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1 SDTMIG 3.3 SUPPQUAL 1 STUDYID Study Identifier Char   Identifier Study identifier of the parent record(s). Req Relationships STUDYID
2 SDTMIG 3.3 SUPPQUAL 2 RDOMAIN Related Domain Abbreviation Char (DOMAIN) Identifier Two-character abbreviation for the domain of the parent record(s). Req Relationships RDOMAIN
3 SDTMIG 3.3 SUPPQUAL 3 USUBJID Unique Subject Identifier Char   Identifier Unique subject identifier of the parent record(s). Req Relationships USUBJID
4 SDTMIG 3.3 SUPPQUAL 4 IDVAR Identifying Variable Char   Identifier Identifying variable in the dataset that identifies the related record(s). Examples: --SEQ, --GRPID. Exp Relationships IDVAR
5 SDTMIG 3.3 SUPPQUAL 5 IDVARVAL Identifying Variable Value Char   Identifier Value of identifying variable of the parent record(s). Exp Relationships IDVARVAL
6 SDTMIG 3.3 SUPPQUAL 6 QNAM Qualifier Variable Name Char   Topic The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. Req Relationships QNAM
7 SDTMIG 3.3 SUPPQUAL 7 QLABEL Qualifier Variable Label Char   Synonym Qualifier This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the sponsor's original dataset. Req Relationships QLABEL
8 SDTMIG 3.3 SUPPQUAL 8 QVAL Data Value Char   Result Qualifier Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL. Req Relationships QVAL
9 SDTMIG 3.3 SUPPQUAL 9 QORIG Origin Char   Record Qualifier Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. Examples include "CRF", "Assigned", or "Derived". See Section 4.1.8, Origin Metadata. Req Relationships QORIG
10 SDTMIG 3.3 SUPPQUAL 10 QEVAL Evaluator Char   Record Qualifier Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include "ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR", etc. Exp Relationships QEVAL

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1 2020-03-27 DOMAIN AD     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A two-letter prefix used to denote ADaM-compliant analysis datasets used for statistical analysis and reporting by the sponsor. These are submitted in addition to the data tabulation datasets. Analysis Dataset C49563 Analysis Dataset Domain
2 2020-03-27 DOMAIN AE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains data describing untoward medical occurrences in a patient or subjects that are administered a pharmaceutical product and which may not necessarily have a causal relationship with the treatment. Adverse Events C49562 Adverse Event Domain
3 2020-03-27 DOMAIN AG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains the agents administered to the subject as part of a procedure or assessment, as opposed to drugs, medications and therapies administered with therapeutic intent. Procedure Agents C117755 Procedure Agents Domain
4 2020-03-27 DOMAIN APAE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The adverse events domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Adverse Events C147168 Associated Persons Adverse Events Domain
5 2020-03-27 DOMAIN APBS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The biospecimen domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Biospecimen C147169 Associated Persons Biospecimen Domain
6 2020-03-27 DOMAIN APDD     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The death details domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Death Details C147170 Associated Persons Death Details Domain
7 2020-03-27 DOMAIN APDM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The demographics domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Demographics C132354 Associated Persons Demographics Submission Domain
8 2020-03-27 DOMAIN APEX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The exposure domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Exposure C147171 Associated Persons Exposure Domain
9 2020-03-27 DOMAIN APLB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The laboratory test results domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Laboratory Test Results C147172 Associated Persons Laboratory Test Results Domain
10 2020-03-27 DOMAIN APMH     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The medical history domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Medical History C147173 Associated Persons Medical History Domain
11 2020-03-27 DOMAIN APQS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The questionnaires domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Questionnaires C147174 Associated Persons Questionnaires Domain
12 2020-03-27 DOMAIN APRELSUB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent relationships between associated persons (individuals who are not study subjects, but about whom data is collected) and study subjects. Relationship between Associated Persons and Subjects C147175 Relationship between Associated Persons and Subjects Domain
13 2020-03-27 DOMAIN APRP     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The reproductive system findings domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Reproductive System Findings C147176 Associated Persons Reproductive System Findings Domain
14 2020-03-27 DOMAIN APSC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The subject characteristics domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Subject Characteristics C147177 Associated Persons Subject Characteristics Domain
15 2020-03-27 DOMAIN APSS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The subject status domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Subject Status C147178 Associated Persons Subject Status Domain
16 2020-03-27 DOMAIN APSU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology The substance use domain for those persons associated with the study itself, a particular study subject, or a device used in the study. Associated Persons Substance Use C147179 Associated Persons Substance Use Domain
17 2020-03-27 DOMAIN AX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A two-letter prefix used to denote an analysis dataset that is not compliant with a defined ADaM structure. Non-Compliant ADaM Dataset C111282 Non-Compliant ADaM Datasets Domain
18 2020-03-27 DOMAIN BE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that documents biospecimen collection and storage information. Biospecimen Events C111138 Biospecimen Events Domain
