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"decode": "Resporatory criteria" + }, + { + "codedValue": "EX13", + "decode": "Genitourinary criteria" + }, + { + "codedValue": "EX14", + "decode": "Rheumatologic criteria" + }, + { + "codedValue": "EX15", + "decode": "HIV criteria" + }, + { + "codedValue": "EX16", + "decode": "Neurosyphilis, Meningitis,Encephalitis criteria" + }, + { + "codedValue": "EX17", + "decode": "Malignant disease criteria" + }, + { + "codedValue": "EX18", + "decode": "Ability to participate in study criteria" + }, + { + "codedValue": "EX19", + "decode": "Laboratory values criteria" + }, + { + "codedValue": "EX20", + "decode": "Central laboratory values criteria" + }, + { + "codedValue": "EX21", + "decode": "Syphilia criteria" + }, + { + "codedValue": "EX22", + "decode": "Hemoglobin criteria" + }, + { + "codedValue": "EX23", + "decode": "Medications Criteria" + } + ] + }, + { + "OID": "CL.ELEMENT", + "name": "Description of Element", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Screening" + }, + { + "codedValue": "Placebo" + }, + { + "codedValue": "Follow up" + }, + { + "codedValue": "Low" + }, + { + "codedValue": "High - Start" + }, + { + "codedValue": "High - Middle" + }, + { + "codedValue": "High - End" + } + ] + }, + { + "OID": "CL.ETCD", + "name": "Element Code", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "EL1", + "decode": "Screening" + }, + { + "codedValue": "EL2", + "decode": "Placebo" + }, + { + "codedValue": "EL7", + "decode": "Follow up" + }, + { + "codedValue": "EL3", + "decode": "Low" + }, + { + "codedValue": "EL4", + "decode": "High - Start" + }, + { + "codedValue": "EL5", + "decode": "High - Middle" + }, + { + "codedValue": "EL6", + "decode": "High - End" + } + ] + }, + { + "OID": "CL.EPOCH", + "name": "Epoch", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99079", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Screening", + "coding": { + "code": "C202487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 1", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 2", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 3", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Follow-Up", + "coding": { + "code": "C202578", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.NCOMPLT", + "name": "Completion/Reason for Non-Completion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66727", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSCAT", + "name": "Category of Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74558", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSSCAT", + "name": "Subcategory for Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C170443", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY", + "name": "No Yes Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "N", + "decode": "No", + "coding": { + "code": "C49487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Y", + "decode": "Yes", + "coding": { + "code": "C49488", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.AGEU", + "name": "Age Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66781", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SEX", + "name": "Sex", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66731", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "F", + "decode": "Female", + "coding": { + "code": "C16576", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "M", + "decode": "Male", + "coding": { + "code": "C20197", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.RACE", + "name": "Race", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74457", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ETHNIC", + "name": "Ethnic Group", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66790", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ARMNULRS", + "name": "Arm Null Reason", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C142179", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SCTESTCD", + "name": "Subject Characteristic Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74559", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "EDULEVEL", + "decode": "Level of Education Attained", + "coding": { + "code": "C17953", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EDUYRNUM", + "decode": "Number of Years of Education", + "coding": { + "code": "C122393", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.SCTEST", + "name": "Subject Characteristic Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C103330", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Level of Education Attained", + "decode": "Level of Education Attained", + "coding": { + "code": "C17953", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Number of Years of Education", + "decode": "Number of Years of Education", + "coding": { + "code": "C122393", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.UNIT", + "name": "Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "%", + "decode": "Percentage", + "coding": { + "code": "C25613", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^12/L", + "decode": "/pL", + "coding": { + "code": "C67308", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^6/L", + "decode": "/mm3", + "coding": { + "code": "C67452", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^9/L", + "decode": "/nL", + "coding": { + "code": "C67255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CIGAR", + "decode": "Cigar Dosing Unit", + "coding": { + "code": "C116244", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CIGARETTE", + "decode": "Cigarette Dosing Unit", + "coding": { + "code": "C116245", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DRINK", + "decode": "Drink Dosing Unit", + "coding": { + "code": "C161487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EU", + "decode": "Ehrlich Units", + "coding": { + "code": "C96599", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "fmol", + "decode": "Femtomole", + "coding": { + "code": "C68854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "fraction of 1", + "decode": "Proportion of 1", + "coding": { + "code": "C105484", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g", + "decode": "Gram", + "coding": { + "code": "C48155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g/dL", + "decode": "g%", + "coding": { + "code": "C64783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g/L", + "decode": "g/L", + "coding": { + "code": "C42576", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GLASS", + "decode": "Glass Dosing Unit", + "coding": { + "code": "C198391", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IU/L", + "decode": "IE/L", + "coding": { + "code": "C67376", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "kg/m2", + "decode": "Kilogram per Square Meter", + "coding": { + "code": "C49671", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "L", + "decode": "Liter", + "coding": { + "code": "C48505", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mEq/dL", + "decode": "Milliequivalent per Deciliter", + "coding": { + "code": "C67473", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mEq/L", + "decode": "Milliequivalent Per Liter", + "coding": { + "code": "C67474", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg", + "decode": "Milligram", + "coding": { + "code": "C28253", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg/dL", + "decode": "mg%", + "coding": { + "code": "C67015", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg/L", + "decode": "g/m3", + "coding": { + "code": "C64572", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mIU/L", + "decode": "mcIU/mL", + "coding": { + "code": "C67405", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mL", + "decode": "cc", + "coding": { + "code": "C28254", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mmol/L", + "decode": "mcmol/mL", + "coding": { + "code": "C64387", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ms", + "decode": "Millisecond", + "coding": { + "code": "C41140", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mU/L", + "decode": "uU/mL", + "coding": { + "code": "C67408", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ng/dL", + "decode": "Nanogram per Deciliter", + "coding": { + "code": "C67326", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ng/L", + "decode": "Microgram per Cubic Meter", + "coding": { + "code": "C67327", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "nkat/L", + "decode": "Nanokatal per Liter", + "coding": { + "code": "C70510", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "nmol/L", + "decode": "Nanomole per Liter", + "coding": { + "code": "C67432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "oz", + "decode": "Ounce", + "coding": { + "code": "C48519", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PACK", + "decode": "", + "coding": { + "code": "C62653", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "pg", + "decode": "Picogram", + "coding": { + "code": "C64551", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PIPE", + "decode": "Pipe Dosing Unit", + "coding": { + "code": "C116246", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "pmol/L", + "decode": "Femtomole per Milliliter", + "coding": { + "code": "C67434", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "psi", + "decode": "Pounds per Square Inch", + "coding": { + "code": "C67334", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "s", + "decode": "sec", + "coding": { + "code": "C42535", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "U/L", + "decode": "mU/mL", + "coding": { + "code": "C67456", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ug/dL", + "decode": "Microgram per Deciliter", + "coding": { + "code": "C67305", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ug/L", + "decode": "mcg/L", + "coding": { + "code": "C67306", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ukat/L", + "decode": "mckat/L", + "coding": { + "code": "C67397", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "umol/L", + "decode": "nmol/mL", + "coding": { + "code": "C48508", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.STENRF", + "name": "Relation to Reference Period", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66728", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FREQ", + "name": "Frequency", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71113", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Q7D", + "decode": "Every 7 Days", + "coding": { + "code": "C139177", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QD", + "decode": "/day", + "coding": { + "code": "C25473", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.PROCEDUR", + "name": "Procedure", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C101858", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LOC", + "name": "Anatomical Location", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74456", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ARM", + "decode": "Arm", + "coding": { + "code": "C32141", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AXILLA", + "decode": "Armpit", + "coding": { + "code": "C12674", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BACK", + "decode": "Back", + "coding": { + "code": "C13062", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BRACHIAL ARTERY", + "decode": "", + "coding": { + "code": "C12681", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BUTTOCK", + "decode": "Buttock", + "coding": { + "code": "C89806", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CAROTID