CDISC01_1 CDISC Test Study Modified to illustrate Define-XML 2.1 features CDISC01-1 BILI GLUC BLOOD BUN HGB LYM BLOOD HCT BLOOD LOCAL LAB HCT BLOOD LOCAL LAB GLUC OCCBLD URINE PH URINE VITB12 SERUM VITB9 BLOOD RACE1 RACE2 RACE3 RAND RANDNO SAFETY VSCLSIG AGEMAX AGEMIN AGEU DOSE FCNTRY PLANSUB DIABP FRMSIZE HEIGHT PULSE SYSBP WEIGHT BMI HEIGHT CAN MEX HEIGHT USA WEIGHT CAN MEX WEIGHT USA Trial Summary ts.xpt Device Identifiers di.xpt Demographics dm.xpt Exposure as Collected ec.xpt Exposure ex.xpt Laboratory Tests Results lb.xpt Vital Signs vs.xpt S Findings xs.xpt X Findings Supplemental Qualifiers for DM suppdm.xpt Supplemental Qualifiers for VS Age Age Units Description of Planned Arm Planned Arm Code Date/Time of Birth Country Domain Abbreviation Ethnicity Race Subject Reference End Date/Time Subject Reference Start Date/Time Sex Study Site Identifier Subject Identifier for the Study Domain Abbreviation Dose per Administration Dose Form Dose Units End Date/Time of Treatment Study Day of End of Treatment Sequence Number Start Date/Time of Treatment Study Day of Start of Treatment Name of Actual Treatment Domain Abbreviation Dose per Administration Dose Form EC.ECDOSFRM Dose Units End Date/Time of Treatment EC.ECENDTC Study Day of End of Treatment Sequence Number Start Date/Time of Treatment EC.ECSTDTC Study Day of Start of Treatment Name of Actual Treatment Domain Abbreviation Baseline Flag Category for Lab Test Date/Time of Specimen Collection Study Day of Specimen Collection Fasting Status Method of Test or Examination Reference Range Indicator Reference Range Upper Limit in Orig Unit Reference Range Lower Limit in Orig Unit Result or Finding in Original Units Original Units Specimen ID Sequence Number Vendor Name Specimen Type Reference Range for Char Rslt-Std Units Reference Range Upper Limit-Std Units Reference Range Lower Limit-Std Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Lab Test or Examination Name Lab Test or Examination Short Name Visit Name Planned Study Day of Visit Visit Number Related Domain Abbreviation Study Identifier Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Domain Abbreviation Trial Summary Parameter Trial Summary Parameter Short Name Sequence Number Parameter Value Unique Subject Identifier Domain Abbreviation Visit Name Planned Study Day of Visit Visit Number Baseline Flag Date/Time of Measurements Study Day of Vital Signs Result or Finding in Original Units Original Units Vital Signs Position of Subject Sequence Number Character Result/Finding in Std Format EDC System Numeric Result/Finding in Standard Units Standard Units Vital Signs Test Name Vital Signs Test Short Name Domain Abbreviation Visit Name Planned Study Day of Visit Visit Number Baseline Flag Date/Time of Measurements Study Day of Vital Signs Result or Finding in Original Units Original Units Sequence Number Character Result/Finding in Std Format EDC System Numeric Result/Finding in Standard Units Standard Units S Findings Test Name S Findings Test Short Name Domain Abbreviation Visit Name Planned Study Day of Visit Visit Number Baseline Flag Date/Time of Measurements Study Day of Vital Signs Result or Finding in Original Units Original Units Sequence Number Character Result/Finding in Std Format EDC System Numeric Result/Finding in Standard Units Standard Units X Findings Test Name X FindingsTest Short Name Domain Abbreviation Sponsor Device Identifier Sequence Number Device Identifier Element Short Name Device Identifier Element Name Device Identifier Element Value Result or Finding in Orig Units - Set 1 From Central lab (LB.LBNAM NE "LOCAL LAB") Result or Finding in Orig Units - Set 2 From Central lab (LB.LBNAM NE "LOCAL LAB") Result or Finding in Orig Units Set 3 From Central lab (LB.LBNAM NE "LOCAL LAB") Hematocrit From Central lab (LB.LBNAM NE "LOCAL LAB") Hematocrit From Local lab (LB.LBNAM="LOCAL LAB"). Note that the CRF page reference is