19 2020-03-27 DOMAIN BS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that documents biospecimen handling information. Biospecimen Findings C111137 Biospecimen Domain
20 2020-03-27 DOMAIN CE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains clinical events of interest that would not be classified as adverse events. Clinical Events C85441 Clinical Events Domain
21 2020-03-27 DOMAIN CM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains concomitant and prior medications used by the subject, such as those given on an as needed basis or condition-appropriate medications. Concomitant/Prior Medications C49568 Concomitant Medication Domain
22 2020-03-27 DOMAIN CO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that contains comments that may be collected alongside other data. Comments C49569 Comment Domain
23 2020-03-27 DOMAIN CV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. Cardiovascular System Findings C102605 Cardiovascular System Findings Domain
24 2020-03-27 DOMAIN DA     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains the accountability of study drug, such as information on the receipt, dispensing, return, and packaging. Drug Accountability C49578 Drug Accountability Domain
25 2020-03-27 DOMAIN DD     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains the diagnosis of the cause of death for a subject. Death Details; Death Diagnosis and Details C95087 Death Diagnosis Domain
26 2020-03-27 DOMAIN DE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains data for device-related events. Device Events C102616 Device Events Domain
27 2020-03-27 DOMAIN DI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain containing information that identifies a specific device unit. Device Identifiers C102618 Device Identifiers Domain
28 2020-03-27 DOMAIN DM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that includes a set of essential standard variables that describe each subject in a clinical study. It is the parent domain for all other observations for human clinical subjects. Demographics C49572 Demographics Domain
29 2020-03-27 DOMAIN DO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains the device characteristics that do not vary over the course of the study. Device Properties C102619 Device Properties Domain
30 2020-03-27 DOMAIN DR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that contains the linkage of each subject to the device(s) to which they may have been exposed during the study. Device-Subject Relationships C102620 Device to Subject Relationship Domain
31 2020-03-27 DOMAIN DS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains information encompassing and representing data related to subject disposition. Disposition C49576 Disposition Domain
32 2020-03-27 DOMAIN DT     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A events domain that contains the logistics and disposition information specific to a given device. Device Tracking and Disposition C102621 Device Tracking and Disposition Domain
33 2020-03-27 DOMAIN DU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains the measurements and settings that are intentionally set on a device when it is in use. These are characteristics that exist for the device, and have a specific setting for a use instance. Device In-Use C102622 Device-In-Use Domain
34 2020-03-27 DOMAIN DV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains protocol violations and deviations during the course of the study. Protocol Deviations C49585 Protocol Deviations Domain
35 2020-03-27 DOMAIN DX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains a subject's exposure to a medical device under study. Device Exposure C102617 Device Exposure Domain
36 2020-03-27 DOMAIN EC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains information about protocol-specified study treatment administrations, as collected. Exposure as Collected C117466 Exposure as Collected Domain
37 2020-03-27 DOMAIN ED     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the endocrine system, including the glands and cells that make hormones that are released directly into the blood and travel to tissues and organs all over the body. Endocrine System Findings C102630 Endocrine System Findings Domain
38 2020-03-27 DOMAIN EG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived. ECG Test Results C49626 Electrocardiogram Domain
39 2020-03-27 DOMAIN EX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. Exposure C49587 Exposure Domain
40 2020-03-27 DOMAIN FA     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains the findings about an event or intervention that cannot be represented within an events or interventions domain record or as a supplemental qualifier. Findings About Events or Interventions C85442 Findings About Events or Interventions Domain
41 2020-03-27 DOMAIN FT     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains data for named, stand-alone, task-based evaluations designed to provide an assessment of mobility, dexterity, or cognitive ability. Functional Tests C117756 Functional Tests Domain
42 2020-03-27 DOMAIN GI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the gastrointestinal system, including the esophagus, stomach, small and large intestine, anus, liver, biliary tract and pancreas. Gastrointestinal System Findings C102640 Digestive System Findings Domain
43 2020-03-27 DOMAIN HM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the hematopoietic system, including the bone marrow and lymph nodes involved in the production of blood. Hematopoietic System Findings C102641 Hematopoietic System Findings Domain
44 2020-03-27 DOMAIN HO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A events domain that contains data for inpatient and outpatient healthcare events (e.g., hospitalization, nursing home stay, rehabilitation facility stay, ambulatory surgery). Healthcare Encounters C117757 Healthcare Encounters Domain
45 2020-03-27 DOMAIN IE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. Inclusion/Exclusion Criteria Not Met C61536 Inclusion Exclusion Criteria Not Met Domain
46 2020-03-27 DOMAIN IG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the integumentary system, including the epidermis, dermis, and all of their derivatives including hairs, nails, sudoriferous glands, and sebaceous glands. Integumentary System Findings C102651 Integumentary System Findings Domain