ARTERY", + "decode": "Common Carotid Artery", + "coding": { + "code": "C12687", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CEREBRAL ARTERY", + "decode": "", + "coding": { + "code": "C12691", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHEST", + "decode": "Chest", + "coding": { + "code": "C25389", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DORSALIS PEDIS ARTERY", + "decode": "Dorsal Pedal Artery", + "coding": { + "code": "C32478", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EAR", + "decode": "", + "coding": { + "code": "C12394", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FEMORAL ARTERY", + "decode": "", + "coding": { + "code": "C12715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FINGER", + "decode": "Finger", + "coding": { + "code": "C32608", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FOREHEAD", + "decode": "Forehead", + "coding": { + "code": "C89803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ORAL CAVITY", + "decode": "Buccal cavity", + "coding": { + "code": "C12421", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RADIAL ARTERY", + "decode": "Radial Artery", + "coding": { + "code": "C12838", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RECTUM", + "decode": "", + "coding": { + "code": "C12390", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "THIGH", + "decode": "Thigh", + "coding": { + "code": "C33763", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSTESTCD", + "name": "Vital Signs Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66741", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "BMI", + "decode": "Body Mass Index", + "coding": { + "code": "C16358", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DIABP", + "decode": "Diastolic Blood Pressure", + "coding": { + "code": "C25299", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HEIGHT", + "decode": "Height", + "coding": { + "code": "C25347", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HR", + "decode": "Heart Rate", + "coding": { + "code": "C49677", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PULSE", + "decode": "Pulse Rate", + "coding": { + "code": "C49676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RESP", + "decode": "Respiratory Rate", + "coding": { + "code": "C49678", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SYSBP", + "decode": "Systolic Blood Pressure", + "coding": { + "code": "C25298", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TEMP", + "decode": "Body Temperature", + "coding": { + "code": "C174446", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "WEIGHT", + "decode": "Weight", + "coding": { + "code": "C25208", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSTEST", + "name": "Vital Signs Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Body Mass Index", + "decode": "Body Mass Index", + "coding": { + "code": "C16358", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Diastolic Blood Pressure", + "decode": "Diastolic Blood Pressure", + "coding": { + "code": "C25299", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Heart Rate", + "decode": "Heart Rate", + "coding": { + "code": "C49677", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Height", + "decode": "Height", + "coding": { + "code": "C25347", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Pulse Rate", + "decode": "Pulse Rate", + "coding": { + "code": "C49676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Respiratory Rate", + "decode": "Respiratory Rate", + "coding": { + "code": "C49678", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Systolic Blood Pressure", + "decode": "Systolic Blood Pressure", + "coding": { + "code": "C25298", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Temperature", + "decode": "Body Temperature", + "coding": { + "code": "C174446", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Weight", + "decode": "Weight", + "coding": { + "code": "C25208", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.POSITION", + "name": "Position", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71148", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "PRONE", + "decode": "Prone", + "coding": { + "code": "C62165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SEMI-RECUMBENT", + "decode": "Semi-Supine", + "coding": { + "code": "C111310", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SITTING", + "decode": "Sitting", + "coding": { + "code": "C62122", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STANDING", + "decode": "Orthostatic", + "coding": { + "code": "C62166", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SUPINE", + "decode": "Supine", + "coding": { + "code": "C62167", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSRESU", + "name": "Units for Vital Signs Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "C", + "decode": "Degree Celsius", + "coding": { + "code": "C42559", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "cm", + "decode": "Centimeter", + "coding": { + "code": "C49668", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "F", + "decode": "Degree Fahrenheit", + "coding": { + "code": "C44277", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g", + "decode": "Gram", + "coding": { + "code": "C48155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "in", + "decode": "Inch", + "coding": { + "code": "C48500", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "K", + "decode": "Kelvin", + "coding": { + "code": "C42537", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "kg", + "decode": "Kilogram", + "coding": { + "code": "C28252", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "LB", + "decode": "lb", + "coding": { + "code": "C48531", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "m", + "decode": "Meter", + "coding": { + "code": "C41139", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "kg/m2", + "decode": "Kilogram per Square Meter", + "coding": { + "code": "C49671", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LAT", + "name": "Laterality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99073", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "LEFT", + "decode": "", + "coding": { + "code": "C25229", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RIGHT", + "decode": "", + "coding": { + "code": "C25228", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.EGTESTCD", + "name": "ECG Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "AVCOND", + "decode": "Atrioventricular Conduction", + "coding": { + "code": "C111131", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AXISVOLT", + "decode": "Axis and Voltage", + "coding": { + "code": "C111132", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHYPTENL", + "decode": "Chamber Hypertrophy or Enlargement", + "coding": { + "code": "C111155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EGHRMN", + "decode": "ECG Mean Heart Rate", + "coding": { + "code": "C119259", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTP", + "decode": "Interpretation", + "coding": { + "code": "C41255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IVTIACD", + "decode": "Intraventricular-Intraatrial Conduction", + "coding": { + "code": "C111238", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PACEMAKR", + "decode": "Pacemaker", + "coding": { + "code": "C111285", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PRAG", + "decode": "PQ Interval, Aggregate", + "coding": { + "code": "C117773", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS_AXIS", + "decode": "QRS Axis", + "coding": { + "code": "C118165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRSAG", + "decode": "QRS Duration, Aggregate", + "coding": { + "code": "C117779", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTAG", + "decode": "QT Interval, Aggregate", + "coding": { + "code": "C117783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTCBAG", + "decode": "QTcB Interval, Aggregate", + "coding": { + "code": "C117784", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTCFAG", + "decode": "QTcF Interval, Aggregate", + "coding": { + "code": "C117786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RHYNOS", + "decode": "Rhythm Not Otherwise Specified", + "coding": { + "code": "C111307", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RRAG", + "decode": "RR Interval, Aggregate", + "coding": { + "code": "C117791", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SNRARRY", + "decode": "Sinus Node Rhythms and Arrhythmias", + "coding": { + "code": "C111312", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPRARRY", + "decode": "Supraventricular Arrhythmias", + "coding": { + "code": "C111320", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPRTARRY", + "decode": "Supraventricular Tachyarrhythmias", + "coding": { + "code": "C111321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TECHQUAL", + "decode": "Technical Quality", + "coding": { + "code": "C117807", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VTARRY", + "decode": "Ventricular Arrhythmias", + "coding": { + "code": "C111330", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VTTARRY", + "decode": "Ventricular Tachyarrhythmias", + "coding": { + "code": "C111331", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.EGTEST", + "name": "ECG Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Atrioventricular Conduction", + "decode": "Atrioventricular Conduction", + "coding": { + "code": "C111131", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Axis and Voltage", + "decode": "Axis and Voltage", + "coding": { + "code": "C111132", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Chamber Hypertrophy or Enlargement", + "decode": "Chamber Hypertrophy or Enlargement", + "coding": { + "code": "C111155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ECG Mean Heart Rate", + "decode": "ECG Mean Heart Rate", + "coding": { + "code": "C119259", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Interpretation", + "decode": "Interpretation", + "coding": { + "code": "C41255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intraventricular-Intraatrial Conduction", + "decode": "Intraventricular-Intraatrial Conduction", + "coding": { + "code": "C111238", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Pacemaker", + "decode": "Pacemaker", + "coding": { + "code": "C111285", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PR Interval, Aggregate", + "decode": "PQ Interval, Aggregate", + "coding": { + "code": "C117773", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS Axis", + "decode": "QRS Axis", + "coding": { + "code": "C118165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS Duration, Aggregate", + "decode": "QRS Duration, Aggregate", + "coding": { + "code": "C117779", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QT Interval, Aggregate", + "decode": "QT Interval, Aggregate", + "coding": { + "code": "C117783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTcB Interval, Aggregate", + "decode": "QTcB Interval, Aggregate", + "coding": { + "code": "C117784", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTcF Interval, Aggregate", + "decode": "QTcF Interval, Aggregate", + "coding": { + "code": "C117786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Rhythm Not Otherwise Specified", + "decode": "Rhythm Not Otherwise Specified", + "coding": { + "code": "C111307", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RR Interval, Aggregate", + "decode": "RR