given only for illustration purposes. The sample acrf.pdf does not include the local lab CRF page. pH From Central lab (LB.LBNAM NE "LOCAL LAB") Vitamin B12 From Central lab (LB.LBNAM NE "LOCAL LAB") Vitamin B9 From Central lab (LB.LBNAM NE "LOCAL LAB") Race 1 Race 2 Race 3 Randomized Population Flag Randomization Number Safety Population Flag Clinically Significant Planned Maximum Age of Subjects Planned Minimum Age of Subjects Age Unit Dose per Administration Planned Country of Investigational Sites Planned Number of Subjects Diastolic Blood Pressure in Orig U Body Frame Size - Orig Height in Orig U Pulse Rate in Orig U Systolic Blood Pressure in Orig U Weight in Orig U Height: Original Units MC Height: Original Units NMC Weight: Original Units MC Weight: Original Units NMC Diastolic Blood Pressure Char in Std U Body Frame Size - Std Height Char in Std U Pulse Rate Char in Std U Systolic Blood Pressure Char in Std U Weight Char in Std U BMI (Std U) Diastolic Blood Pressure Num in Std U Height Num in Std U Pulse Rate Num in Std U Systolic Blood Pressure Num in Std U Weight Num in Std U BMI Num in Std U EDC System Miracle Drug 10 mg Miracle Drug 20 mg Placebo Screen Failure United States of America (the) Canada Mexico Device Identifiers Demographics Exposure as Collected Exposure tab Laboratory Data Percentage X10^9/L Gram per Deciliter Milligram per Deciliter Nanogram per Deciliter pg/mL Bilirubin Blood Urea Nitrogen Glucose Hematocrit Hemoglobin Lymphocytes Occult Blood pH Vitamin B12 Vitamin B9 Yes No Unknown Female Male Unknown Undifferentiated Trial Summary Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Age Span Age Unit Dose per Administration Dosing Frequency Dose Units Planned Country of Investigational Sites Trial Length Trial Primary Objective Trial Secondary Objective Planned Number of Subjects Trial is Randomized Route of Administration Sex of Participants Clinical Study Sponsor Trial Blinding Schema Control Type Trial Indication Type Trial Title Trial Phase Classification Investigational Therapy or Treatment Trial Type Centimeter Inch Kilogram Pound Vital Signs Beats per Minute Centimeter Kilogram Millimeter of Mercury Kilogram per Square Meter Body Mass Index Diastolic Blood Pressure Body Frame Size Height Pulse Rate Systolic Blood Pressure Weight g/dL mg/dL Test 1 Test 2 Test 3 g/dL mg/dL % Test 11 Test 12 Test 13 Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. character value of VSSTRESN %convert_to_character_versionx(numeric_value=bmi_numeric_value,length=bmi_defined_lenght,sd=bmi_defined_sd) putc(bmi_numeric_value,best.) toString(bmi_numeric_value, witdth=NULL) round((VSSTRESN for weight/ (VSSTRESN for height / 100)^2), .01). Note: height and weight at the closest visit collected. %bmisn_versionx(weight=retrieved_weight_closest_visit,height=retrieved_height_closest_visit) %bmisn_versiony(weight=retrieved_weight_closest_visit,height=retrieved_height_closest_visit) Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. ECENDY = ECENDTC-RFSTDTC+1 if ECENDTC is on or after RFSTDTC. ECENDTC - RFSTDTC if ECENDTC precedes RFSTDTC. If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0. Derived from ARM, ARMCD - equal to mg EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC. EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC. Derived from ARM, ARMCD Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise. LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC. Reference Range Indicator based upon standard results and ranges. Selected value converted to upper case to match CT. Domain abbreviation from where data originated. RFENDTC = termination date, for safety subjects. Null for screen failures. RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures. SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise. Sequential number identifying records within each USUBJID in the domain. Sequential number identifying records within each TSPARM in the domain. Concatenation of STUDYID and SUBJID Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise. VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC. Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data. Safety subjects only: XSBLFL = "Y" for last record with non Null XSORRES on or before the first dose date (RFSTDTC). Null otherwise. XSDY = XSDTC-RFSTDTC+1 if XSDTC is on or after RFSTDTC. XSDTC - RFSTDTC if XSDTC precedes RFSTDTC. Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). BMI is calculated by the EDC system (operationally derived) as follows: round((XSSTRESN for weight/ (XSSTRESN for height / 100)^2), .01). Note: If height is not collected at a visit, use the height collected at screening. XSSTRESN = numeric value of XSSTRESC, when XSSTRESC contains numeric data. Safety subjects only: XXBLFL = "Y" for last record with non Null XXORRES on or before the first dose date (RFSTDTC). Null otherwise. XXDY = XXDTC-RFSTDTC+1 if XXDTC is on or after RFSTDTC. XXDTC - RFSTDTC if XXDTC precedes RFSTDTC. Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). BMI is calculated by the EDC system (operationally derived) as follows: round((XXSTRESN for weight/ (XXSTRESN for height / 100)^2), .01). Note: If height is not collected at a visit, use the height collected at screening. XXSTRESN = numeric value of XXSTRESC, when XXSTRESC contains numeric data. Defaulted to YEARS Assigned from TA.ARM based on ARMCD. Assigned based on Randomization Number. See Note 2.1 This is a subset of the ISO-3166 (Country Codes) codelist Assuming the CT was not upversioned for this study The CT version applicable for the new Domain is the 2015-12-18 version The Domain codelist was updated when SDTMIG 3.2 became production. Referencing a newer CT version that includes the revised codelist The term "UN" was changed to "UNDIFERENTIATED" for codelist "SEX" on the 2014-03-28 CT release. Referencing the codelist from a newer release since the new release includes other codelists used in the study. The DI domain is included to illustrate the use of a separate complementary SDTMIG. In this example, the device ID is referenced from a Findings Domain (XS). See Reviewer's Guide, Section 2.1 Demographics Name of the variables for the related records. Value of identifying variable described in IDVAR. The code values used are the Alpha-3 codes Assuming the LBNRIND is derived by the vendor Origin specified at Value Level Metadata Note this example does not include VLM for this variable since it is just an example and the way to specify VLM is illustrated for LBORRESU. Accession number Note that the study protocol has been amended to not allow the specification of other race per current regulatory requirements. Refer to FDA Guidance XYZ and PMDA Guidance P-XYZ. Planned Numeric tests were not performed. The CDISC01 study was modeled on a very old SDTMIG and no attempt was done yet to upversion it to a newer SDTMIG As an example, the CDISC01 study was adjusted to include a new Domain available in SDTM IG 3.2 As an example, the CDISC01 study was adjusted to include a new Domain available in SDTMIG-MD 1.0. The XS Domain is expected to reference the device used with variable SPDEVID. This is the CDISC CT Package 60 (2025-09-29) associated to the CDISC Define-XML Specification Version 2.1.10. The data submitted only includes subjects in the USA since other sites did not enroll any subjects. Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset. Assigned from the TV domain based on the VISIT Testing a comment in addition to a method: BMI is derived and the specific method is provided at VLM Testing a comment in addition to a method: BMI is operationally derived and the specific method is provided at VLM Standard units consistent with CDISC controlled terminology Special domain contingent on rare conditions observed. Annotated CRF Reviewers Guide Complex Algorithms