47 2020-03-27 DOMAIN IS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain for assessments that determine whether a therapy induced an immune response. Immunogenicity Specimen Assessments C112320 Immunogenicity Specimen Assessments Domain
48 2020-03-27 DOMAIN LB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. Laboratory Test Results C49592 Laboratory Data Domain
49 2020-03-27 DOMAIN MB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that represents non-host organisms identified including bacteria, viruses, parasites, protozoa and fungi. Microbiology Specimen C49602 Microbiology Specimen Domain
50 2020-03-27 DOMAIN MH     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An events domain that contains data that includes the subject's prior medical history at the start of the trial. Medical History C49603 Medical History Domain
51 2020-03-27 DOMAIN MI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains histopathology findings and microscopic evaluations. Microscopic Findings C95095 Microscopic Findings Domain
52 2020-03-27 DOMAIN MK     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the system of muscles, tendons, ligaments, bones, joints, and associated tissues. Musculoskeletal System Findings C102674 Musculoskeletal Findings, Connective and Soft Tissue Findings Domain
53 2020-03-27 DOMAIN ML     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains information describing a subject's food product consumption. Meal Data C49604 Meal Data Domain
54 2020-03-27 DOMAIN MO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain relevant to the science of the form and structure of an organism or of its parts. Morphology C102671 Morphology Findings Domain
55 2020-03-27 DOMAIN MS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that represents drug susceptibility testing results only. This includes phenotypic testing (where drug is added directly to a culture of organisms) and genotypic tests that provide results in terms of susceptible or resistant. Drug susceptibility testing may occur on a wide variety of non-host organisms, including bacteria, viruses, fungi, protozoa and parasites. Microbiology Susceptibility C61531 Microbiology Susceptibility Domain
56 2020-03-27 DOMAIN NV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the nervous system, including the brain, spinal cord, the cranial and spinal nerves, autonomic ganglia and plexuses. Nervous System Findings C102677 Nervous System Findings Domain
57 2020-03-27 DOMAIN OE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains tests that measure a person's ocular health and visual status, to detect abnormalities in the components of the visual system, and to determine how well the person can see. Ophthalmic Examinations C147180 Ophthalmic Examinations Domain
58 2020-03-27 DOMAIN OI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain containing information that identifies levels of taxonomic nomenclature of microbes or parasites that have been either experimentally determined in the course of a study or are previously known, as in the case of lab strains used as reference in the study. Non-host Organism Identifiers C161329 Non-host Organism Identifiers Domain
59 2020-03-27 DOMAIN PB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that relates a set of genetic variations to an inference about the medical meaning of that set of genetic variations. Pharmacogenomics Biomarker C106552 Pharmacogenomics Biomarker Domain
60 2020-03-27 DOMAIN PC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time. Pharmacokinetics Concentrations C49606 Pharmacokinetic Concentration Domain
61 2020-03-27 DOMAIN PE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains findings observed during a physical examination where the body is evaluated by inspection, palpation, percussion, and auscultation. Physical Examination C49608 Physical Exam Domain
62 2020-03-27 DOMAIN PF     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain for gene expression and genetic variation assessments. Pharmacogenomics/Genetics Findings C111289 Pharmacogenomics Findings Domain
63 2020-03-27 DOMAIN PG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains supporting information for pharmacogenomics/genetics findings that applies to the entire test and not an individual findings result. Pharmacogenomics/Genetics Methods and Supporting Information C61529 Pharmacogenomics Domain
64 2020-03-27 DOMAIN POOLDEF     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset that identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured. Pool Definition C147181 Pool Definition Dataset
65 2020-03-27 DOMAIN PP     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. Pharmacokinetic Parameters C49607 Pharmacokinetic Parameters Domain
66 2020-03-27 DOMAIN PR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. Procedures C102700 Procedure Domain
67 2020-03-27 DOMAIN QS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains data for named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis. Questionnaires C49609 Questionnaire Domain
68 2020-03-27 DOMAIN RE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi and lungs. Respiratory System Findings C95098 Respiratory Domain
69 2020-03-27 DOMAIN RELREC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. Related Records C147182 Related Records Dataset
70 2020-03-27 DOMAIN RELSUB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent relationships between study subjects. Related Subjects C147183 Related Subjects Dataset
71 2020-03-27 DOMAIN RP     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the male and female reproductive systems. Reproductive System Findings C102707 Reproductive System Findings Domain
72 2020-03-27 DOMAIN RS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain for the assessment of disease response to therapy, or clinical classification based on published criteria. Disease Response and Clin Classification C107097 Disease Response Domain
73 2020-03-27 DOMAIN SB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special purpose domain that associates the subject with the medical conclusions contained in the pharmacogenomics biological state (PB) domain based on the observations reported in pharmacogenomics findings (PF) domain. Subject Biomarker C106571 Subject Biomarker Domain