Interval, Aggregate", + "coding": { + "code": "C117791", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sinus Node Rhythms and Arrhythmias", + "decode": "Sinus Node Rhythms and Arrhythmias", + "coding": { + "code": "C111312", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Supraventricular Arrhythmias", + "decode": "Supraventricular Arrhythmias", + "coding": { + "code": "C111320", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Supraventricular Tachyarrhythmias", + "decode": "Supraventricular Tachyarrhythmias", + "coding": { + "code": "C111321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Technical Quality", + "decode": "Technical Quality", + "coding": { + "code": "C117807", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ventricular Arrhythmias", + "decode": "Ventricular Arrhythmias", + "coding": { + "code": "C111330", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ventricular Tachyarrhythmias", + "decode": "Ventricular Tachyarrhythmias", + "coding": { + "code": "C111331", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.EGSTRESC", + "name": "ECG Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71150", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGMETHOD", + "name": "ECG Test Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71151", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EVAL", + "name": "Evaluator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78735", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ADJUDICATION COMMITTEE", + "decode": "", + "coding": { + "code": "C78726", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INDEPENDENT ASSESSOR", + "decode": "", + "coding": { + "code": "C78720", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INVESTIGATOR", + "decode": "", + "coding": { + "code": "C25936", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VENDOR", + "decode": "", + "coding": { + "code": "C68608", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.FRM", + "name": "Dosage Form", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66726", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ROUTE", + "name": "Route of Administration Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66729", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTESTCD", + "name": "Laboratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C65047", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ALB", + "decode": "Albumin", + "coding": { + "code": "C64431", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ALP", + "decode": "Alkaline Phosphatase", + "coding": { + "code": "C64432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ALT", + "decode": "Alanine Aminotransferase", + "coding": { + "code": "C64433", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ANISO", + "decode": "Anisocytes", + "coding": { + "code": "C74797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AST", + "decode": "Aspartate Aminotransferase", + "coding": { + "code": "C64467", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BASO", + "decode": "Basophils", + "coding": { + "code": "C64470", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BICARB", + "decode": "Bicarbonate", + "coding": { + "code": "C74667", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BILI", + "decode": "Bilirubin", + "coding": { + "code": "C38037", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CA", + "decode": "Calcium", + "coding": { + "code": "C64488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHOL", + "decode": "Cholesterol", + "coding": { + "code": "C105586", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CL", + "decode": "Chloride", + "coding": { + "code": "C64495", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "COLOR", + "decode": "Color", + "coding": { + "code": "C64546", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CREAT", + "decode": "Creatinine", + "coding": { + "code": "C64547", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EOS", + "decode": "Eosinophils", + "coding": { + "code": "C64550", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GGT", + "decode": "Gamma Glutamyl Transferase", + "coding": { + "code": "C64847", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GLUC", + "decode": "Glucose", + "coding": { + "code": "C105585", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HBA1C", + "decode": "HbA1c", + "coding": { + "code": "C64849", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HBA1CHGB", + "decode": "Hemoglobin A1C/Hemoglobin", + "coding": { + "code": "C111207", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HCT", + "decode": "Erythrocyte Volume Fraction", + "coding": { + "code": "C64796", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HGB", + "decode": "Hemoglobin", + "coding": { + "code": "C64848", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "K", + "decode": "Potassium", + "coding": { + "code": "C64853", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "KETONES", + "decode": "Ketones", + "coding": { + "code": "C64854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MACROCY", + "decode": "Macrocytes", + "coding": { + "code": "C64821", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCH", + "decode": "Ery. Mean Corpuscular Hemoglobin", + "coding": { + "code": "C64797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCHC", + "decode": "Ery. Mean Corpuscular HGB Concentration", + "coding": { + "code": "C64798", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCV", + "decode": "Ery. Mean Corpuscular Volume", + "coding": { + "code": "C64799", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MICROCY", + "decode": "Microcytes", + "coding": { + "code": "C64822", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MONO", + "decode": "Monocytes", + "coding": { + "code": "C64823", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUT", + "decode": "Neutrophils", + "coding": { + "code": "C63321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUTB", + "decode": "Neutrophils Band Form", + "coding": { + "code": "C64830", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUTSG", + "decode": "Neutrophils, Segmented", + "coding": { + "code": "C81997", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NITRITE", + "decode": "Nitrite", + "coding": { + "code": "C64810", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OCCBLD", + "decode": "Occult Blood", + "coding": { + "code": "C74686", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PHOS", + "decode": "Inorganic Phosphate", + "coding": { + "code": "C64857", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PLAT", + "decode": "Platelets", + "coding": { + "code": "C51951", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POIKILO", + "decode": "Poikilocytes", + "coding": { + "code": "C79602", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POLYCHR", + "decode": "Polychromasia", + "coding": { + "code": "C64803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PROT", + "decode": "Protein", + "coding": { + "code": "C64858", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RBC", + "decode": "Erythrocytes", + "coding": { + "code": "C51946", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SODIUM", + "decode": "Sodium", + "coding": { + "code": "C64809", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPGRAV", + "decode": "Specific Gravity", + "coding": { + "code": "C64832", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T3", + "decode": "Total T3", + "coding": { + "code": "C74747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T3UP", + "decode": "T3RU", + "coding": { + "code": "C74748", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T4FR", + "decode": "Free T4", + "coding": { + "code": "C74786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T4FRIDX", + "decode": "Thyroxine, Free Index", + "coding": { + "code": "C170598", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TSH", + "decode": "Thyroid Stimulating Hormone", + "coding": { + "code": "C64813", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URATE", + "decode": "Urate", + "coding": { + "code": "C64814", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UREAN", + "decode": "Urea Nitrogen", + "coding": { + "code": "C125949", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UROBIL", + "decode": "Urobilinogen", + "coding": { + "code": "C64816", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VITB12", + "decode": "Cobalamin", + "coding": { + "code": "C64817", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VITB9", + "decode": "Folate", + "coding": { + "code": "C74676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "WBC", + "decode": "Leukocytes", + "coding": { + "code": "C51948", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LBTEST", + "name": "Laboratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67154", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Alanine Aminotransferase", + "decode": "Alanine Aminotransferase", + "coding": { + "code": "C64433", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Albumin", + "decode": "Albumin", + "coding": { + "code": "C64431", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Alkaline Phosphatase", + "decode": "Alkaline Phosphatase", + "coding": { + "code": "C64432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Anisocytes", + "decode": "Anisocytes", + "coding": { + "code": "C74797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Aspartate Aminotransferase", + "decode": "Aspartate Aminotransferase", + "coding": { + "code": "C64467", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Basophils", + "decode": "Basophils", + "coding": { + "code": "C64470", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Bicarbonate", + "decode": "Bicarbonate", + "coding": { + "code": "C74667", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Bilirubin", + "decode": "Bilirubin", + "coding": { + "code": "C38037", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Calcium", + "decode": "Calcium", + "coding": { + "code": "C64488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Chloride", + "decode": "Chloride", + "coding": { + "code": "C64495", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Cholesterol", + "decode": "Cholesterol", + "coding": { + "code": "C105586", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Color", + "decode": "Color", + "coding": { + "code": "C64546", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Creatinine", + "decode": "Creatinine", + "coding": { + "code": "C64547", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Eosinophils", + "decode": "Eosinophils", + "coding": { + "code": "C64550", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular Hemoglobin", + "decode": "Ery. Mean Corpuscular Hemoglobin", + "coding": { + "code": "C64797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular HGB Concentration", + "decode": "Ery. Mean Corpuscular HGB Concentration", + "coding": { + "code": "C64798", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular Volume", + "decode": "Ery. Mean Corpuscular Volume", + "coding": { + "code": "C64799", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Erythrocytes", + "decode": "Erythrocytes", + "coding": { + "code": "C51946", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Gamma Glutamyl Transferase", + "decode": "Gamma Glutamyl Transferase", + "coding": { + "code": "C64847", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Glucose", + "decode": "Glucose", + "coding": { + "code": "C105585", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hematocrit", + "decode": "Erythrocyte