ADaMIG for NCA v1.0 scraping for specifications

Class of Dataset,Dataset Name,CDISC Notes,Seq. for Order,Data Structure Name,Data Structure Description,SubClass of Dataset,Variable Name,Variable Label,Type,Codelist/Controlled Terms,Core
BASIC DATA STRUCTURE,ADNCA,"Dataset designed to support NCA . Primarily sourced from SDTM PC and supplemented by information from the EX, EC, or other relevant domains. ",1,ADNCA,Basic Data Structure Non-Compartmental Analysis,NON-COMPARTMENTAL ANALYSIS,,,,,
,,"Flag for exclusion of a record into a PK NCA calculation (Y = exclusion, Null = inclusion)",1,,,,NCAXFL,PK NCA Exclusion Flag ,Char,Y,Perm
,,"Numeric flag for exclusion of a record into a PK NCA calculation (1 = exclusion, Null = inclusion). NCAXFN can only be included if NCAXFL is also included.",2,,,,NCAXFN,PK NCA Exclusion Flag (N),Num,1,Perm
,,This variable is used to explain why the record is not included in the PK NCA. ,3,,,,NCAwXRS,Reason w for PK NCA Exclusion,Char,,Perm
,,This variable is used to explain why the record is not included in the PK NCA.,4,,,,NCAwXRSN,Reason for PK NCA Exclusion of w (N),Num,,Perm
,,"Flag for exclusion of a record from a PK summary (1 = exclusion, Null = inclusion)",5,,,,PKSUMXF,PK Summary Exclusion Flag,Char,Y,Perm
,,"Numeric flag for exclusion of a record from a PK summary (1 = exclusion, Null = inclusion). PKSUMXFN can only be included if PKSUMXFL is also included.",6,,,,PKSUMXFN,PK Summary Exclusion Flag (N),Num,1,Perm
,,Flag to designate if observations within a subject are associated with a metabolite. Required if parent drug and metabolites are present in the dataset.,7,,,,METABFL,Metabolite Flag,Char,Y,Cond
,,Relevant to trials where cohorts are defined. This could be another grouping not necessarily associated with ARM.,8,,,,COHORT,Subject Cohort ,Char,,Perm
,,"Numeric representation of the COHORT variable. There must be a one-to-one mapping between COHORT and COHORTN. When COHORT and COHORTN are present, then, on a given record, either both must be populated or both must be null.",9,,,,COHORTN,Subject Cohort (N),Num,,Perm
,,Route of treatment delivery. This variable can be a copy of EX.EXROUTE or EC.ECROUTE. May instead be derived from the EX.EXROUTE or EC.ECROUTE.,10,,,,ROUTE,Route,Char,(ROUTE),Perm
,,Planned time between 2 consecutive treatments in multiple-dose studies (sometimes referred to as "Tau"),11,,,,TRTRINT,Planned Treatment Interval,Num,,Perm
,,Units associated with TRTRINT,12,,,,TRTRINTU,Planned Treatment Interval Units,Char,(UNIT),Perm
,,Derived variable using a standard percent difference formula: (100*(DOSEA-DOSEP)/(DOSEP)). DOSPCTDF is required if both DOSEA and DOSEP are populated.,13,,,,DOSPCTDF,Percent Diff. Nominal vs. Actual Dose,Num,,Cond
,,Usually expressed as the number of repeated administrations of DOSE within a specific time period for multiple dose studies.,14,,,,DOSEFRQ,Dose Frequency,Char,(FREQ),Cond
,,"This is a record-level identifier that reflects cycle and may be of particular importance for studies that examine concentrations in cancer patients. There must be a one-to-one mapping between ACYCLE and ACYCLEC. When ACYCLE and ACYCLEC are present, then, on a given record, either both must be populated or both must be null.",15,,,,ACYCLE,Analysis Cycle,Num,,Perm
,,"Character representation of the ACYCLE variable. Text characterizing to which analysis cycle the record belongs. This is a record-level identifier that reflects cycle and may be of particular importance for studies that examine concentrations in cancer patients. There must be a one-to-one mapping between ACYCLE and ACYCLEC. When ACYCLE and ACYCLEC are present, then, on a given record, either both must be populated or both must be null.",16,,,,ACYCLEC,Analysis Cycle (C),Char,,Perm
,,Date of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. Note that FANLDT may not match TRTSDT or any of TRxxSDT values.,17,,,,FANLDT,First Date of Dose for Analyte,Num,,Perm
,,"Time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the start time of the first dose.",18,,,,FANLTM,First Time of Dose for Analyte,Num,,Perm
,,"Date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the start date and time of the first dose.",19,,,,FANLDTM,First Datetime of Dose for Analyte,Num,,Perm