74 2020-03-27 DOMAIN SC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains subject-related data not collected in other domains. Subject Characteristics C49610 Subject Characteristics Domain
75 2020-03-27 DOMAIN SE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. Subject Elements C49616 Subject Element Domain
76 2020-03-27 DOMAIN SM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that is designed to record the timing, for each subject, of disease milestones that have been defined in the Trial Disease Milestones (TM) domain. Subject Disease Milestones C147184 Subject Disease Milestones Domain
77 2020-03-27 DOMAIN SR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings about domain for submitting dermal responses to antigens. Skin Response C112420 Skin Response Domain
78 2020-03-27 DOMAIN SS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains general subject characteristics that are evaluated periodically to determine if they have changed. Subject Status C117655 Subject Status Domain
79 2020-03-27 DOMAIN SU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology An interventions domain that contains substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use. Substance Use C49615 Substance Use Domain
80 2020-03-27 DOMAIN SUPPAE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Adverse Events domain. Supplemental Qualifiers for Adverse Events C147185 Adverse Events Supplemental Qualifiers Dataset
81 2020-03-27 DOMAIN SUPPAG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Procedure Agents domain. Supplemental Qualifiers for Procedure Agents C147186 Procedure Agents Supplemental Qualifiers Dataset
82 2020-03-27 DOMAIN SUPPBE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Biospecimen Events domain. Supplemental Qualifiers for Biospecimen Events C147187 Biospecimen Events Supplemental Qualifiers Dataset
83 2020-03-27 DOMAIN SUPPBS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Biospecimen Findings domain. Supplemental Qualifiers for Biospecimen Findings C147189 Biospecimen Findings Supplemental Qualifiers Dataset
84 2020-03-27 DOMAIN SUPPCE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Clinical Events domain. Supplemental Qualifiers for Clinical Events C147191 Clinical Events Supplemental Qualifiers Dataset
85 2020-03-27 DOMAIN SUPPCM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Concomitant/Prior Medications domain. Supplemental Qualifiers for Concomitant/Prior Medications C147193 Concomitant and Prior Medications Supplemental Qualifiers Dataset
86 2020-03-27 DOMAIN SUPPCV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Cardiovascular System Findings (human clinical trials) domain. Supplemental Qualifiers for Cardiovascular System Findings C147195 Cardiovascular System Findings Supplemental Qualifiers Dataset
87 2020-03-27 DOMAIN SUPPDA     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Drug Accountability domain. Supplemental Qualifiers for Drug Accountability C147196 Drug Accountability Supplemental Qualifiers Dataset
88 2020-03-27 DOMAIN SUPPDD     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Death Details (human clinical trials) domain. Supplemental Qualifiers for Death Details (human clinical trials) C147197 Death Details (human clinical trials) Supplemental Qualifiers Dataset
89 2020-03-27 DOMAIN SUPPDE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Device Events domain. Supplemental Qualifiers for Device Events C147198 Device Events Supplemental Qualifiers Dataset
90 2020-03-27 DOMAIN SUPPDM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Demographics domain. Supplemental Qualifiers for Demographics C147200 Demographics Supplemental Qualifiers Dataset
91 2020-03-27 DOMAIN SUPPDO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Device Properties domain. Supplemental Qualifiers for Device Properties C147201 Device Properties Supplemental Qualifiers Dataset
92 2020-03-27 DOMAIN SUPPDS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Disposition domain. Supplemental Qualifiers for Disposition C147203 Disposition Supplemental Qualifiers Dataset
93 2020-03-27 DOMAIN SUPPDT     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Device Tracking and Disposition domain. Supplemental Qualifiers for Device Tracking and Disposition C147204 Device Tracking and Disposition Supplemental Qualifiers Dataset
94 2020-03-27 DOMAIN SUPPDU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Device In-Use domain. Supplemental Qualifiers for Device In-Use C147205 Device In-Use Supplemental Qualifiers Dataset
95 2020-03-27 DOMAIN SUPPDV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Protocol Deviations domain. Supplemental Qualifiers for Protocol Deviations C147206 Protocol Deviations Supplemental Qualifiers Dataset
96 2020-03-27 DOMAIN SUPPDX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Device Exposure domain. Supplemental Qualifiers for Device Exposure C147207 Device Exposure Supplemental Qualifiers Dataset
97 2020-03-27 DOMAIN SUPPEC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Exposure as Collected domain. Supplemental Qualifiers for Exposure as Collected C147208 Exposure as Collected Supplemental Qualifiers Dataset
98 2020-03-27 DOMAIN SUPPEG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the ECG Test Results domain. Supplemental Qualifiers for ECG Test Results C147209 ECG Test Results Supplemental Qualifiers Dataset
99 2020-03-27 DOMAIN SUPPER     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Environmental and Social Factors domain. Supplemental Qualifiers for Environmental and Social Factors C147210 Environmental and Social Factors Supplemental Qualifiers Dataset
100 2020-03-27 DOMAIN SUPPEX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Exposure domain. Supplemental Qualifiers for Exposure C147211 Exposure Supplemental Qualifiers Dataset
101 2020-03-27 DOMAIN SUPPFA     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Findings About Events or Interventions domain. Supplemental Qualifiers for Findings About Events or Interventions C147212 Findings About Events or Interventions Supplemental Qualifiers Dataset
102 2020-03-27 DOMAIN SUPPHO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Healthcare Encounters domain. Supplemental Qualifiers for Healthcare Encounters C147216 Healthcare Encounters Supplemental Qualifiers Dataset