Volume Fraction", + "coding": { + "code": "C64796", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin A1C", + "decode": "HbA1c", + "coding": { + "code": "C64849", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin A1C/Hemoglobin", + "decode": "Hemoglobin A1C/Hemoglobin", + "coding": { + "code": "C111207", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin", + "decode": "Hemoglobin", + "coding": { + "code": "C64848", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ketones", + "decode": "Ketones", + "coding": { + "code": "C64854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Leukocytes", + "decode": "Leukocytes", + "coding": { + "code": "C51948", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Macrocytes", + "decode": "Macrocytes", + "coding": { + "code": "C64821", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Microcytes", + "decode": "Microcytes", + "coding": { + "code": "C64822", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Monocytes", + "decode": "Monocytes", + "coding": { + "code": "C64823", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils Band Form", + "decode": "Neutrophils Band Form", + "coding": { + "code": "C64830", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils", + "decode": "Neutrophils", + "coding": { + "code": "C63321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils, Segmented", + "decode": "Neutrophils, Segmented", + "coding": { + "code": "C81997", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Nitrite", + "decode": "Nitrite", + "coding": { + "code": "C64810", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Occult Blood", + "decode": "Occult Blood", + "coding": { + "code": "C74686", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Phosphate", + "decode": "Inorganic Phosphate", + "coding": { + "code": "C64857", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Platelets", + "decode": "Platelets", + "coding": { + "code": "C51951", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Poikilocytes", + "decode": "Poikilocytes", + "coding": { + "code": "C79602", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Polychromasia", + "decode": "Polychromasia", + "coding": { + "code": "C64803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Potassium", + "decode": "Potassium", + "coding": { + "code": "C64853", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Protein", + "decode": "Protein", + "coding": { + "code": "C64858", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sodium", + "decode": "Sodium", + "coding": { + "code": "C64809", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Specific Gravity", + "decode": "Specific Gravity", + "coding": { + "code": "C64832", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyrotropin", + "decode": "Thyroid Stimulating Hormone", + "coding": { + "code": "C64813", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyroxine, Free Index", + "decode": "Thyroxine, Free Index", + "coding": { + "code": "C170598", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyroxine, Free", + "decode": "Free T4", + "coding": { + "code": "C74786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Triiodothyronine Uptake", + "decode": "T3RU", + "coding": { + "code": "C74748", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Triiodothyronine", + "decode": "Total T3", + "coding": { + "code": "C74747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urate", + "decode": "Urate", + "coding": { + "code": "C64814", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urea Nitrogen", + "decode": "Urea Nitrogen", + "coding": { + "code": "C125949", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urobilinogen", + "decode": "Urobilinogen", + "coding": { + "code": "C64816", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Vitamin B12", + "decode": "Cobalamin", + "coding": { + "code": "C64817", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Vitamin B9", + "decode": "Folate", + "coding": { + "code": "C74676", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LBSTRESC", + "name": "Laboratory Test Standard Character Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C102580", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NRIND", + "name": "Reference Range Indicator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78736", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SPECTYPE", + "name": "Specimen Type", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78734", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "BLOOD", + "decode": "Peripheral Blood", + "coding": { + "code": "C12434", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ERYTHROCYTES", + "decode": "RBC", + "coding": { + "code": "C12521", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SERUM OR PLASMA", + "decode": "Ser/Plas", + "coding": { + "code": "C105706", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STOOL", + "decode": "Feces", + "coding": { + "code": "C13234", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URINE SEDIMENT", + "decode": "", + "coding": { + "code": "C158282", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URINE", + "decode": "", + "coding": { + "code": "C13283", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CEREBROSPINAL FLUID", + "decode": "CSF", + "coding": { + "code": "C12692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FLUID", + "decode": "", + "coding": { + "code": "C13236", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SERUM", + "decode": "Sera", + "coding": { + "code": "C13325", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SWABBED MATERIAL", + "decode": "", + "coding": { + "code": "C150895", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.METHOD", + "name": "Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C85492", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "DIPSTICK MEASUREMENT METHOD", + "decode": "", + "coding": { + "code": "C178142", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY", + "decode": "Chemiluminescent Magnetic Microparticle Immunoassay", + "coding": { + "code": "C172557", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FLUORESCENT IMMUNOASSAY", + "decode": "Fluorescent Antibody Assay", + "coding": { + "code": "C17370", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HEMAGGLUTINATION ASSAY", + "decode": "", + "coding": { + "code": "C130173", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IMMUNOBLOT", + "decode": "", + "coding": { + "code": "C17638", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "LINE PROBE ASSAY", + "decode": "LiPA", + "coding": { + "code": "C102656", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POLYMERASE CHAIN REACTION", + "decode": "PCR", + "coding": { + "code": "C17003", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RAPID IMMUNOASSAY", + "decode": "", + "coding": { + "code": "C178031", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.MBTESTCD", + "name": "Microbiology Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120527", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "TPADNA", + "decode": "Treponema pallidum DNA", + "coding": { + "code": "C198341", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TPLAB", + "decode": "" + } + ] + }, + { + "OID": "CL.MBTEST", + "name": "Microbiology Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120528", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Treponema pallidum DNA", + "decode": "Treponema pallidum DNA", + "coding": { + "code": "C198341", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.MBFTSDTL", + "name": "Microbiology Findings Test Details", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C174225", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "DETECTION", + "decode": "", + "coding": { + "code": "C174330", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DIR", + "name": "Directionality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99074", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "LOWER", + "decode": "", + "coding": { + "code": "C25309", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MIDLINE", + "decode": "", + "coding": { + "code": "C81170", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UPPER", + "decode": "", + "coding": { + "code": "C25355", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.AESEV", + "name": "Severity/Intensity Scale for Adverse Events", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66769", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ACN", + "name": "Action Taken with Study Treatment", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66767", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.OUT", + "name": "Outcome of Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66768", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TSPARMCD", + "name": "Trial Summary Parameter Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66738", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ADAPT", + "decode": "Adaptive Design", + "coding": { + "code": "C146995", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AGEMAX", + "decode": "Planned Maximum Age of Subjects", + "coding": { + "code": "C49694", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AGEMIN", + "decode": "Planned Minimum Age of Subjects", + "coding": { + "code": "C49693", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "COMPTRT", + "decode": "Comparative Treatment Name", + "coding": { + "code": "C68612", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CRMDUR", + "decode": "Confirmed Response Minimum Duration", + "coding": { + "code": "C98715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSE", + "decode": "Dose Level", + "coding": { + "code": "C25488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSFRQ", + "decode": "Dosing Frequency", + "coding": { + "code": "C89081", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSU", + "decode": "Dose Units", + "coding": { + "code": "C73558", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INDIC", + "decode": "Indication for Use", + "coding": { + "code": "C112038", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTMODEL", + "decode": "Intervention Model", + "coding": { + "code": "C98746", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTTYPE", + "decode": "Intervention Type", + "coding": { + "code": "C98747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NARMS", + "decode": "Planned Number of Arms", + "coding": { + "code": "C98771", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OBJPRIM", + "decode": "Study Primary Objective", + "coding": { + "code": "C85826", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OBJSEC", + "decode": "Study Secondary Objective", + "coding": { + "code": "C85827", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OUTMSPRI", + "decode": "Primary Outcome Measure", + "coding": { + "code": "C98772", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OUTMSSEC", + "decode": "Secondary Outcome Measure", + "coding": { + "code": "C98781", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PLANSUB", + "decode": "Anticipated Enrollment", + "coding": { + "code": "C49692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PTRTDUR", + "decode": "Planned Treatment Duration", + "coding": { + "code": "C139276", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ROUTE", + "decode": "Route of Administration", + "coding": { + "code": "C38114", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SEXPOP", + "decode": "Sex