,,End date of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. Note that FANLEDT may not match TRTEDT or any of TRxxEDT values.,20,,,,FANLEDT,First End Date of Dose for Analyte,Num,,Perm
,,"End time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the end time of the first dose.",21,,,,FANLETM,First End Time of Dose for Analyte,Num,,Perm
,,"End date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the end date and time of the first dose.",22,,,,FANLEDTM,First End Datetime of Dose for Analyte,Num,,Perm
,,"Date of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration. ",23,,,,PCRFTDT,Reference Date of Dose for Analyte,Num,,Req
,,"Time of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration.",24,,,,PCRFTTM,Reference Time of Dose for Analyte,Num,,Req
,,"Date and time of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration.",25,,,,PCRFTDTM,Reference Datetime of Dose for Analyte,Num,,Req
,,"The end date of reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.",26,,,,PCRFEDT,Reference End Date of Dose for Analyte,Num,,Cond
,,"The end time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.",27,,,,PCRFETM,Reference End Time of Dose for Analyte,Num,,Cond
,,"The end date and time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.",28,,,,PCRFEDTM,Ref. End Datetime of Dose for Analyte,Num,,Cond
,,"This is the planned elapsed time (for sample point or start of sampling interval) from first exposure to treatment associated with PARAM and ANALYTE. For studies with an extended duration infusion, use the define to document if this is from the start or end of the infusion.",29,,,,NFRLT,Nom. Rel. Time from Analyte First Dose,Num,,Perm
,,This is the actual elapsed time (for sample point or start of sampling interval) from first exposure to treatment associated with PARAM and ANALYTE. Note that this is referring to the first dose available for a particular drug. It is useful in multiple-dosing situations. ,30,,,,AFRLT,Act. Rel. Time from Analyte First Dose,Num,,Perm
,,This is the planned elapsed end time of sampling interval from first exposure to study treatment.,31,,,,NEFRLT,Nom. Rel. End Time from First Dose,Num,,Perm
,,This is the actual elapsed end time of sampling interval from first exposure to study treatment.,32,,,,AEFRLT,Act. Rel. End Time from First Dose,Num,,Perm
,,This is the unit for all elapsed times from first dose.,33,,,,FRLTU,Rel. Time from First Dose Unit,Char,(PKUNIT),Perm
,,This is the planned elapsed time (for sample point or start of sampling interval) from reference exposure to study treatment. ,34,,,,NRRLT,Nominal Rel. Time from Ref. Dose ,Num,,Req
,,This is the actual elapsed time (for sample point or start of sampling interval) from reference exposure to study treatment. ,35,,,,ARRLT,Actual Rel. Time from Ref. Dose,Num,,Req
,,"This variable could be used to modify the ARRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based of TMPCTDF).",36,,,,MRRLT,Modified Rel. Time from Ref. Dose,Num,,Perm
,,This is the planned elapsed end time of sampling interval from reference exposure to study treatment.,37,,,,NERRLT,Nominal Rel. End Time from Ref. Dose ,Num,,Perm
,,This is the actual elapsed end time of sampling interval from reference exposure to study treatment.,38,,,,AERRLT,Actual Rel. End Time from Ref. Dose,Num,,Perm
,,"This variable could be used to modify the AERRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based on TMPCTDF).",39,,,,MERRLT,Modified Rel. End Time from Ref. Dose,Num,,Perm
,,This is the unit for all elapsed times from reference dose.,40,,,,RRLTU,Rel. Time from Ref. Dose Unit,Char,(PKUNIT),Req
,,This is the percent difference between nominal and actual time. It is derived by using the standard percent difference formula: 100*( NRRLT - ARRLT)/( NRRLT).,41,,,,TMPCTDF,Percent Diff. Nominal vs. Actual Time,Num,,Perm
,,"Total treatment duration, as measured in units given in DOSEDURU, derived from PCRFEDTM-PCRFDTM. This record is generally considered to be associated with an infusion dose and is distinct from TRTDURD, TRTDURM, and TRTDURY, which reference the duration of the entire study rather than the duration of a single treatment event.",42,,,,ADOSEDUR,Actual Duration of Treatment Dose,Num,,Cond
