEDICAL DEVICE OCCURRENCE DATA STRUCTURE,The MDOCCDS supports analysis needs by adding SPDEVID as a required identifier and allowing USUBJID be a conditionally required variable. See the OCCDS class for further details.,2,MDOCCDS,Medical Device Occurrence Data Structure,,,,,,,,,,,,
MEDICAL DEVICE BASIC DATA STRUCTURE,The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details.,3,MDBDS,Medical Device Basic Data Structure,,,,,,,,,,,,
MEDICAL DEVICE BASIC DATA STRUCTURE,A dataset containing data that is used for medical device time-to-event analyses.,4,MDTTE,Medical Device Basic Data Structure Medical Device Time-to-Event,MEDICAL DEVICE TIME-TO-EVENT,,,,,,,,,,,
DEVICE LEVEL ANALYSIS DATASET,,1,,,,ADDL,addl.xpt,one record per device (optional: per subject),"SAP, addl.sas","SPDEVID, USUBJID",Device-Level Analysis Dataset,,,,,
MEDICAL DEVICE OCCURRENCE DATA STRUCTURE,,1,,,,ADXXXXXX,adxxxxxx.xpt,"one record per record in SDTM dataset (optional: per coding path, per Analysis Period and/or Phase)","Include additional documentation here, such as dictionary version","List variables, such as (USUBJID, SPDEVID, --SEQ)",<Dataset label>,,,,,
MEDICAL DEVICE OCCURRENCE DATA STRUCTURE,,1,,,,ADXXXXXX,adxxxxxx.xpt,"one record per record in SDTM dataset (optional: per coding path, per Analysis Period and/or Phase)","Include additional documentation here, such as dictionary version","List variables, such as (USUBJID, SPDEVID, --SEQ)",<Dataset label>,,,,,
MEDICAL DEVICE BASIC DATA STRUCTURE,,1,,,,ADMDTTE,admdtte.xpt,"one record per subject (optional), per device, per parameter, per timepoint (optional)",(include additional documentation here),"List variables such as USUBJID, SPDEVID, PARAMCD",Data for Medical Device Time-to-Event Analyses,,,,,
,DI.STUDYID,1,,,,ADDL,,,,,,STUDYID,Study Identifier,Char,Req,
,DI.SPDEVID,2,,,,ADDL,,,,,,SPDEVID,Sponsor Device Identifier,Char,Req,
,"DR.USUBJID. USUBJID is required, when USUBJID is linked to one or more devices (SPDEVID) in SDTM DR dataset.",3,,,,ADDL,,,,,,USUBJID,Unique Subject Identifier,Char,Cond,
,"Character description of a grouping or pooling of devices for analysis purposes. For example, DEVGR1 is the name of a variable containing device group names, where the grouping has been done according to the first device grouping algorithm, defined in variable metadata; DEVGR1 does not mean the first group of devices. If the algorithm of device grouping is based on DI.DEVTYP or DI.MODEL, DEVTYGy or MODELGy should be used.",1,,,,ADDL,,,,,,DEVGRy,Pooled Device Group y,Char,Perm,
,"Numeric representation of grouping ""y"" of the pooled device group. There must be a one-to-one relationship between DEVGRyN and DEVGRy within a study. DEVGRyN cannot be present unless DEVGRy is also present. When DEVGRy and DEVGRyN are present, then on a given record, either both must be populated or both must be null.",2,,,,ADDL,,,,,,DEVGRyN,Pooled Device Group y (N),Num,Perm,
,"Character description of a grouping or pooling of devices for analysis purposes by device type. The value of DI.DIVAL where DI.DIPARMCD ='DEVTYPE' is always used to create the device type grouping variable. For example DEVTYG1 is the name of a variable containing device group names by device type, where the grouping has been done according to the first device type grouping algorithm, defined in variable metadata.",3,,,,ADDL,,,,,,DEVTYGy ,Pooled Device Type Group y,Char,Perm,
,"Numeric representation of grouping ""y"" of the pooled device type group. There must be a one-to-one relationship between DEVTYGyN and DEVTYGy within a study. DEVTYGyN cannot be present unless DEVTYGy is also present. When DEVTYGy and DEVTYGyN are present, then on a given record, either both must be populated or both must be null.",4,,,,ADDL,,,,,,DEVTYGyN,Pooled Device Type Group y (N),Num,Perm,
,"Character description of a grouping or pooling of devices for analysis purposes by device model. The value of DI.DIVAL where DI.DIPARMCD ='MODEL' is always used to create the device model grouping variable. For example, MODELG1 is the name of a variable containing device group names by device model, where the grouping has been done according to the first device model grouping algorithm, defined in variable metadata.",5,,,,ADDL,,,,,,MODELGy ,Pooled Device Model Group y,Char,Perm,
,"Numeric representation of grouping ""y"" of the pooled device type group. There must be a one-to-one relationship between MODELGyN and MODELGy within a study. MODELGyN cannot be present unless MODELGy is also present. When MODELGy and MODELGyN are present, then on a given record, either both must be populated or both must be null.",6,,,,ADDL,,,,,,MODELGyN ,Pooled Device Model Group y (N),Num,Perm,
,"Date of first exposure to the device for the subject. ""First exposure"" to device is defined in the SAP. For example, DEVSDT might be defined as the Date Device Implanted or Date Device Turned On. Note that individual dates for device implanted or device turned on can be captured in more specific variables shown below. Similar to the TRTSDT variable from ADSL, DEVSDT is used for analysis when merged onto other device analysis datasets.",1,,,,ADDL,,,,,,DEVSDT,Date of First Exposure to Device,Num,Req,
,"Date of last exposure to the device for the subject. ""Last exposure"" to device is defined in the SAP. For example, DEVEDT might be defined as the Date Device Explanted or Date Device Turned Off. Note that individual dates for device explanted or device turned off can be captured in more specific variables shown below. Similar to the TRTEDT variable from ADSL, DEVEDT is used for analysis when merged onto other device analysis datasets.",2,,,,ADDL,,,,,,DEVEDT,Date of Last Exposure to Device,Num,Req,