of Participants", + "coding": { + "code": "C49696", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPONSOR", + "decode": "Clinical Study Sponsor", + "coding": { + "code": "C70793", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STYPE", + "decode": "Study Type", + "coding": { + "code": "C142175", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TBLIND", + "decode": "Study Blinding Design", + "coding": { + "code": "C49658", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "THERAREA", + "decode": "Therapeutic Area", + "coding": { + "code": "C101302", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TINDTP", + "decode": "Trial Intent Type", + "coding": { + "code": "C49652", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TITLE", + "decode": "Official Study Title", + "coding": { + "code": "C49802", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TPHASE", + "decode": "Trial Phase", + "coding": { + "code": "C48281", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TRT", + "decode": "Investigational Interventional", + "coding": { + "code": "C41161", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TTYPE", + "decode": "Trial Scope", + "coding": { + "code": "C49660", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.TSPARM", + "name": "Trial Summary Parameter Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Adaptive Design", + "decode": "Adaptive Design", + "coding": { + "code": "C146995", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Clinical Study Sponsor", + "decode": "Clinical Study Sponsor", + "coding": { + "code": "C70793", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Comparative Treatment Name", + "decode": "Comparative Treatment Name", + "coding": { + "code": "C68612", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Confirmed Response Minimum Duration", + "decode": "Confirmed Response Minimum Duration", + "coding": { + "code": "C98715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dose per Administration", + "decode": "Dose Level", + "coding": { + "code": "C25488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dose Units", + "decode": "Dose Units", + "coding": { + "code": "C73558", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dosing Frequency", + "decode": "Dosing Frequency", + "coding": { + "code": "C89081", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intervention Model", + "decode": "Intervention Model", + "coding": { + "code": "C98746", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intervention Type", + "decode": "Intervention Type", + "coding": { + "code": "C98747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Investigational Therapy or Treatment", + "decode": "Investigational Interventional", + "coding": { + "code": "C41161", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Maximum Age of Subjects", + "decode": "Planned Maximum Age of Subjects", + "coding": { + "code": "C49694", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Minimum Age of Subjects", + "decode": "Planned Minimum Age of Subjects", + "coding": { + "code": "C49693", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Number of Arms", + "decode": "Planned Number of Arms", + "coding": { + "code": "C98771", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Number of Subjects", + "decode": "Anticipated Enrollment", + "coding": { + "code": "C49692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Treatment Duration", + "decode": "Planned Treatment Duration", + "coding": { + "code": "C139276", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Primary Outcome Measure", + "decode": "Primary Outcome Measure", + "coding": { + "code": "C98772", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Route of Administration", + "decode": "Route of Administration", + "coding": { + "code": "C38114", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Secondary Outcome Measure", + "decode": "Secondary Outcome Measure", + "coding": { + "code": "C98781", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sex of Participants", + "decode": "Sex of Participants", + "coding": { + "code": "C49696", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Study Type", + "decode": "Study Type", + "coding": { + "code": "C142175", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Therapeutic Area", + "decode": "Therapeutic Area", + "coding": { + "code": "C101302", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Blinding Schema", + "decode": "Study Blinding Design", + "coding": { + "code": "C49658", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Disease/Condition Indication", + "decode": "Indication for Use", + "coding": { + "code": "C112038", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Intent Type", + "decode": "Trial Intent Type", + "coding": { + "code": "C49652", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Phase Classification", + "decode": "Trial Phase", + "coding": { + "code": "C48281", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Primary Objective", + "decode": "Study Primary Objective", + "coding": { + "code": "C85826", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Secondary Objective", + "decode": "Study Secondary Objective", + "coding": { + "code": "C85827", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Title", + "decode": "Official Study Title", + "coding": { + "code": "C49802", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Type", + "decode": "Trial Scope", + "coding": { + "code": "C49660", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DICTNAM", + "name": "Dictionary Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66788", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.IECAT", + "name": "Category of Inclusion/Exclusion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66797", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.CNTMODE", + "name": "Mode of Subject Contact", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C171445", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "IN PERSON", + "decode": "In-Person", + "coding": { + "code": "C175574", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TELEPHONE CALL", + "decode": "", + "coding": { + "code": "C171537", + "codeSystem": "nci:ExtCodeID" + } + } + ] + } + ], + "methods": [], + "standards": [ + { + "OID": "STD.SDTMIG", + "name": "SDTMIG", + "type": "IG", + "version": "3.4", + "status": "FINAL" + }, + { + "OID": "STD.SDTMCT", + "name": "CDISC/NCI", + "type": "CT", + "version": "2025-03-28", + "status": "FINAL", + "publishingSet": "SDTM" + } + ], + "annotatedCRF": [], + "concepts": [], + "conceptProperties": [] +} \ No newline at end of file diff --git a/src/generators/define/itemGroups.py b/src/generators/define/itemGroups.py index a3e4275..835bb4c 100644 --- a/src/generators/define/itemGroups.py +++ b/src/generators/define/itemGroups.py @@ -6,6 +6,8 @@ import valueLevel as VL from constants import TRIAL_DESIGN_DOMAINS, NON_REPEATING_DOMAINS, DEFAULT_PURPOSE +MAX_SUBCLASS_DEPTH = 4 + class ItemGroups(define_object.DefineObject): """ create a Define-XML v2.1 ItemGroupDef element template """ @@ -51,23 +53,47 @@ def _generate_dataset(self, dataset, define_objects, lang, acrf): slices = dataset.get("slices") items.Items().create_define_objects(items_list, define_objects, lang, acrf, slice=slices) - # assumption: list of subclasses, but no nested subclasses - may need to revisit this for ADaM - if dataset.get("observationClass", {}).get("name", ""): - ds_class = dataset["observationClass"]["name"].upper().replace("-", " ") + observation_class = dataset.get("observationClass") or {} + if observation_class.get("name"): + ds_class = observation_class["name"].upper().replace("-", " ") itg.Class = DEFINE.Class(Name=ds_class) - sub_classes = dataset.get("observationClass").get("subClasses", []) - for sub_class in sub_classes: - sub_class_name = sub_class.get("name") - if sub_class_name.get("parentClass", ""): - itg.Class.SubClass.append(DEFINE.SubClass(Name=sub_class["name"], ParentClass=sub_class["parentClass"])) - else: - itg.Class.SubClass.append(DEFINE.SubClass(Name=sub_class["name"])) + self._append_subclasses( + itg.Class, + observation_class.get("subClasses") or [], + parent_name=None, + depth=1, + ) # default is Dataset-JSON .ndjson datasets - will be overridden in post-processing if is_xpt CL arg is True leaf = DEFINE.leaf(ID="LF." + dataset_name, href=dataset_name.lower() + ".ndjson") leaf.title = DEFINE.title(_content=dataset_name.lower() + ".ndjson") itg.leaf = leaf + def _append_subclasses(self, class_obj, sub_classes, parent_name, depth): + """ + Flatten a nested subClasses JSON tree into Class.SubClass siblings. + + Define-XML v2.1 represents nested SubClasses as flat siblings under def:Class + with the ParentClass attribute referencing the parent SubClass's Name. Depth + is capped at MAX_SUBCLASS_DEPTH; deeper levels are silently dropped. + """ + if depth > MAX_SUBCLASS_DEPTH: + return + for sub_class in sub_classes: + name = sub_class.get("name") + if not name: + continue + resolved_parent = sub_class.get("parentClass") or parent_name + if resolved_parent: + class_obj.SubClass.append( + DEFINE.SubClass(Name=name, ParentClass=resolved_parent) + ) + else: + class_obj.SubClass.append(DEFINE.SubClass(Name=name)) + nested = sub_class.get("subClasses") or [] + if nested: + self._append_subclasses(class_obj, nested, parent_name=name, depth=depth + 1) + def _create_itemgroupdef_object(self, obj): name = self.require_key(obj, "name", "ItemGroupDef") oid = self.generate_oid(["IG", name]) diff --git a/src/generators/define/items.py b/src/generators/define/items.py index 419caf7..9d99499 100644 --- a/src/generators/define/items.py +++ b/src/generators/define/items.py @@ -69,6 +69,7 @@ def _create_itemdef_object(self, obj, oid, slice): @staticmethod def _new_itemdef(attr: dict[str, Any]) -> Any: """Instantiate an ItemDef without triggering descriptor validation.""" + # TODO replace this with v0.2.0 odmlib permissive mode item = object.__new__(DEFINE.ItemDef) for key, value in attr.items(): item.