103 2020-03-27 DOMAIN SUPPIE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Inclusion/Exclusion Criteria Not Met domain. Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met C147218 Inclusion/Exclusion Criteria Not Met Supplemental Qualifiers Dataset
104 2020-03-27 DOMAIN SUPPIS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Immunogenicity Specimen Assessments domain. Supplemental Qualifiers for Immunogenicity Specimen Assessments C147219 Immunogenicity Specimen Assessments Supplemental Qualifiers Dataset
105 2020-03-27 DOMAIN SUPPLB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Laboratory Test Results domain. Supplemental Qualifiers for Laboratory Test Results C147220 Laboratory Test Results Supplemental Qualifiers Dataset
106 2020-03-27 DOMAIN SUPPMB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Microbiology domain. Supplemental Qualifiers for Microbiology Specimen C147222 Microbiology Specimen Supplemental Qualifiers Dataset
107 2020-03-27 DOMAIN SUPPMH     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Medical History domain. Supplemental Qualifiers for Medical History C147223 Medical History Supplemental Qualifiers Dataset
108 2020-03-27 DOMAIN SUPPMI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Microscopic Findings domain. Supplemental Qualifiers for Microscopic Findings C147224 Microscopic Findings Supplemental Qualifiers Dataset
109 2020-03-27 DOMAIN SUPPMK     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Musculoskeletal System Findings domain. Supplemental Qualifiers for Musculoskeletal System Findings C147225 Musculoskeletal System Findings Supplemental Qualifiers Dataset
110 2020-03-27 DOMAIN SUPPML     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Meal Data domain. Supplemental Qualifiers for Meal Data C147226 Meal Data Supplemental Qualifiers Dataset
111 2020-03-27 DOMAIN SUPPMO     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Morphology domain. Supplemental Qualifiers for Morphology C165871 Supplemental Qualifiers for Morphology
112 2020-03-27 DOMAIN SUPPMS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Microbiology Susceptibility domain. Supplemental Qualifiers for Microbiology Susceptibility C147227 Microbiology Susceptibility Supplemental Qualifiers Dataset
113 2020-03-27 DOMAIN SUPPNV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Nervous System Findings domain. Supplemental Qualifiers for Nervous System Findings C147228 Nervous System Findings Supplemental Qualifiers Dataset
114 2020-03-27 DOMAIN SUPPOE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Ophthalmic Examinations domain. Supplemental Qualifiers for Ophthalmic Examinations C147229 Ophthalmic Examinations Supplemental Qualifiers Dataset
115 2020-03-27 DOMAIN SUPPPB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Pharmacogenomics/Genetics Biomarker domain. Supplemental Qualifiers for Pharmacogenomics/Genetics Biomarker C147232 Pharmacogenomics/Genetics Biomarker Supplemental Qualifiers Dataset
116 2020-03-27 DOMAIN SUPPPC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Pharmacokinetics Concentrations domain. Supplemental Qualifiers for Pharmacokinetics Concentrations C147233 Pharmacokinetics Concentrations Supplemental Qualifiers Dataset
117 2020-03-27 DOMAIN SUPPPE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Physical Examination domain. Supplemental Qualifiers for Physical Examination C147234 Physical Examination Supplemental Qualifiers Dataset
118 2020-03-27 DOMAIN SUPPPF     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Pharmacogenomics/Genetics Findings domain. Supplemental Qualifiers for Pharmacogenomics/Genetics Findings C147235 Pharmacogenomics/Genetics Findings Supplemental Qualifiers Dataset
119 2020-03-27 DOMAIN SUPPPG     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Pharmacogenomics/Genetics Methods and Supporting Information domain. Supplemental Qualifiers for Pharmacogenomics/Genetics Methods and Supporting Information C147236 Pharmacogenomics/Genetics Methods and Supporting Information Supplemental Qualifiers Dataset
120 2020-03-27 DOMAIN SUPPPP     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Pharmacokinetic Parameters domain. Supplemental Qualifiers for Pharmacokinetic Parameters C147238 Pharmacokinetic Parameters Supplemental Qualifiers Dataset
121 2020-03-27 DOMAIN SUPPPR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Procedures domain. Supplemental Qualifiers for Procedures C147239 Procedures Supplemental Qualifiers Dataset
122 2020-03-27 DOMAIN SUPPQS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Questionnaires domain. Supplemental Qualifiers for Questionnaires C147240 Questionnaires Supplemental Qualifiers Dataset
123 2020-03-27 DOMAIN SUPPQT     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the ECG QT Correction Model Data domain. Supplemental Qualifiers for ECG QT Correction Model Data C147241 ECG QT Correction Model Data Supplemental Qualifiers Dataset
124 2020-03-27 DOMAIN SUPPRE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Respiratory Test Results domain. Supplemental Qualifiers for Respiratory Test Results C147242 Respiratory Test Results Supplemental Qualifiers Dataset
125 2020-03-27 DOMAIN SUPPRP     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Reproductive System Findings domain. Supplemental Qualifiers for Reproductive System Findings C147243 Reproductive System Findings Supplemental Qualifiers Dataset
126 2020-03-27 DOMAIN SUPPRS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Disease Response domain. Supplemental Qualifiers for Disease Response C147244 Disease Response Supplemental Qualifiers Dataset
127 2020-03-27 DOMAIN SUPPSB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Subject Biomarker domain. Supplemental Qualifiers for Subject Biomarker C147245 Subject Biomarker Supplemental Qualifiers Dataset
128 2020-03-27 DOMAIN SUPPSC     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Subject Characteristics domain. Supplemental Qualifiers for Subject Characteristics C147246 Subject Characteristics Supplemental Qualifiers Dataset
129 2020-03-27 DOMAIN SUPPSM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Subject Disease Milestones domain. Supplemental Qualifiers for Subject Disease Milestones C147249 Subject Disease Milestones Supplemental Qualifiers Dataset
130 2020-03-27 DOMAIN SUPPSR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Skin Response domain. Supplemental Qualifiers for Skin Response C147250 Skin Response Supplemental Qualifiers Dataset
