Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C165635 No ADaM Basic Data Structure Subclass BDSSC ADaM Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM basic data structure. CDISC Define-XML ADaM Basic Data Structure Subclass Terminology C172452 C165635 ADaM Basic Data Structure Subclass NON-COMPARTMENTAL ANALYSIS NCA A dataset containing data that is used for non-compartmental analyses. Non-Compartmental Analysis Dataset C189348 C165635 ADaM Basic Data Structure Subclass POPULATION PHARMACOKINETIC ANALYSIS PPK A dataset containing data that is used for population pharmacokinetic analyses. Population Pharmacokinetic Analysis Dataset C165637 C165635 ADaM Basic Data Structure Subclass TIME-TO-EVENT TTE A dataset containing data that is used for Time-to-Event analyses. Time-to-Event Dataset C177903 No ADaM Medical Device Basic Data Structure Subclass MDBDSSC ADaM Medical Device Basic Data Structure Subclass Terminology relevant to the subclasses of the ADaM device level basic data structure. CDISC Define-XML ADaM Medical Device Basic Data Structure Subclass Terminology C177920 C177903 ADaM Medical Device Basic Data Structure Subclass MEDICAL DEVICE TIME-TO-EVENT MDTTE A dataset containing data that is used for medical device Time-to-Event analyses. Medical Device Time-to-Event Dataset C176227 No ADaM Occurrence Data Structure Subclass OCCSC ADaM Occurrence Data Structure Subclass Terminology relevant to the subclasses of the ADaM occurrence data structure. CDISC Define-XML ADaM Occurrence Data Structure Subclass Terminology C176265 C176227 ADaM Occurrence Data Structure Subclass ADVERSE EVENT AE A dataset containing data that is used for adverse event analyses. Adverse Event Dataset C117745 Yes Analysis Purpose ANLPURP Analysis Purpose Purpose of a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Purpose Terminology C98724 C117745 Analysis Purpose EXPLORATORY OUTCOME MEASURE Exploratory Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure C98772 C117745 Analysis Purpose PRIMARY OUTCOME MEASURE Primary Outcome Measure The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure C98781 C117745 Analysis Purpose SECONDARY OUTCOME MEASURE Secondary Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure C117744 Yes Analysis Reason ANLREAS Analysis Reason Reason for reporting a specific analysis result described in Define-XML analysis results metadata. CDISC Define-XML Analysis Reason Terminology C117750 C117744 Analysis Reason DATA DRIVEN The analysis was triggered by findings in the data. Data Driven Analysis C117751 C117744 Analysis Reason REQUESTED BY REGULATORY AGENCY The analysis has been requested by a regulatory agency. Analysis Requested by Regulatory Agency C117752 C117744 Analysis Reason SPECIFIED IN PROTOCOL The analysis is specified in a protocol. Analysis Specified in Protocol C117753 C117744 Analysis Reason SPECIFIED IN SAP The analysis is specified in a statistical analysis plan. Analysis Specified in Statistical Analysis Plan C172331 No CDISC Controlled Terminology Standard Type CTSTDTYP CDISC Controlled Terminology Standard Type Terminology relevant to the classification of the CDISC controlled terminology standard described in the Define-XML document. CDISC Define-XML CDISC Controlled Terminology Standard Type Terminology C180548 C172331 CDISC Controlled Terminology Standard Type ADaM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model (ADaM). CDISC ADaM Standard Terminology C180549 C172331 CDISC Controlled Terminology Standard Type CDASH The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH) group. CDISC CDASH Standard Terminology C180550 C172331 CDISC Controlled Terminology Standard Type DEFINE-XML The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Define-XML standard. CDISC Define-XML Standard Terminology C180551 C172331 CDISC Controlled Terminology Standard Type SDTM The controlled terminology standard subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). CDISC SDTM Standard Terminology C180552 C172331 CDISC Controlled Terminology Standard Type SEND The controlled terminology standard subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Non-clinical Data (SEND) group. CDISC SEND Standard Terminology C66788 Yes Dictionary Name DICTNAM Dictionary Name Terminology relevant to the names given to a reference source that lists words and gives their meaning. CDISC Dictionary Name Terminology C163415 C66788 Dictionary Name CDISC CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology C49471 C66788 Dictionary Name COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) Thesaurus of Adverse Reaction Term Coding Symbols C49704 C66788 Dictionary Name CTCAE Common Terminology Criteria for Adverse Events A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. (NCI) Common Terminology Criteria for Adverse Events C134003 C66788 Dictionary Name D-U-N-S NUMBER Data Universal Number System; DUNS Numbers A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. Data Universal Numbering System C49474 C66788 Dictionary Name ICD International Classification of Diseases