__dict__[key] = value @@ -88,7 +89,23 @@ def _add_optional_itemdef_elements(self, item, obj, it_oid, slice): self._add_origin(item, obj) def _add_origin(self, item, obj): - origin_in = obj["origin"] + origins_in = obj["origin"] + if isinstance(origins_in, dict): + # Today's DDS shape: a single origin dict with item-level predecessor/pages siblings. + # Future shape: a list of origin dicts, each carrying its own predecessor/pages. + # Normalize today's shape by folding the item-level fields into the wrapped dict so + # the per-origin builder only ever reads from the origin dict. + wrapped = dict(origins_in) + if obj.get("predecessor") and "predecessor" not in wrapped: + wrapped["predecessor"] = obj["predecessor"] + if obj.get("pages") and "pages" not in wrapped: + wrapped["pages"] = obj["pages"] + origins_in = [wrapped] + + for origin_in in origins_in: + item.Origin.append(self._build_origin(origin_in)) + + def _build_origin(self, origin_in): origin_type = origin_in.get("type") origin_source = origin_in.get("source") attr: dict[str, Any] = {} @@ -108,17 +125,16 @@ def _add_origin(self, item, obj): dr.PDFPageRef.append(DEFINE.PDFPageRef(PageRefs="__PLACEHOLDER__", Type="PhysicalRef")) origin.DocumentRef.append(dr) - if obj.get("predecessor"): + if origin_in.get("predecessor"): origin.Description = DEFINE.Description() origin.Description.TranslatedText.append( - DEFINE.TranslatedText(_content=obj["predecessor"], lang=self.lang) + DEFINE.TranslatedText(_content=origin_in["predecessor"], lang=self.lang) ) - if obj.get("pages"): + if origin_in.get("pages"): dr = DEFINE.DocumentRef(leafID=self.acrf) - dr.PDFPageRef.append(DEFINE.PDFPageRef(PageRefs=obj["pages"], Type="PhysicalRef")) + dr.PDFPageRef.append(DEFINE.PDFPageRef(PageRefs=origin_in["pages"], Type="PhysicalRef")) origin.DocumentRef.append(dr) - - item.Origin.append(origin) + return origin @staticmethod def _add_optional_itemdef_attributes(attr, obj): @@ -131,6 +147,13 @@ def _add_optional_itemdef_attributes(attr, obj): attr["Length"] = "__PLACEHOLDER__" if obj.get("significantDigits"): attr["SignificantDigits"] = obj["significantDigits"] + elif obj.get("displayFormat") and obj.get("dataType") == "float": + # TODO work around issue 78 - missing significant digits - remove after USDM updated + length_str, sep, sig_str = str(obj["displayFormat"]).partition(".") + if sep and sig_str.isdigit(): + attr["SignificantDigits"] = int(sig_str) + if length_str.isdigit() and attr.get("Length") == "__PLACEHOLDER__": + attr["Length"] = int(length_str) if obj.get("displayFormat"): attr["DisplayFormat"] = obj["displayFormat"] if obj.get("comment"): diff --git a/src/generators/define/post_processing.py b/src/generators/define/post_processing.py index 79854f4..6cf9bba 100644 --- a/src/generators/define/post_processing.py +++ b/src/generators/define/post_processing.py @@ -36,8 +36,7 @@ def _add_derived_methods(self) -> None: Add methods to ItemDefs where the def:Origin Type="Derived". """ for item_def in self.define_objects['ItemDef']: - # assumes we're interested in the first origin; define.json defines origin as an object, not a list - if item_def.Origin and item_def.Origin[0].Type == 'Derived': + if any(getattr(o, "Type", None) == "Derived" for o in (item_def.Origin or [])): # generate the MethodOID method_oid = self._generate_method_oid(item_def.OID) # find the ItemRef and add a MethodOID attribute diff --git a/src/generators/define/tests/fixtures/define-360i.json b/src/generators/define/tests/fixtures/define-360i.json index 3810146..10bdd03 100644 --- a/src/generators/define/tests/fixtures/define-360i.json +++ b/src/generators/define/tests/fixtures/define-360i.json @@ -36635,7 +36635,7 @@ "decode": "Chemiluminescent Magnetic Microparticle Immunoassay", "coding": { "code": "C172557", - "codeSystem": "nci:ExtCodeID"Class + "codeSystem": "nci:ExtCodeID" } }, { diff --git a/src/generators/define/tests/fixtures/define-360i.xml b/src/generators/define/tests/fixtures/define-360i.xml index e6cb955..fc15413 100644 --- a/src/generators/define/tests/fixtures/define-360i.xml +++ b/src/generators/define/tests/fixtures/define-360i.xml @@ -1,2 +1,8491 @@ -LZZT - NEWSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's DiseaseLZZT - NEWEDULEVELEDUYRNUMEDUYRNUMTEMPAXILLAEARFOREHEADORAL CAVITYRECTUMWEIGHTHEIGHTPULSEPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYCEREBRAL ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYRADIAL ARTERYLEFTRIGHTRESPBMISYSBPPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYFINGERRADIAL ARTERYLEFTRIGHTDIABPPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYFINGERRADIAL ARTERYLEFTRIGHTHRPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYCEREBRAL ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYRADIAL ARTERYLEFTRIGHTTEMPAXILLAEARFOREHEADORAL CAVITYRECTUMWEIGHTHEIGHTPULSEPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYCEREBRAL ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYRADIAL ARTERYLEFTRIGHTRESPBMISYSBPPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYFINGERRADIAL ARTERYLEFTRIGHTDIABPPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYFINGERRADIAL ARTERYLEFTRIGHTHRPRONESEMI-RECUMBENTSITTINGSTANDINGSUPINEBRACHIAL ARTERYCAROTID ARTERYCEREBRAL ARTERYDORSALIS PEDIS ARTERYFEMORAL ARTERYRADIAL ARTERYLEFTRIGHTINTPADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORAVCONDADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORAXISVOLTADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORCHYPTENLADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORTECHQUALADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORIVTIACDADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORPACEMAKRADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORRHYNOSADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORSNRARRYADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORSPRARRYADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORSPRTARRYADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORVTARRYADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORVTTARRYADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORPRAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQRSAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTCBAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTCFAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORRRAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDOREGHRMNADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQRS_AXISADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORPRAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQRSAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTCBAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQTCFAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORRRAGADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDOREGHRMNADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORQRS_AXISADJUDICATION COMMITTEEINDEPENDENT ASSESSORINVESTIGATORVENDORHGBBLOODDIPSTICK MEASUREMENT METHODHCTBLOODRBCBLOODMCHERYTHROCYTESMCHCERYTHROCYTESMCVERYTHROCYTESWBCBLOODNEUTSGBLOODNEUTBBLOODNEUTBLOODMONOBLOODEOSBLOODBASOBLOODPLATBLOODMICROCYURINE SEDIMENTMACROCYURINE SEDIMENTANISOBLOODPOIKILOBLOODPOLYCHRBLOODALTSERUM OR PLASMAALBURINEALPSERUM OR PLASMAASTSERUM OR PLASMACREATURINEKURINESODIUMURINEUREANSERUM OR PLASMABICARBBLOODCLSERUM OR PLASMABILIURINEGGTSERUM OR PLASMAURATESERUM OR PLASMAPHOSSERUM OR PLASMACASERUM OR PLASMAGLUCURINEPROTURINECHOLSERUM OR PLASMAT3UPSERUM OR PLASMAT3SERUM OR PLASMAT4FRSERUM OR PLASMAT4FRIDXSERUM OR PLASMATSHSERUM OR PLASMAVITB9SERUM OR PLASMAVITB12SERUM OR PLASMACOLORURINESPGRAVURINEKETONESURINEUROBILURINEOCCBLDSTOOLNITRITEURINEHBA1CBLOODHBA1CHGBBLOODHGBBLOODDIPSTICK MEASUREMENT METHODHCTBLOODRBCBLOODMCHERYTHROCYTESMCHCERYTHROCYTESMCVERYTHROCYTESWBCBLOODNEUTSGBLOODNEUTBBLOODNEUTBLOODMONOBLOODEOSBLOODBASOBLOODPLATBLOODALTSERUM OR PLASMAALPSERUM OR PLASMAASTSERUM OR PLASMACREATURINEKURINESODIUMURINEUREANSERUM OR PLASMABICARBBLOODCLSERUM OR PLASMAGGTSERUM OR PLASMAURATESERUM OR PLASMAPHOSSERUM OR PLASMACASERUM OR PLASMACHOLSERUM OR PLASMAT3UPSERUM OR PLASMAT3SERUM OR PLASMAT4FRSERUM OR PLASMAT4FRIDXSERUM OR PLASMATSHSERUM OR PLASMAVITB9SERUM OR PLASMAVITB12SERUM OR PLASMAUROBILURINEHBA1CBLOODHBA1CHGBBLOODTPLABDETECTIONSERUMFLUORESCENT IMMUNOASSAYHEMAGGLUTINATION ASSAYCHEMILUMINESCENT MICROPARTICLE IMMUNOASSAYPOLYMERASE CHAIN REACTIONIMMUNOBLOTRAPID IMMUNOASSAYTPADNADETECTIONBLOODCEREBROSPINAL FLUIDFLUIDSWABBED MATERIALURINELINE PROBE ASSAYADAPTAGEMINAGEMAXCOMPTRTCRMDURDOSEDOSFRQDOSUINDICINTMODELINTTYPENARMSOBJPRIMOBJSECOUTMSPRIOUTMSSECPLANSUBPTRTDURROUTESEXPOPSPONSORSTYPETBLINDTHERAREATINDTPTITLETPHASETRTTTYPEIN01IN02IN03IN04IN05IN06IN07IN08EX01EX02EX03EX04EX05EX06EX07EX08EX09EX10EX11EX12EX13EX14EX15EX16EX17EX18EX19EX20EX21EX22EX23Dispositionds.ndjsonDemographicsdm.ndjsonSubject Characteristicssc.ndjsonMedical Historymh.ndjsonSubstance Usesu.ndjsonProcedurespr.ndjsonVital Signsvs.ndjsonECG Test Resultseg.ndjsonConcomitant/Prior Medicationscm.ndjsonLaboratory Test Resultslb.ndjsonMicrobiology Specimenmb.ndjsonExposure as Collectedec.ndjsonAdverse Eventsae.ndjsonTrial Summaryts.ndjsonTrial Armsta.ndjsonTrial Elementste.ndjsonTrial Inclusion/Exclusion Criteriati.ndjsonTrial Visitstv.ndjsonSubject Visitssv.ndjsonInclusion/Exclusion Criteria Not Metie.ndjsonSubject Elementsse.ndjsonStudy IdentifierDomain AbbreviationUnique Subject IdentifierSequence NumberReported Term for the Disposition EventStandardized Disposition TermCategory for Disposition EventSubcategory for Disposition EventStart Date/Time of Disposition EventStudy Day of Start of Disposition EventStudy IdentifierDomain AbbreviationUnique Subject IdentifierSubject Identifier for the StudySubject Reference Start Date/TimeSubject Reference End Date/TimeDate/Time of First Study TreatmentDate/Time of Last Study TreatmentDate/Time of Informed ConsentDate/Time of End of ParticipationDate/Time of DeathSubject Death FlagStudy Site IdentifierAgeAge UnitsSexRaceEthnicityPlanned Arm CodeDescription of Planned ArmActual Arm CodeDescription of Actual ArmReason Arm and/or Actual Arm is NullDescription of Unplanned Actual ArmCountryDate/Time of CollectionStudy IdentifierDomain AbbreviationUnique Subject IdentifierSequence NumberSubject Characteristic Short NameSubject CharacteristicResult or Finding in Original UnitsOriginal UnitsCharacter Result/Finding in Std FormatNumeric Result/Finding in Standard UnitsStandard UnitsDate/Time of CollectionStudy IdentifierDomain AbbreviationUnique Subject IdentifierSequence NumberReported Term for the Medical HistoryDictionary-Derived TermMedical History Event Pre-SpecifiedMedical History OccurrenceEnd Relative to Reference PeriodEnd Relative to Reference Time PointEnd Reference Time PointStudy IdentifierDomain AbbreviationUnique Subject IdentifierSequence NumberReported Name of SubstanceCategory for Substance UseSubcategory for Substance UseSU Pre-SpecifiedSU OccurrenceSubstance Use ConsumptionSubstance Use Consumption TextConsumption UnitsUse Frequency Per IntervalStart Date/Time of Substance UseEnd Date/Time of Substance UseDuration of Substance UseStart Relative to Reference PeriodEnd Relative to Reference PeriodStart Relative to Reference Time PointStart Reference Time PointEnd Relative to Reference Time PointEnd Reference Time PointStudy IdentifierDomain AbbreviationUnique 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Mean Corpuscular Volume + + + + + + Microcytes + + + + + + Monocytes + + + + + + Neutrophils + + + + + + Neutrophils Band Form + + + + + + Neutrophils, Segmented + + + + + + Nitrite + + + + + + Occult Blood + + + + + + Inorganic Phosphate + + + + + + Platelets + + + + + + Poikilocytes + + + + + + Polychromasia + + + + + + Protein + + + + + + Erythrocytes + + + + + + Sodium + + + + + + Specific Gravity + + + + + + Total T3 + + + + + + T3RU + + + + + + Free T4 + + + + + + Thyroxine, Free Index + + + + + + Thyroid Stimulating Hormone + + + + + + Urate + + + + + + Urea Nitrogen + + + + + + Urobilinogen + + + + + + Cobalamin + + + + + + Folate + + + + + + Leukocytes + + + + + + + + + Alanine Aminotransferase + + + + + + Albumin + + + + + + Alkaline Phosphatase + + + + + + Anisocytes + + + + + + Aspartate Aminotransferase + + + + + + Basophils + + + + + + Bicarbonate + + + + + + Bilirubin + + + + + + Calcium + + + + + + Chloride + + + + + + Cholesterol + + + + + + Color + + + + + + Creatinine + + + + + + Eosinophils + + + + + + Ery. Mean Corpuscular Hemoglobin + + + + + + Ery. Mean Corpuscular HGB Concentration + + + + + + Ery. Mean Corpuscular Volume + + + + + + Erythrocytes + + + + + + Gamma Glutamyl Transferase + + + + + + Glucose + + + + + + Erythrocyte Volume Fraction + + + + + + HbA1c + + + + + + Hemoglobin A1C/Hemoglobin + + + + + + Hemoglobin + + + + + + Ketones + + + + + + Leukocytes + + + + + + Macrocytes + + + + + + Microcytes + + + + + + Monocytes + + + + + + Neutrophils Band Form + + + + + + Neutrophils + + + + + + Neutrophils, Segmented + + + + + + Nitrite + + + + + + Occult Blood + + + + + + Inorganic Phosphate + + + + + + Platelets + + + + + + Poikilocytes + + + + + + Polychromasia + + + + + + Potassium + + + + + + Protein + + + + + + Sodium + + + + + + Specific Gravity + + + + + + Thyroid Stimulating Hormone + + + + + + Thyroxine, Free Index + + + + + + Free T4 + + + + + + T3RU + + + + + + Total T3 + + + + + + Urate + + + + + + Urea Nitrogen + + + + + + Urobilinogen + + + + + + Cobalamin + + + + + + Folate + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + Peripheral Blood + + + + + + RBC + + + + + + Ser/Plas + + + + + + Feces + + + + + + URINE SEDIMENT + + + + + + URINE + + + + + + CSF + + + + + + FLUID + + + + + + Sera + + + + + + SWABBED MATERIAL + + + + + + + + + DIPSTICK MEASUREMENT METHOD + + + + + + Chemiluminescent Magnetic Microparticle Immunoassay + + + + + + + Fluorescent Antibody Assay + + + + + + HEMAGGLUTINATION ASSAY + + + + + + IMMUNOBLOT + + + + + + LiPA + + + + + + PCR + + + + + + RAPID IMMUNOASSAY + + + + + + + + + Treponema pallidum DNA + + + + + + TPLAB + + + + + + + + + Treponema pallidum DNA + + + + + + + + + DETECTION + + + + + + + + + LOWER + + + + + + MIDLINE + + + + + + UPPER + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + Adaptive Design + + + + + + Planned Maximum Age of Subjects + + + + + + Planned Minimum Age of Subjects + + + + + + Comparative Treatment Name + + + + + + Confirmed Response Minimum Duration + + + + + + Dose Level + + + + + + Dosing Frequency + + + + + + Dose Units + + + + + + Indication for Use + + + + + + Intervention Model + + + + + + Intervention Type + + + + + + Planned Number of Arms + + + + + + Study Primary Objective + + + + + + Study Secondary Objective + + + + + + Primary Outcome Measure + + + + + + Secondary Outcome Measure + + + + + + Anticipated Enrollment + + + + + + Planned Treatment Duration + + + + + + Route of Administration + + + + + + Sex of Participants + + + + + + Clinical Study Sponsor + + + + + + Study Type + + + + + + Study Blinding Design + + + + + + Therapeutic Area + + + + + + Trial Intent Type + + + + + + Official Study Title + + + + + + Trial Phase + + + + + + Investigational Interventional + + + + + + Trial Scope + + + + + + + + + Adaptive Design + + + + + + Clinical Study Sponsor + + + + + + Comparative Treatment Name + + + + + + Confirmed Response Minimum Duration + + + + + + Dose Level + + + + + + Dose Units + + + + + + Dosing Frequency + + + + + + Intervention Model + + + + + + Intervention Type + + + + + + Investigational Interventional + + + + + + Planned Maximum Age of Subjects + + + + + + Planned Minimum Age of Subjects + + + + + + Planned Number of Arms + + + + + + Anticipated Enrollment + + + + + + Planned Treatment Duration + + + + + + Primary Outcome Measure + + + + + + Route of Administration + + + + + + Secondary Outcome Measure + + + + + + Sex of Participants + + + + + + Study Type + + + + + + Therapeutic Area + + + + + + Study Blinding Design + + + + + + Indication for Use + + + + + + Trial Intent Type + + + + + + Trial Phase + + + + + + Study Primary Objective + + + + + + Study Secondary Objective + + + + + + Official Study Title + + + + + + Trial Scope + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + __PLACEHOLDER__ + + + + + + + + + In-Person + + + + + + TELEPHONE CALL + + + + + + + + __PLACEHOLDER__ for derivation of VSORRES BMI + + + + Annotated CRF + + + + \ No newline at end of file diff --git a/src/generators/define/tests/test_itemdef_attributes.py b/src/generators/define/tests/test_itemdef_attributes.py new file mode 100644 index 0000000..887653d --- /dev/null +++ b/src/generators/define/tests/test_itemdef_attributes.py @@ -0,0 +1,76 @@ +""" +Unit tests for Items._add_optional_itemdef_attributes, focused on the +displayFormat -> SignificantDigits/Length fallback (the issue-78 workaround). + +The fallback parses obj['displayFormat'] (e.g. "8.3") into a Length / +SignificantDigits pair when the study JSON omits them. The hardened version must: + * never raise when the format lacks exactly one dot (the old split(".") + unpack raised ValueError for "8", "1.2.3", etc.), and + * yield ints, matching the type of values that arrive straight from the JSON + (the old code left the derived values as strings). +""" +import pytest + + +@pytest.fixture +def add_attrs(): + import items + return items.Items._add_optional_itemdef_attributes + + +class TestExplicitValuesWin: + def test_explicit_significant_digits_preserved_as_int(self, add_attrs): + # An explicit significantDigits short-circuits the displayFormat fallback. + attr = {} + add_attrs(attr, {"significantDigits": 2, "dataType": "float", "displayFormat": "8.3"}) + assert attr["SignificantDigits"] == 2 + assert isinstance(attr["SignificantDigits"], int) + + def test_explicit_length_not_overridden_by_displayformat(self, add_attrs): + attr = {} + add_attrs(attr, {"dataType": "float", "length": 10, "displayFormat": "8.3"}) + assert attr["Length"] == 10 # explicit length wins + assert attr["SignificantDigits"] == 3 # sig digits still derived from format + assert isinstance(attr["SignificantDigits"], int) + + +class TestDisplayFormatFallback: + def test_float_displayformat_yields_int_significant_digits_and_length(self, add_attrs): + attr = {} + add_attrs(attr, {"dataType": "float", "displayFormat": "8.3"}) + # Core regression: derived values must be ints, not the strings the old + # split(".") branch produced. + assert attr["SignificantDigits"] == 3 + assert isinstance(attr["SignificantDigits"], int) + assert attr["Length"] == 8 + assert isinstance(attr["Length"], int) + + def test_displayformat_without_dot_does_not_raise(self, add_attrs): + # "8" has no dot; old split(".") -> single element -> ValueError on unpack. + attr = {} + add_attrs(attr, {"dataType": "float", "displayFormat": "8"}) + assert "SignificantDigits" not in attr + # The whole-number portion is still recovered into the placeholder slot. + assert attr["Length"] == 8 + assert isinstance(attr["Length"], int) + + def test_displayformat_with_multiple_dots_does_not_raise(self, add_attrs): + # "1.2.3" -> old split(".") -> three elements -> ValueError on unpack. + attr = {} + add_attrs(attr, {"dataType": "float", "displayFormat": "1.2.3"}) + # "2.3" is not a pure digit string, so no SignificantDigits is derived. + assert "SignificantDigits" not in attr + assert attr["Length"] == 1 + + def test_non_numeric_displayformat_leaves_placeholder(self, add_attrs): + attr = {} + add_attrs(attr, {"dataType": "float", "displayFormat": "DATE9."}) + assert "SignificantDigits" not in attr + assert attr["Length"] == "__PLACEHOLDER__" # nothing numeric to recover + assert attr["DisplayFormat"] == "DATE9." + + def test_fallback_only_applies_to_float_datatype(self, add_attrs): + attr = {} + add_attrs(attr, {"dataType": "text", "displayFormat": "8.3"}) + assert "SignificantDigits" not in attr + assert attr["DisplayFormat"] == "8.3" diff --git a/src/generators/define/tests/test_itemgroups_subclasses.py b/src/generators/define/tests/test_itemgroups_subclasses.py new file mode 100644 index 0000000..f236ace --- /dev/null +++ b/src/generators/define/tests/test_itemgroups_subclasses.py @@ -0,0 +1,314 @@ +""" +Tests for nested def:SubClass support in itemGroups.ItemGroups. + +Define-XML v2.1 represents nested SubClasses as flat siblings under def:Class +with the ParentClass attribute referencing the parent SubClass's Name. These +tests verify that the JSON subClasses tree is flattened correctly and that +nesting is capped at MAX_SUBCLASS_DEPTH levels under Class. +""" +import json +import xml.etree.ElementTree as ET + +import pytest +from odmlib.define_2_1 import model as DEFINE + + +@pytest.fixture +def item_groups(): + import itemGroups + return itemGroups.ItemGroups() + + +@pytest.fixture +def fresh_class(): + return DEFINE.Class(Name="FINDINGS") + + +def _names_and_parents(class_obj): + return [(sc.Name, getattr(sc, "ParentClass", None)) for sc in class_obj.SubClass] + + +class TestAppendSubclasses: + """Unit tests for the recursive flattener.""" + + def test_single_subclass_no_parent(self, item_groups, fresh_class): + item_groups._append_subclasses( + fresh_class, + [{"name": "LABORATORY"}], + parent_name=None, + depth=1, + ) + assert _names_and_parents(fresh_class) == [("LABORATORY", None)] + + def test_two_level_nesting_assigns_parent(self, item_groups, fresh_class): + item_groups._append_subclasses( + fresh_class, + [{"name": "LAB", "subClasses": [{"name": "CHEM"}]}], + parent_name=None, + depth=1, + ) + assert _names_and_parents(fresh_class) == [ + ("LAB", None), + ("CHEM", "LAB"), + ] + + def test_four_level_chain_fully_emitted(self, item_groups, fresh_class): + tree = [ + { + "name": "L1", + "subClasses": [ + { + "name": "L2", + "subClasses": [ + { + "name": "L3", + "subClasses": [{"name": "L4"}], + } + ], + } + ], + } + ] + item_groups._append_subclasses(fresh_class, tree, parent_name=None, depth=1) + assert _names_and_parents(fresh_class) == [ + ("L1", None), + ("L2", "L1"), + ("L3", "L2"), + ("L4", "L3"), + ] + + def test_fifth_level_is_dropped(self, item_groups, fresh_class): + tree = [ + { + "name": "L1", + "subClasses": [ + { + "name": "L2", + "subClasses": [ + { + "name": "L3", + "subClasses": [ + { + "name": "L4", + "subClasses": [{"name": "L5_dropped"}], + } + ], + } + ], + } + ], + } + ] + item_groups._append_subclasses(fresh_class, tree, parent_name=None, depth=1) + emitted = _names_and_parents(fresh_class) + assert ("L5_dropped", "L4") not in emitted + assert [name for name, _ in emitted] == ["L1", "L2", "L3", "L4"] + + def test_explicit_parent_overrides_walked_parent(self, item_groups, fresh_class): + tree = [ + { + "name": "LAB", + "subClasses": [ + {"name": "CHEM", "parentClass": "EXPLICIT_PARENT"}, + ], + } + ] + item_groups._append_subclasses(fresh_class, tree, parent_name=None, depth=1) + assert _names_and_parents(fresh_class) == [ + ("LAB", None), + ("CHEM", "EXPLICIT_PARENT"), + ] + + def test_empty_and_missing_subclasses_are_safe(self, item_groups, fresh_class): + item_groups._append_subclasses(fresh_class, [], parent_name=None, depth=1) + assert _names_and_parents(fresh_class) == [] + item_groups._append_subclasses( + fresh_class, + [{"name": "ONLY"}, {"name": "NEXT", "subClasses": None}], + parent_name=None, + depth=1, + ) + assert _names_and_parents(fresh_class) == [("ONLY", None), ("NEXT", None)] + + def test_entry_missing_name_is_skipped(self, item_groups, fresh_class): + item_groups._append_subclasses( + fresh_class, + [{"name": "A"}, {"parentClass": "A"}, {"name": "B"}], + parent_name=None, + depth=1, + ) + assert _names_and_parents(fresh_class) == [("A", None), ("B", None)] + + +class TestGenerateDatasetIntegration: + """Exercise observationClass handling through _generate_dataset.""" + + def _make_define_objects(self): + return { + "ItemGroupDef": [], + "ItemDef": [], + "ValueListDef": [], + "WhereClauseDef": [], + "CodeList": [], + "MethodDef": [], + "CommentDef": [], + "leaf": [], + } + + def _minimal_dataset(self, observation_class=None): + dataset = { + "name": "AE", + "description": "Adverse Events", + "structure": "One record per adverse event per subject", + "items": [ + { + "OID": "IT.AE.STUDYID", + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "mandatory": True, + } + ], + } + if observation_class is not None: + dataset["observationClass"] = observation_class + return dataset + + def test_nested_subclasses_emit_flat_siblings(self, item_groups): + item_groups.lang = "en" + define_objects = self._make_define_objects() + dataset = self._minimal_dataset( + observation_class={ + "name": "Findings", + "subClasses": [ + { + "name": "LAB", + "subClasses": [{"name": "CHEM"}], + } + ], + } + ) + item_groups._generate_dataset(dataset, define_objects, "en", "LF.acrf") + itg = define_objects["ItemGroupDef"][0] + assert itg.Class.Name == "FINDINGS" + assert _names_and_parents(itg.Class) == [ + ("LAB", None), + ("CHEM", "LAB"), + ] + + def test_observation_class_without_subclasses(self, item_groups): + item_groups.lang = "en" + define_objects = self._make_define_objects() + dataset = self._minimal_dataset(observation_class={"name": "Events"}) + item_groups._generate_dataset(dataset, define_objects, "en", "LF.acrf") + itg = define_objects["ItemGroupDef"][0] + assert itg.Class.Name == "EVENTS" + assert itg.Class.SubClass == [] + + def test_no_observation_class_emits_no_class(self, item_groups): + item_groups.lang = "en" + define_objects = self._make_define_objects() + dataset = self._minimal_dataset(observation_class=None) + item_groups._generate_dataset(dataset, define_objects, "en", "LF.acrf") + itg = define_objects["ItemGroupDef"][0] + assert itg.Class is None + + +class TestEndToEndGenerator: + """Run the full generator pipeline with nested subClasses in the DDS JSON.""" + + def _minimal_dds(self): + return { + "OID": "MDV.NESTED", + "name": "MDV NESTED", + "description": "Nested SubClass smoke test", + "fileOID": "ODM.NESTED", + "creationDateTime": "2026-06-16T00:00:00+00:00", + "odmVersion": "1.3.2", + "fileType": "Snapshot", + "originator": "test", + "context": "Other", + "defineVersion": "2.1.0", + "studyOID": "ODM.NESTED.Study", + "studyName": "Nested Study", + "studyDescription": "Nested SubClass smoke test", + "protocolName": "NESTED", + "itemGroups": [ + { + "OID": "IG.AE", + "name": "AE", + "description": "Adverse Events", + "domain": "AE", + "purpose": "Tabulation", + "structure": "One record per adverse event per subject", + "observationClass": { + "name": "Findings", + "subClasses": [ + { + "name": "LAB", + "subClasses": [ + { + "name": "CHEM", + "subClasses": [ + { + "name": "ALK", + "subClasses": [ + { + "name": "L4", + "subClasses": [ + {"name": "DROPPED"} + ], + } + ], + } + ], + } + ], + } + ], + }, + "items": [ + { + "OID": "IT.AE.STUDYID", + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "mandatory": True, + } + ], + } + ], + } + + def test_pipeline_emits_flattened_subclasses(self, temp_output_dir): + from define_generator import DefineGenerator + + dds_path = temp_output_dir / "nested_subclasses.json" + with open(dds_path, "w") as f: + json.dump(self._minimal_dds(), f) + output_xml = temp_output_dir / "nested_subclasses.xml" + + dg = DefineGenerator( + dds_file=str(dds_path), + define_file=str(output_xml), + log_level="WARNING", + ) + dg.create() + + assert output_xml.exists() + tree = ET.parse(output_xml) + ns = {"def": "http://www.cdisc.org/ns/def/v2.1"} + class_elems = tree.getroot().findall(".//def:Class", ns) + assert len(class_elems) == 1 + class_elem = class_elems[0] + assert class_elem.get("Name") == "FINDINGS" + sub_elems = class_elem.findall("def:SubClass", ns) + assert [(sc.get("Name"), sc.get("ParentClass")) for sc in sub_elems] == [ + ("LAB", None), + ("CHEM", "LAB"), + ("ALK", "CHEM"), + ("L4", "ALK"), + ] + assert all(sc.get("Name") != "DROPPED" for sc in sub_elems) diff --git a/src/generators/define/tests/test_origin_shapes.py b/src/generators/define/tests/test_origin_shapes.py new file mode 100644 index 0000000..8d7f275 --- /dev/null +++ b/src/generators/define/tests/test_origin_shapes.py @@ -0,0 +1,232 @@ +""" +Tests for ItemDef Origin generation under both the current (dict) and future +(list-of-dicts) shapes of `origin` in the DDS JSON. +""" +import pytest + + +@pytest.fixture +def items_instance(): + import items + inst = items.Items() + inst.lang = "en" + inst.acrf = "LF.ACRF" + return inst + + +def _new_itemdef(): + """Mirror the descriptor-bypass pattern used in Items._create_itemdef_object.""" + from odmlib.define_2_1 import model as DEFINE + item = object.__new__(DEFINE.ItemDef) + item.__dict__["Origin"] = [] + return item + + +class TestOriginDictShape: + """Today's shape: obj['origin'] is a single dict, predecessor/pages live on obj.""" + + def test_single_origin_dict_produces_one_origin(self, items_instance): + item = _new_itemdef() + obj = {"origin": {"type": "Collected", "source": "Investigator"}} + items_instance._add_origin(item, obj) + assert len(item.Origin) == 1 + assert item.Origin[0].Type == "Collected" + assert item.Origin[0].Source == "Investigator" + + def test_collected_investigator_attaches_acrf_documentref(self, items_instance): + item = _new_itemdef() + obj = {"origin": {"type": "Collected", "source": "Investigator"}} + items_instance._add_origin(item, obj) + assert len(item.Origin[0].DocumentRef) == 1 + assert item.Origin[0].DocumentRef[0].leafID == "LF.ACRF" + + def test_item_level_predecessor_folded_into_wrapped_origin(self, items_instance): + item = _new_itemdef() + obj = { + "origin": {"type": "Predecessor"}, + "predecessor": "DM.USUBJID", + } + items_instance._add_origin(item, obj) + assert item.Origin[0].Description.TranslatedText[0]._content == "DM.USUBJID" + + def test_item_level_pages_folded_into_wrapped_origin(self, items_instance): + item = _new_itemdef() + obj = { + "origin": {"type": "Collected", "source": "Investigator"}, + "pages": "5-7", + } + items_instance._add_origin(item, obj) + page_refs = [ + pr for dr in item.Origin[0].DocumentRef for pr in dr.PDFPageRef + if pr.PageRefs == "5-7" + ] + assert page_refs + + +class TestOriginDictFolding: + """Edge cases in folding item-level predecessor/pages into the single dict shape.""" + + def test_predecessor_and_pages_folded_together(self, items_instance): + item = _new_itemdef() + obj = { + "origin": {"type": "Collected", "source": "Investigator"}, + "predecessor": "DM.USUBJID", + "pages": "5-7", + } + items_instance._add_origin(item, obj) + assert item.Origin[0].Description.TranslatedText[0]._content == "DM.USUBJID" + page_refs = [ + pr.PageRefs for dr in item.Origin[0].DocumentRef for pr in dr.PDFPageRef + ] + assert "5-7" in page_refs + + def test_origin_own_predecessor_wins_over_item_level(self, items_instance): + # The wrapped dict already carries a predecessor, so the item-level sibling + # must NOT clobber it ("predecessor not in wrapped" guard). + item = _new_itemdef() + obj = { + "origin": {"type": "Predecessor", "predecessor": "ORIGIN.LEVEL"}, + "predecessor": "ITEM.LEVEL", + } + items_instance._add_origin(item, obj) + assert item.Origin[0].Description.TranslatedText[0]._content == "ORIGIN.LEVEL" + + def test_origin_own_pages_wins_over_item_level(self, items_instance): + item = _new_itemdef() + obj = { + "origin": {"type": "Collected", "source": "Investigator", "pages": "99"}, + "pages": "5-7", + } + items_instance._add_origin(item, obj) + page_refs = [ + pr.PageRefs for dr in item.Origin[0].DocumentRef for pr in dr.PDFPageRef + ] + assert "99" in page_refs + assert "5-7" not in page_refs + + +class TestOriginListShape: + """Future shape: obj['origin'] is a list of origin dicts, each self-contained.""" + + def test_single_element_list_equivalent_to_dict(self, items_instance): + item = _new_itemdef() + obj = {"origin": [{"type": "Collected", "source": "Investigator"}]} + items_instance._add_origin(item, obj) + assert len(item.Origin) == 1 + assert item.Origin[0].Type == "Collected" + assert item.Origin[0].Source == "Investigator" + + def test_empty_list_produces_no_origins(self, items_instance): + item = _new_itemdef() + items_instance._add_origin(item, {"origin": []}) + assert item.Origin == [] + + def test_item_level_predecessor_not_folded_into_list_shape(self, items_instance): + # Folding is intentionally dict-shape only. In the list shape each origin is + # self-contained, so an item-level predecessor sibling must be ignored. + item = _new_itemdef() + obj = { + "origin": [{"type": "Predecessor"}], + "predecessor": "ITEM.LEVEL", + } + items_instance._add_origin(item, obj) + # No predecessor text should have been emitted for the origin. + desc = getattr(item.Origin[0], "Description", None) + assert desc is None or desc.TranslatedText == [] + + def test_item_level_pages_not_folded_into_list_shape(self, items_instance): + item = _new_itemdef() + obj = { + "origin": [{"type": "Predecessor"}], + "pages": "5-7", + } + items_instance._add_origin(item, obj) + page_refs = [ + pr.PageRefs for dr in item.Origin[0].DocumentRef for pr in dr.PDFPageRef + ] + assert "5-7" not in page_refs + + def test_multiple_origins_produce_multiple_elements(self, items_instance): + item = _new_itemdef() + obj = { + "origin": [ + {"type": "Derived"}, + {"type": "Predecessor", "predecessor": "DM.USUBJID"}, + ] + } + items_instance._add_origin(item, obj) + assert len(item.Origin) == 2 + assert item.Origin[0].Type == "Derived" + assert item.Origin[1].Type == "Predecessor" + assert item.Origin[1].Description.TranslatedText[0]._content == "DM.USUBJID" + + def test_per_origin_pages_in_list_shape(self, items_instance): + item = _new_itemdef() + obj = { + "origin": [ + {"type": "Collected", "source": "Investigator", "pages": "10"}, + {"type": "Collected", "source": "Investigator", "pages": "20"}, + ] + } + items_instance._add_origin(item, obj) + # Each origin gets the acrf DocumentRef (Collected/Investigator rule) plus its own pages DocumentRef. + page_refs_per_origin = [ + sorted(pr.PageRefs for dr in o.DocumentRef for pr in dr.PDFPageRef) + for o in item.Origin + ] + assert "10" in page_refs_per_origin[0] + assert "20" in page_refs_per_origin[1] + assert "10" not in page_refs_per_origin[1] + + +class TestPostProcessingMultiOrigin: + """post_processing._add_derived_methods must trigger when ANY origin is Derived.""" + + def _build_objects(self, origin_value): + from odmlib.define_2_1 import model as DEFINE + item = _new_itemdef() + item.__dict__["OID"] = "IT.DM.USUBJID" + + items_inst_module = __import__("items") + inst = items_inst_module.Items() + inst.lang = "en" + inst.acrf = "LF.ACRF" + inst._add_origin(item, {"origin": origin_value}) + + igd = object.__new__(DEFINE.ItemGroupDef) + ir = object.__new__(DEFINE.ItemRef) + ir.__dict__["ItemOID"] = item.OID + ir.__dict__["MethodOID"] = None + igd.__dict__["ItemRef"] = [ir] + + return { + "ItemDef": [item], + "ItemGroupDef": [igd], + "ValueListDef": [], + "MethodDef": [], + }, ir + + def test_derived_in_first_origin_triggers_method(self): + import post_processing + objects, ir = self._build_objects([{"type": "Derived"}, {"type": "Predecessor"}]) + post_processing.PostProcessing(objects, is_xpt=False, lang="en").process_define_objects() + assert ir.MethodOID is not None + assert len(objects["MethodDef"]) == 1 + + def test_derived_in_later_origin_still_triggers_method(self): + import post_processing + objects, ir = self._build_objects( + [{"type": "Collected", "source": "Investigator"}, {"type": "Derived"}] + ) + post_processing.PostProcessing(objects, is_xpt=False, lang="en").process_define_objects() + assert ir.MethodOID is not None + assert len(objects["MethodDef"]) == 1 + + def test_no_derived_origin_skips_method(self): + import post_processing + objects, ir = self._build_objects( + [{"type": "Collected", "source": "Investigator"}, {"type": "Predecessor"}] + ) + post_processing.PostProcessing(objects, is_xpt=False, lang="en").process_define_objects() + assert ir.MethodOID is None + assert objects["MethodDef"] == []