131 2020-03-27 DOMAIN SUPPSS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Subject Status domain. Supplemental Qualifiers for Subject Status C147251 Subject Status Supplemental Qualifiers Dataset
132 2020-03-27 DOMAIN SUPPSU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Substance Use domain. Supplemental Qualifiers for Substance Use C147252 Substance Use Supplemental Qualifiers Dataset
133 2020-03-27 DOMAIN SUPPTR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Tumor Response domain. Supplemental Qualifiers for Tumor Response C147261 Tumor Response Supplemental Qualifiers Dataset
134 2020-03-27 DOMAIN SUPPTU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Tumor/Lesion Identification domain. Supplemental Qualifiers for Tumor/Lesion Identification C147264 Tumor/Lesion Identification Supplemental Qualifiers Dataset
135 2020-03-27 DOMAIN SUPPUR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Urinary System Findings domain. Supplemental Qualifiers for Urinary System Findings C147267 Urinary System Findings Supplemental Qualifiers Dataset
136 2020-03-27 DOMAIN SUPPVS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Vital Signs domain. Supplemental Qualifiers for Vital Signs C147268 Vital Signs Supplemental Qualifiers Dataset
137 2020-03-27 DOMAIN SUPPWB     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A dataset used to represent non-standard variables and their association to parent records in the Whole Body Findings domain. Supplemental Qualifiers for Whole Body Findings C147269 Whole Body Findings Supplemental Qualifiers Dataset
138 2020-03-27 DOMAIN SV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A special-purpose domain that contains the actual start and end data/time for each visit of each individual subject. Subject Visits C49617 Subject Visits Domain
139 2020-03-27 DOMAIN TA     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains each planned arm in the trial. Trial Arms C49618 Trial Arms Domain
140 2020-03-27 DOMAIN TD     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that provides information on the protocol-specified disease assessment schedule, to be used for comparison with the actual occurrence of the efficacy assessments in order to determine whether there was good compliance with the schedule. Trial Disease Assessments C117699 Trial Disease Assessments Domain
141 2020-03-27 DOMAIN TE     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains the element code that is unique for each element, the element description, and the rules for starting and ending an element. Trial Elements C49619 Trial Elements Domain
142 2020-03-27 DOMAIN TI     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains one record for each of the inclusion and exclusion criteria for the trial. This domain is not subject oriented. Trial Inclusion/Exclusion Criteria C49620 Trial Inclusion and Exclusion Criteria Domain
143 2020-03-27 DOMAIN TM     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that is used to describe disease milestones, which are observations or activities anticipated to occur in the course of the disease under study, and which trigger the collection of data. Trial Disease Milestones C147270 Trial Disease Milestones Domain
144 2020-03-27 DOMAIN TR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that represents quantitative measurements and/or qualitative assessments of the tumors or lesions identified in the tumor/lesion identification (TU) domain. Tumor/Lesion Results C106578 Tumor Results Domain
145 2020-03-27 DOMAIN TS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented. Trial Summary C53483 Trial Summary Domain
146 2020-03-27 DOMAIN TU     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that represents data that uniquely identifies tumors or lesions under study. Tumor/Lesion Identification C106577 Tumor Identifier Domain
147 2020-03-27 DOMAIN TV     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains the planned order and number of visits in the study within each arm. Trial Visits C49621 Trial Visits Domain
148 2020-03-27 DOMAIN TX     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. This domain is not subject oriented. Trial Sets C95103 Trial Sets Domain
149 2020-03-27 DOMAIN UR     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains physiological and morphological findings related to the urinary tract, including the organs involved in the creation and excretion of urine such as the kidneys, ureters, bladder and urethra. Urinary System Findings C102726 Urinary System Findings Domain
150 2020-03-27 DOMAIN VS     .   C66734 SDTM Domain Abbreviation Yes CDISC SDTM Submission Domain Abbreviation Terminology A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. Vital Signs C49622 Vital Signs Domain

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1 2020-03-27 DOMAIN Single AD       .   C49563 C66734   Yes   SDTM Domain Abbreviation    
2 2020-03-27 DOMAIN Single AE       .   C49562 C66734   Yes   SDTM Domain Abbreviation    
3 2020-03-27 DOMAIN Single AG       .   C117755 C66734   Yes   SDTM Domain Abbreviation    
4 2020-03-27 DOMAIN Single APAE       .   C147168 C66734   Yes   SDTM Domain Abbreviation    
5 2020-03-27 DOMAIN Single APBS       .   C147169 C66734   Yes   SDTM Domain Abbreviation    
6 2020-03-27 DOMAIN Single APDD       .   C147170 C66734   Yes   SDTM Domain Abbreviation    
7 2020-03-27 DOMAIN Single APDM       .   C132354 C66734   Yes   SDTM Domain Abbreviation    
8 2020-03-27 DOMAIN Single APEX       .   C147171 C66734   Yes   SDTM Domain Abbreviation    
9 2020-03-27 DOMAIN Single APLB       .   C147172 C66734   Yes   SDTM Domain Abbreviation    
10 2020-03-27 DOMAIN Single APMH       .   C147173 C66734   Yes   SDTM Domain Abbreviation    
11 2020-03-27 DOMAIN Single APQS       .   C147174 C66734   Yes   SDTM Domain Abbreviation    
12 2020-03-27 DOMAIN Single APRELSUB       .   C147175 C66734   Yes   SDTM Domain Abbreviation    
13 2020-03-27 DOMAIN Single APRP       .   C147176 C66734   Yes   SDTM Domain Abbreviation    
14 2020-03-27 DOMAIN Single APSC       .   C147177 C66734   Yes   SDTM Domain Abbreviation    
15 2020-03-27 DOMAIN Single APSS       .   C147178 C66734   Yes   SDTM Domain Abbreviation    
16 2020-03-27 DOMAIN Single APSU       .   C147179 C66734   Yes   SDTM Domain Abbreviation    