A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) International Classification of Diseases C37978 C66788 Dictionary Name ICD-O International Classification of Diseases for Oncology A World Health Organization (WHO) multi-axial classification of the site, morphology, behaviour, and grading of neoplasms. International Classification of Diseases for Oncology C81895 C66788 Dictionary Name ISO 21090 An international standard for harmonized data types for information interchange, developed and maintained by the International Organization for Standards (ISO). ISO 21090 C209537 C66788 Dictionary Name ISO 3166 An international standard for country and subdivision codes, developed and maintained by the International Organization for Standards (ISO). ISO 3166 C49476 C66788 Dictionary Name LOINC Logical Observation Identifiers Names and Codes Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI) Logical Observation Identifiers Names and Codes C163416 C66788 Dictionary Name MED-RT Medication Reference Terminology; NDF-RT A standard terminology developed and maintained by the Veterans Health Administration (VHA) that includes terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of medications. MED-RT incorporates terminology from RxNORM, MeSH, and SNOMED CT. Medication Reference Terminology C43820 C66788 Dictionary Name MedDRA Medical Dictionary for Regulatory Activities An international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information, particularly to regulatory authorities. MedDRA C53489 C66788 Dictionary Name SNOMED Systematized Nomenclature of Medicine A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. (CDISC Glossary) Systematized Nomenclature of Medicine C163417 C66788 Dictionary Name UNII SRS-UNII; Substance Registration System-Unique Ingredient Identifier A standard terminology developed and maintained by the Department of Veterans Affairs/Veterans Health Administration designated federal collaborative Structured Product Labeling Interagency Expert Panel (SPLIEP). It contains terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of drug ingredients and food allergens. Substance Registration System-Unique Ingredient Identifier C154331 C66788 Dictionary Name WHO ATC CLASSIFICATION SYSTEM Anatomical Therapeutic Chemical Classification System A World Health Organization (WHO) classification system, developed and maintained by the WHO Collaborating Centre for Drug Statistics Methodology, for medicinal substances where active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties. Anatomical Therapeutic Chemical Classification System C49468 C66788 Dictionary Name WHOART World Health Organization Adverse Reaction Terms A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) World Health Organization Adverse Reaction Terminology C49475 C66788 Dictionary Name WHODD WHODrug Global; World Health Organization Drug Dictionary A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI) World Health Organization Drug Dictionary C103329 No General Observation Class GNRLOBSC General Observation Class Terminology related to the classification of a CDISC domain. CDISC Define-XML General Observation Class Terminology C103375 C103329 General Observation Class ADAM OTHER ADaM Other An analysis dataset that doesn't conform to a pre-defined ADaM dataset structure (e.g. ADSL, BDS or OCCDS). CDISC Other ADaM Dataset C103371 C103329 General Observation Class BASIC DATA STRUCTURE Basic Data Structure; BDS An ADaM BDS dataset contains one or more records per subject, per analysis parameter, per analysis time point. Variables include the value being analyzed (e.g., AVAL) and the description of the value being analyzed (e.g., PARAM). Other variables in the dataset provide more information about the value being analyzed (e.g., the subject identification) or describe and trace the derivation of it (e.g., DTYPE) or support the analysis of it (e.g., treatment variables, covariates). CDISC Basic Data Structure Dataset C177921 C103329 General Observation Class DEVICE LEVEL ANALYSIS DATASET ADDL; Device Level Analysis Dataset The Device-Level Analysis Dataset (ADDL) is a one-record-per-device or one-record-per-subject-per-device dataset which contains variables that describe device characteristics and timing, and group the devices for analysis. ADDL is the primary source for device-level variables included in other analysis datasets. CDISC Device Level Analysis Dataset C103372 C103329 General Observation Class EVENTS Events This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). CDISC Events Class C135396 C103329 General Observation Class FINDINGS ABOUT Findings About This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. CDISC Findings About Class C103373 C103329 General Observation Class FINDINGS Findings This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. CDISC Findings Class C103374 C103329 General Observation Class INTERVENTIONS Interventions This SDTM class captures investigational, therapeutic and other products that are administered to the subject either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). CDISC Interventions Class C177922 C103329 General