,"DEVAFL indicates whether device is active at a time point specified in the SAP, such as at the time of the cutoff date for an interim analysis, or the date of final database lock, or a particular study milestone date such as subject completion of an analysis period or analysis phase. The SAP provides the definition of an active device. For example, one study could define that any implanted device remaining in the subject is considered active. Another study may only consider the device is turned on as active, and a device not turned on even though it remains in the subject as not active. It is permissible to use DEVAyFL if multiple flags are needed, with labels ""Device Active y Flag"". \n A simple derivation might be to set this flag to ""Y"" when DEVEDT is missing. \n As described in the ADaMIG, character flag (or indicator) variables whose names end in FL can have at most two possible non-missing values, Y or N (i.e., yes or no). If it satisfies the analysis need, the values of just Y and missing can be used instead of Y and N.",3,,,,ADDL,,,,,,DEVAFL,Device Active Flag,Char,Perm,(NY)
,Date device implanted in the subject. DEVIPDT is required when device is implanted. ,1,,,,ADDL,,,,,,DEVIPDT,Date Device Implanted,Num,Cond,
,Date device explanted from the subject. DEVXPDT is required when device is explanted or DEVIPDT is present.,2,,,,ADDL,,,,,,DEVXPDT,Date Device Explanted,Num,Cond,
,"Date device is turned on. DEVONDT is required when the device is able to be turned on. \n Note that some devices may be turned on and off multiple times. If there are records in SDTM for each occurrence of the device being turned on, either \n * collapse into 1 record in ADDL, where the algorithm for deriving DEVONDT is defined in the SAP; or \n * use DEVONyDT. \n The analysis needs specified in the SAP determine whether to include a single collapsed date or a set of dates.",1,,,,ADDL,,,,,,DEVONDT,Date Device Turned On,Num,Cond,
,"Date device is turned off. DEVOFDT is required when the device is able to be turned off, or DEVONDT is present. \n Note that some devices may be turned on and off multiple times. If there are records in SDTM for each occurrence of the device being turned off, eithercollapse into 1 record in ADDL, where the algorithm for deriving DEVOFDT is defined in the SAP; oruse DEVOFyDT.The analysis needs specified in the SAP determine whether to include a single collapsed date or a set of dates.",2,,,,ADDL,,,,,,DEVOFDT,Date Device Turned Off,Num,Cond,
,"DEVRPDT indicates date when device was repositioned. DEVRPDT is required when a device could be repositioned and included in analysis. \n Note that some devices may be repositioned multiple times. If there are records in SDTM for each occurrence of the device being repositioned, either \n * collapse into 1 record in ADDL, where the algorithm for deriving DEVRPDT is defined in the SAP; or \n * use DEVRPyDT. \n The analysis needs specified in the SAP determine whether to include a single collapsed date or a set of dates.",1,,,,ADDL,,,,,,DEVRPDT,Date Device Repositioned,Num,Cond,
,"DEVMDDT indicates date when device was modified for a subject in a study. The device modification or maintenance could be done surgically or externally depending on device. What would qualify as device modification is defined by study protocol and SAP. DEVMDDT is required when the device could be modified and included in analysis. \n Note that some devices may be modified multiple times. If there are records in SDTM for each occurrence of the device being modified, eithercollapse into 1 record in ADDL, where the algorithm for deriving DEVMDDT is defined in the SAP; oruse DEVMDyDT.The analysis needs specified in the SAP determine whether to include a single collapsed date or a set of dates.",2,,,,ADDL,,,,,,DEVMDDT,Date Device Modified,Num,Cond,
,"Age of the subject at DEVSDT. Used only if age at device exposure start date is needed for analysis. Otherwise, use ADSL.AGE.",1,,,,ADDL,,,,,,AGEDST,Subject Age at First Exposure to Device,Num,Perm,
,"Age unit usually is same as the ADSL.AGEU. If it is different, then AGEDSTU is required.",2,,,,ADDL,,,,,,AGEDSTU,Age at First Exposure to Device Unit,Char,Cond,(AGEU)
,ADDL.SPDEVID.,1,,,,,,,,,,SPDEVID,Sponsor Device Identifier,Char,Req,
,ADDL.USUBJID. USUBJID is required when subject-device relationship is defined in ADDL.,2,,,,,,,,,,USUBJID,Unique Subject Identifier,Char,Cond,
,"Sequence number given to ensure uniqueness of records within an ADaM dataset. ASEQ uniquely indexes records within a subject, or within a device, or within a subject and device; within an ADaM dataset. As long as values are unique within the appropriate key(s) (subject, device, or the combination of subject and device, whichever is appropriate for the dataset), any valid number can be used for ASEQ. ASEQ is useful for traceability when the dataset is used as input to another ADaM dataset. To refer to a record in a predecessor ADaM dataset, set SRCDOM to the name of the predecessor dataset, and set SRCSEQ to the value of ASEQ in the predecessor dataset.",3,,,,,,,,,,ASEQ,Analysis Sequence Number,Num,Perm,
,ADDL.SPDEVID.,1,,,,,,,,,,SPDEVID,Sponsor Device Identifier,Char,Req,
,ADDL.USUBJID. USUBJID is required when subject-device relationship is defined in ADDL.,2,,,,,,,,,,USUBJID,Unique Subject Identifier,Char,Cond,