17 2020-03-27 DOMAIN Single AX       .   C111282 C66734   Yes   SDTM Domain Abbreviation    
18 2020-03-27 DOMAIN Single BE       .   C111138 C66734   Yes   SDTM Domain Abbreviation    
19 2020-03-27 DOMAIN Single BS       .   C111137 C66734   Yes   SDTM Domain Abbreviation    
20 2020-03-27 DOMAIN Single CE       .   C85441 C66734   Yes   SDTM Domain Abbreviation    
21 2020-03-27 DOMAIN Single CM       .   C49568 C66734   Yes   SDTM Domain Abbreviation    
22 2020-03-27 DOMAIN Single CO       .   C49569 C66734   Yes   SDTM Domain Abbreviation    
23 2020-03-27 DOMAIN Single CV       .   C102605 C66734   Yes   SDTM Domain Abbreviation    
24 2020-03-27 DOMAIN Single DA       .   C49578 C66734   Yes   SDTM Domain Abbreviation    
25 2020-03-27 DOMAIN Single DD       .   C95087 C66734   Yes   SDTM Domain Abbreviation    
26 2020-03-27 DOMAIN Single DE       .   C102616 C66734   Yes   SDTM Domain Abbreviation    
27 2020-03-27 DOMAIN Single DI       .   C102618 C66734   Yes   SDTM Domain Abbreviation    
28 2020-03-27 DOMAIN Single DM       .   C49572 C66734   Yes   SDTM Domain Abbreviation    
29 2020-03-27 DOMAIN Single DO       .   C102619 C66734   Yes   SDTM Domain Abbreviation    
30 2020-03-27 DOMAIN Single DR       .   C102620 C66734   Yes   SDTM Domain Abbreviation    
31 2020-03-27 DOMAIN Single DS       .   C49576 C66734   Yes   SDTM Domain Abbreviation    
32 2020-03-27 DOMAIN Single DT       .   C102621 C66734   Yes   SDTM Domain Abbreviation    
33 2020-03-27 DOMAIN Single DU       .   C102622 C66734   Yes   SDTM Domain Abbreviation    
34 2020-03-27 DOMAIN Single DV       .   C49585 C66734   Yes   SDTM Domain Abbreviation    
35 2020-03-27 DOMAIN Single DX       .   C102617 C66734   Yes   SDTM Domain Abbreviation    
36 2020-03-27 DOMAIN Single EC       .   C117466 C66734   Yes   SDTM Domain Abbreviation    
37 2020-03-27 DOMAIN Single ED       .   C102630 C66734   Yes   SDTM Domain Abbreviation    
38 2020-03-27 DOMAIN Single EG       .   C49626 C66734   Yes   SDTM Domain Abbreviation    
39 2020-03-27 DOMAIN Single EX       .   C49587 C66734   Yes   SDTM Domain Abbreviation    
40 2020-03-27 DOMAIN Single FA       .   C85442 C66734   Yes   SDTM Domain Abbreviation    
41 2020-03-27 DOMAIN Single FT       .   C117756 C66734   Yes   SDTM Domain Abbreviation    
42 2020-03-27 DOMAIN Single GI       .   C102640 C66734   Yes   SDTM Domain Abbreviation    
43 2020-03-27 DOMAIN Single HM       .   C102641 C66734   Yes   SDTM Domain Abbreviation    
44 2020-03-27 DOMAIN Single HO       .   C117757 C66734   Yes   SDTM Domain Abbreviation    
45 2020-03-27 DOMAIN Single IE       .   C61536 C66734   Yes   SDTM Domain Abbreviation    
46 2020-03-27 DOMAIN Single IG       .   C102651 C66734   Yes   SDTM Domain Abbreviation    
47 2020-03-27 DOMAIN Single IS       .   C112320 C66734   Yes   SDTM Domain Abbreviation    
48 2020-03-27 DOMAIN Single LB       .   C49592 C66734   Yes   SDTM Domain Abbreviation    
49 2020-03-27 DOMAIN Single MB       .   C49602 C66734   Yes   SDTM Domain Abbreviation    
50 2020-03-27 DOMAIN Single MH       .   C49603 C66734   Yes   SDTM Domain Abbreviation    
51 2020-03-27 DOMAIN Single MI       .   C95095 C66734   Yes   SDTM Domain Abbreviation    
52 2020-03-27 DOMAIN Single MK       .   C102674 C66734   Yes   SDTM Domain Abbreviation    
53 2020-03-27 DOMAIN Single ML       .   C49604 C66734   Yes   SDTM Domain Abbreviation    
54 2020-03-27 DOMAIN Single MO       .   C102671 C66734   Yes   SDTM Domain Abbreviation    
55 2020-03-27 DOMAIN Single MS       .   C61531 C66734   Yes   SDTM Domain Abbreviation    
56 2020-03-27 DOMAIN Single NV       .   C102677 C66734   Yes   SDTM Domain Abbreviation    
57 2020-03-27 DOMAIN Single OE       .   C147180 C66734   Yes   SDTM Domain Abbreviation    
58 2020-03-27 DOMAIN Single OI       .   C161329 C66734   Yes   SDTM Domain Abbreviation    
59 2020-03-27 DOMAIN Single PB       .   C106552 C66734   Yes   SDTM Domain Abbreviation    
60 2020-03-27 DOMAIN Single PC       .   C49606 C66734   Yes   SDTM Domain Abbreviation    
61 2020-03-27 DOMAIN Single PE       .   C49608 C66734   Yes   SDTM Domain Abbreviation    
62 2020-03-27 DOMAIN Single PF       .   C111289 C66734   Yes   SDTM Domain Abbreviation    
63 2020-03-27 DOMAIN Single PG       .   C61529 C66734   Yes   SDTM Domain Abbreviation    
64 2020-03-27 DOMAIN Single POOLDEF       .   C147181 C66734   Yes   SDTM Domain Abbreviation    
65 2020-03-27 DOMAIN Single PP       .   C49607 C66734   Yes   SDTM Domain Abbreviation    
66 2020-03-27 DOMAIN Single PR       .   C102700 C66734   Yes   SDTM Domain Abbreviation    
67 2020-03-27 DOMAIN Single QS       .   C49609 C66734   Yes   SDTM Domain Abbreviation    
68 2020-03-27 DOMAIN Single RE       .   C95098 C66734   Yes   SDTM Domain Abbreviation    
69 2020-03-27 DOMAIN Single RELREC       .   C147182 C66734   Yes   SDTM Domain Abbreviation    
70 2020-03-27 DOMAIN Single RELSUB       .   C147183 C66734   Yes   SDTM Domain Abbreviation    
71 2020-03-27 DOMAIN Single RP       .   C102707 C66734   Yes   SDTM Domain Abbreviation    
72 2020-03-27 DOMAIN Single RS       .   C107097 C66734   Yes   SDTM Domain Abbreviation    
73 2020-03-27 DOMAIN Single SB       .   C106571 C66734   Yes   SDTM Domain Abbreviation    
74 2020-03-27 DOMAIN Single SC       .   C49610 C66734   Yes   SDTM Domain Abbreviation    
75 2020-03-27 DOMAIN Single SE       .   C49616 C66734   Yes   SDTM Domain Abbreviation    
76 2020-03-27 DOMAIN Single SM       .   C147184 C66734   Yes   SDTM Domain Abbreviation    
77 2020-03-27 DOMAIN Single SR       .   C112420 C66734   Yes   SDTM Domain Abbreviation    
78 2020-03-27 DOMAIN Single SS       .   C117655 C66734   Yes   SDTM Domain Abbreviation    
79 2020-03-27 DOMAIN Single SU       .   C49615 C66734   Yes   SDTM Domain Abbreviation    
80 2020-03-27 DOMAIN Single SUPPAE       .   C147185 C66734   Yes   SDTM Domain Abbreviation    
81 2020-03-27 DOMAIN Single SUPPAG       .   C147186 C66734   Yes   SDTM Domain Abbreviation    
82 2020-03-27 DOMAIN Single SUPPBE       .   C147187 C66734   Yes   SDTM Domain Abbreviation    
83 2020-03-27 DOMAIN Single SUPPBS       .   C147189 C66734   Yes   SDTM Domain Abbreviation    
84 2020-03-27 DOMAIN Single SUPPCE       .   C147191 C66734   Yes   SDTM Domain Abbreviation    