Observation Class MEDICAL DEVICE BASIC DATA STRUCTURE MDBDS; Medical Device Basic Data Structure The Medical Device Basic Data Structure (MDBDS) supports the analysis needs by adding SPDEVID as a required key variable and USUBJID a conditionally required variable. See the BDS class for further details. CDISC Medical Device Basic Data Structure C177923 C103329 General Observation Class MEDICAL DEVICE OCCURRENCE DATA STRUCTURE MDOCCDS; Medical Device Occurrence Data Structure The Medical Device Occurrence Data Structure (MDOCCDS) supports the analysis needs by adding SPDEVID as a required identifier and allowing USUBJID be a conditionally required variable. See the OCCDS class for further details. CDISC Medical Device Occurrence Data Structure C123454 C103329 General Observation Class OCCURRENCE DATA STRUCTURE OCCDS; Occurrence Data Structure The Occurrence Data Structure (OCCDS) is the ADaM data structure for occurrence analysis. Occurrence analysis is the counting of subjects with a record or term, and often includes a structured hierarchy of dictionary coding categories. CDISC Occurrence Data Structure C204611 C103329 General Observation Class REFERENCE DATA STRUCTURE RDS; REFERENDS The Reference Data Structure (RDS) is the ADaM data structure for reference data. Reference data captures historic trends and results that are used as input for study analyses. Reference Data Structure C103376 C103329 General Observation Class RELATIONSHIP Relationships This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. CDISC Relationship Class C103377 C103329 General Observation Class SPECIAL PURPOSE Special Purpose; SPECIAL-PURPOSE This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE, SJ, SM and SV. CDISC Special Purpose Class C147271 C103329 General Observation Class STUDY REFERENCE Study Reference This special purpose SDTM class contains further descriptions of study-specific identifiers that will be used in subject based domains. CDISC Study Reference Class C103378 C103329 General Observation Class SUBJECT LEVEL ANALYSIS DATASET ADSL; Subject Level Analysis Dataset The Subject-Level Analysis Dataset (ADSL) is a one-record-per-subject dataset which contains variables that describe subject demographic characteristics and group the subjects for analysis. ADSL is the primary source for subject-level variables included in other analysis datasets such as population flags and treatment variables. CDISC Subject Level Analysis Dataset C103379 C103329 General Observation Class TRIAL DESIGN Trial Design This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control group, method of allocating treatments, blinding methods, assignment of epochs that subjects pass through in the course of a trial. CDISC Trial Design Class C170448 No ODM Context ODMCNTX ODM Context Terminology relevant to the context in which the Define-XML document is used. CDISC Define-XML ODM Context Terminology C17649 C170448 ODM Context Other Other Different than the one(s) previously specified or mentioned. (NCI) Other C70885 C170448 ODM Context Submission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. Regulatory Submission C170450 No Origin Source ORIGINS Origin Source Terminology relevant to the origin source for datasets in the Define-XML document. CDISC Define-XML Origin Source Terminology C25936 C170450 Origin Source Investigator A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) Investigator C70793 C170450 Origin Source Sponsor Clinical Study Sponsor; Sponsor; Study Sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] Clinical Study Sponsor C41189 C170450 Origin Source Subject An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. Study Subject C68608 C170450 Origin Source Vendor A person or agency that promotes or exchanges goods or services for money. (NCI) Vendor C170449 No Origin Type ORIGINT Origin Type Terminology relevant to the origin type for datasets in the Define-XML document. CDISC Define-XML Origin Type Terminology C170547 C170449 Origin Type Assigned A value that is derived through designation, such as values from a look up table or a label on a CRF. Assigned Value C170548 C170449 Origin Type Collected A value that is actually observed and recorded by a person or obtained by an instrument. Collected Value C170549 C170449 Origin Type Derived A value that is calculated by an algorithm or reproducible rule, and which is dependent upon other data values. Derived Value C126101 C170449 Origin Type Not Available A value that is not discoverable or accessible. Not Available C17649 C170449 Origin Type Other Other Different than the one(s) previously specified or mentioned. (NCI) Other C170550 C170449 Origin Type Predecessor A value that is copied from another variable. Copied Value C170551 C170449 Origin Type Protocol A value that is included as part of the study protocol. Protocol Value C160924 Yes SDTMIG Version Response SDTMIGRS SDTMIG Version Response A terminology codelist relevant to the version of the CDISC Study Data Tabulation Model implementation guide that is being used in the study submission. CDISC SDTM Implementation Guide Version Response