,,"Nominal treatment duration as specified in the protocol, as measured in units given in DOSEDURU. This record is generally considered to be associated with an infusion dose.",43,,,,NDOSEDUR,Nominal duration of Treatment Dose,Num,,Cond
,,"Units associated with ADOSEDUR and NDOSEDUR. When ADOSEDUR is present, NDOSEDUR and/or DOSEDURU must also be included in the dataset.",44,,,,DOSEDURU,Duration of Treatment Dose Units,Char,(PKUNIT),Perm
,,Unit for AVAL.,45,,,,AVALU,Analysis Value Unit,Char,,Req
,,"Defines the type of specimen used for a measurement (e.g., SERUM, PLASMA, URINE). This column must be a direct copy of PC.PCSPEC. ",46,,,,PCSPEC,Specimen Material Type,Char,(SPECTYPE),Perm
,,Character results/findings in a standard format. The purpose of this column is to capture which records are BLQ or LLOQ in the AVAL column. This column must be a direct copy of PC.PCSTRESC.,47,,,,PCSTRESC,Character Result/Finding in Std Format,Char,,Cond
,,Standardized unit associated with AVAL. Units associated with AVAL are needed for clear NCAs. This column must be a direct copy of PC.PCSTRESU. ,48,,,,PCSTRESU,Standard Units,Char,(UNIT),Cond
,,Indicates the lower limit of quantitation for an assay. Use if PC.PCLLOQ does not support analysis needs.,49,,,,ALLOQ,Analysis Lower Limit of Quantitation,Num,,Cond
,,Indicates the lower limit of quantitation for an assay. Must be a direct copy of PC.PCLLOQ.,50,,,,PCLLOQ,Lower Limit of Quantitation,Num,,Cond
,,"PC.PCSTRESN from a PC volume record. This is the volume related to AVAL. Conditionally required if sample is interval-based collection, such as urine.",51,,,,VOLUME,Volume Value,Num,,Cond
,,PC.PCSTRESU from a PC volume record. Conditionally required if VOLUME is present.,52,,,,VOLUMEU,Volume Value Unit,Char,(UNIT),Cond
,,"PC.PCSTRESN from a PC specimen weight record, adjustment based on LLOQ rules possible. This is the specimen weight associated with AVAL. Conditionally required if sample is interval based collection, such as a potential non-fluid matrix (e.g., feces).",53,,,,SPWEIGHT,Specimen Weight Value,Num,,Cond
,,PC.PCSTRESU from a PC weight record. Conditionally required if SPWEIGHT is present.,54,,,,SPWEIGHU,Specimen Weight Value Unit,Char,(UNIT),Cond
,,Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. Must be a direct copy of PC.PCGRPID.,55,,,,PCGRPID,Group ID,Char,,Perm
,,PC.PCSEQ associated with AVAL. ,56,,,,PCSEQ,Sequence Number,Num,,Cond
,,DOSEA represents the actual treatment dosage associated with the record. This is the actual numeric amount of the dose used for the NCA analysis and may differ from the EX.EXDOSE.,1,,,,DOSEA,Actual Treatment Dose,Num,,Req
,,"The units for DOSEP and DOSEA. It is permissible to use suffixes such as ""P"" and ""A"" to record different units for DOSEP and DOSEA, with labels modified accordingly.",2,,,,DOSEU,Treatment Dose Units,Char,(UNIT),Req
,,"The analysis visit description; required if an analysis is done by nominal, assigned or analysis visit. AVISIT may contain the visit names as observed (i.e., from SDTM VISIT), derived visit names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. AVISIT is a derived field and does not have to map to VISIT from the SDTM. AVISIT represents the analysis visit of the record, but it does not mean that the record was analyzed. There are often multiple records for the same subject and parameter that have the same value of AVISIT. ANLzzFL and other variables may be needed to identify the records selected for any given analysis. See ADaMIG v1.2, Section 3.3.8, for information about flag variables. AVISIT should be unique for a given analysis visit window. In the event a record does not fall within any predefined analysis time-point window, AVISIT can be populated in any way that the producer chooses to indicate this fact (i.e., blank or ""Not Windowed""). The way that AVISIT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for AVISIT. The values and the rules for deriving AVISIT may be different for different parameters within the same dataset. Values of AVISIT are producer-defined and are often directly usable in clinical study report (CSR) displays.",3,,,,AVISIT,Analysis Visit,Char,,Req