85 2020-03-27 DOMAIN Single SUPPCM       .   C147193 C66734   Yes   SDTM Domain Abbreviation    
86 2020-03-27 DOMAIN Single SUPPCV       .   C147195 C66734   Yes   SDTM Domain Abbreviation    
87 2020-03-27 DOMAIN Single SUPPDA       .   C147196 C66734   Yes   SDTM Domain Abbreviation    
88 2020-03-27 DOMAIN Single SUPPDD       .   C147197 C66734   Yes   SDTM Domain Abbreviation    
89 2020-03-27 DOMAIN Single SUPPDE       .   C147198 C66734   Yes   SDTM Domain Abbreviation    
90 2020-03-27 DOMAIN Single SUPPDM       .   C147200 C66734   Yes   SDTM Domain Abbreviation    
91 2020-03-27 DOMAIN Single SUPPDO       .   C147201 C66734   Yes   SDTM Domain Abbreviation    
92 2020-03-27 DOMAIN Single SUPPDS       .   C147203 C66734   Yes   SDTM Domain Abbreviation    
93 2020-03-27 DOMAIN Single SUPPDT       .   C147204 C66734   Yes   SDTM Domain Abbreviation    
94 2020-03-27 DOMAIN Single SUPPDU       .   C147205 C66734   Yes   SDTM Domain Abbreviation    
95 2020-03-27 DOMAIN Single SUPPDV       .   C147206 C66734   Yes   SDTM Domain Abbreviation    
96 2020-03-27 DOMAIN Single SUPPDX       .   C147207 C66734   Yes   SDTM Domain Abbreviation    
97 2020-03-27 DOMAIN Single SUPPEC       .   C147208 C66734   Yes   SDTM Domain Abbreviation    
98 2020-03-27 DOMAIN Single SUPPEG       .   C147209 C66734   Yes   SDTM Domain Abbreviation    
99 2020-03-27 DOMAIN Single SUPPER       .   C147210 C66734   Yes   SDTM Domain Abbreviation    
100 2020-03-27 DOMAIN Single SUPPEX       .   C147211 C66734   Yes   SDTM Domain Abbreviation    
101 2020-03-27 DOMAIN Single SUPPFA       .   C147212 C66734   Yes   SDTM Domain Abbreviation    
102 2020-03-27 DOMAIN Single SUPPHO       .   C147216 C66734   Yes   SDTM Domain Abbreviation    
103 2020-03-27 DOMAIN Single SUPPIE       .   C147218 C66734   Yes   SDTM Domain Abbreviation    
104 2020-03-27 DOMAIN Single SUPPIS       .   C147219 C66734   Yes   SDTM Domain Abbreviation    
105 2020-03-27 DOMAIN Single SUPPLB       .   C147220 C66734   Yes   SDTM Domain Abbreviation    
106 2020-03-27 DOMAIN Single SUPPMB       .   C147222 C66734   Yes   SDTM Domain Abbreviation    
107 2020-03-27 DOMAIN Single SUPPMH       .   C147223 C66734   Yes   SDTM Domain Abbreviation    
108 2020-03-27 DOMAIN Single SUPPMI       .   C147224 C66734   Yes   SDTM Domain Abbreviation    
109 2020-03-27 DOMAIN Single SUPPMK       .   C147225 C66734   Yes   SDTM Domain Abbreviation    
110 2020-03-27 DOMAIN Single SUPPML       .   C147226 C66734   Yes   SDTM Domain Abbreviation    
111 2020-03-27 DOMAIN Single SUPPMO       .   C165871 C66734   Yes   SDTM Domain Abbreviation    
112 2020-03-27 DOMAIN Single SUPPMS       .   C147227 C66734   Yes   SDTM Domain Abbreviation    
113 2020-03-27 DOMAIN Single SUPPNV       .   C147228 C66734   Yes   SDTM Domain Abbreviation    
114 2020-03-27 DOMAIN Single SUPPOE       .   C147229 C66734   Yes   SDTM Domain Abbreviation    
115 2020-03-27 DOMAIN Single SUPPPB       .   C147232 C66734   Yes   SDTM Domain Abbreviation    
116 2020-03-27 DOMAIN Single SUPPPC       .   C147233 C66734   Yes   SDTM Domain Abbreviation    
117 2020-03-27 DOMAIN Single SUPPPE       .   C147234 C66734   Yes   SDTM Domain Abbreviation    
118 2020-03-27 DOMAIN Single SUPPPF       .   C147235 C66734   Yes   SDTM Domain Abbreviation    
119 2020-03-27 DOMAIN Single SUPPPG       .   C147236 C66734   Yes   SDTM Domain Abbreviation    
120 2020-03-27 DOMAIN Single SUPPPP       .   C147238 C66734   Yes   SDTM Domain Abbreviation    
121 2020-03-27 DOMAIN Single SUPPPR       .   C147239 C66734   Yes   SDTM Domain Abbreviation    
122 2020-03-27 DOMAIN Single SUPPQS       .   C147240 C66734   Yes   SDTM Domain Abbreviation    
123 2020-03-27 DOMAIN Single SUPPQT       .   C147241 C66734   Yes   SDTM Domain Abbreviation    
124 2020-03-27 DOMAIN Single SUPPRE       .   C147242 C66734   Yes   SDTM Domain Abbreviation    
125 2020-03-27 DOMAIN Single SUPPRP       .   C147243 C66734   Yes   SDTM Domain Abbreviation    
126 2020-03-27 DOMAIN Single SUPPRS       .   C147244 C66734   Yes   SDTM Domain Abbreviation    
127 2020-03-27 DOMAIN Single SUPPSB       .   C147245 C66734   Yes   SDTM Domain Abbreviation    
128 2020-03-27 DOMAIN Single SUPPSC       .   C147246 C66734   Yes   SDTM Domain Abbreviation    
129 2020-03-27 DOMAIN Single SUPPSM       .   C147249 C66734   Yes   SDTM Domain Abbreviation    
130 2020-03-27 DOMAIN Single SUPPSR       .   C147250 C66734   Yes   SDTM Domain Abbreviation    
131 2020-03-27 DOMAIN Single SUPPSS       .   C147251 C66734   Yes   SDTM Domain Abbreviation    
132 2020-03-27 DOMAIN Single SUPPSU       .   C147252 C66734   Yes   SDTM Domain Abbreviation    
133 2020-03-27 DOMAIN Single SUPPTR       .   C147261 C66734   Yes   SDTM Domain Abbreviation    
134 2020-03-27 DOMAIN Single SUPPTU       .   C147264 C66734   Yes   SDTM Domain Abbreviation    
135 2020-03-27 DOMAIN Single SUPPUR       .   C147267 C66734   Yes   SDTM Domain Abbreviation    
136 2020-03-27 DOMAIN Single SUPPVS       .   C147268 C66734   Yes   SDTM Domain Abbreviation    
137 2020-03-27 DOMAIN Single SUPPWB       .   C147269 C66734   Yes   SDTM Domain Abbreviation    
138 2020-03-27 DOMAIN Single SV       .   C49617 C66734   Yes   SDTM Domain Abbreviation    
139 2020-03-27 DOMAIN Single TA       .   C49618 C66734   Yes   SDTM Domain Abbreviation    
140 2020-03-27 DOMAIN Single TD       .   C117699 C66734   Yes   SDTM Domain Abbreviation    
141 2020-03-27 DOMAIN Single TE       .   C49619 C66734   Yes   SDTM Domain Abbreviation    
142 2020-03-27 DOMAIN Single TI       .   C49620 C66734   Yes   SDTM Domain Abbreviation    
143 2020-03-27 DOMAIN Single TM       .   C147270 C66734   Yes   SDTM Domain Abbreviation    
144 2020-03-27 DOMAIN Single TR       .   C106578 C66734   Yes   SDTM Domain Abbreviation    
145 2020-03-27 DOMAIN Single TS       .   C53483 C66734   Yes   SDTM Domain Abbreviation    
146 2020-03-27 DOMAIN Single TU       .   C106577 C66734   Yes   SDTM Domain Abbreviation    
147 2020-03-27 DOMAIN Single TV       .   C49621 C66734   Yes   SDTM Domain Abbreviation    
148 2020-03-27 DOMAIN Single TX       .   C95103 C66734   Yes   SDTM Domain Abbreviation    
149 2020-03-27 DOMAIN Single UR       .   C102726 C66734   Yes   SDTM Domain Abbreviation    
150 2020-03-27 DOMAIN Single VS       .   C49622 C66734   Yes   SDTM Domain Abbreviation