Terminology C161432 C160924 SDTMIG Version Response 3.1.1 SDTMIG Version 3.1.1 Version 3.1.1 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.1.1 C161433 C160924 SDTMIG Version Response 3.1.2 SDTMIG Version 3.1.2 Version 3.1.2 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.1.2 C161435 C160924 SDTMIG Version Response 3.1.3 SDTMIG Version 3.1.3 Version 3.1.3 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.1.3 C161436 C160924 SDTMIG Version Response 3.2 SDTMIG Version 3.2 Version 3.2 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.2 C161437 C160924 SDTMIG Version Response 3.3 SDTMIG Version 3.3 Version 3.3 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.3 C189638 C160924 SDTMIG Version Response 3.4 SDTMIG Version 3.4 Version 3.4 of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.4 C161434 C160924 SDTMIG Version Response Version 3.1.2 Amendment 1 SDTMIG Version 3.1.2 Amendment 1 Amendment 1 of the 3.1.2 version of the CDISC Study Data Tabulation Model (SDTM) Implementation Guide. CDISC SDTM Implementation Guide Version 3.1.2 Amendment 1 C170452 No Standard Name STDNAM Standard Name Terminology relevant to the name of the standard described in the Define-XML document. CDISC Define-XML Standard Name Terminology C214535 C170452 Standard Name ADaM-OCCDSIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard (ADaM) structure for occurrence data standard. ADaM Implementation Guide For Occurrence Data Structure C170552 C170452 Standard Name ADaMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard. ADaM Implementation Guide C214532 C170452 Standard Name ADaMIG-MD The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard (ADaM) Medical Devices standard. ADaM Implementation Guide For Medical Devices C214533 C170452 Standard Name ADaMIG-NCA The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard (ADaM) non-compartmental analysis input data standard. ADaM Implementation Guide For Non-Compartmental Analysis Input Data C214534 C170452 Standard Name ADaMIG-popPK The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard (ADaM) Basic Data Structure for population pharmacokinetic analysis standard. ADaM Implementation Guide For Population Pharmacokinetic Analysis C191213 C170452 Standard Name BIMO Bioresearch Monitoring Technical Conformance Guide The US Food and Drug Administration's (US FDA) dataset specification Bioresearch Monitoring Technical Conformance Guide. Bioresearch Monitoring Technical Conformance Guide C163415 C170452 Standard Name CDISC/NCI CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology C170455 C170452 Standard Name SDTMIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model standard. SDTM Implementation Guide C170553 C170452 Standard Name SDTMIG-AP The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Associated Persons standard. SDTM Implementation Guide-Associated Persons C170554 C170452 Standard Name SDTMIG-MD The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Medical Devices standard. SDTM Implementation Guide-Medical Devices C170456 C170452 Standard Name SENDIG The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data standard. SEND Implementation Guide C181230 C170452 Standard Name SENDIG-AR The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Animal Rule standard. SEND Implementation Guide-Animal Rule C170556 C170452 Standard Name SENDIG-DART The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Developmental and Reproductive Toxicology standard. SEND Implementation Guide-Developmental and Reproductive Toxicology C199687 C170452 Standard Name SENDIG-GENETOX The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) Genetic Toxicology standard. SEND Implementation Guide-Genetic Toxicology C172332 Yes Standard Status STDSTAT Standard Status Terminology relevant to the development or publication status of the standard. CDISC Define-XML Standard Status Terminology C172453 C172332 Standard Status DRAFT A preliminary version of a CDISC standard that has not yet completed the CDISC standards development process. (NCI) CDISC Draft Standard C172455 C172332 Standard Status FINAL A final version of a CDISC standard that has completed the CDISC standards development process. (NCI) CDISC Final Standard C172454 C172332 Standard Status PROVISIONAL A version of a CDISC standard whose conclusiveness is dependent upon the fulfillment of some contingency or final alteration. (NCI) CDISC Provisional Standard C170451 No Standard Type STDTYP Standard Type Terminology relevant to the classification of the standard described in the Define-XML document. CDISC Define-XML Standard Type Terminology C163415 C170451 Standard Type CT CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. Clinical Data Interchange Standards Consortium Controlled Terminology C170454 C170451 Standard Type IG CDISC Implementation Guide A standard document developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) that contains instructions and requirements for the organization, structure, and format of standard clinical and non-clinical trial tabulation and analysis datasets. CDISC Implementation Guide