TEMP: domains without a description
All domain codes present TOBA-328 - Getting issue details... STATUS TOBA-141 - Getting issue details... STATUS in content control: AE BW CL CM CO CV DA DD DI DM DO DS DU DV EC EG EM ES EX FA FW GT IE IN IQ IT LB MA MH MI OM PC PD PM POOLDEF PP PT QS RE RELREC RELREF SC SE SU SUPP-- SV TA TE TF TI TO TS TV TX VS
|
Implementation |
SDTM status |
Class |
Domain Code |
Domain Label |
Structure |
Keys* |
C-Code |
Description |
|---|---|---|---|---|---|---|---|---|
| SEND | In SDTM v2.1 | Special-Purpose | CO | Comments | One record per comment | STUDYID, COSEQ | C49569 | A special-purpose domain that contains comments that may be collected alongside other data. |
| SDTM | In SDTM v2.1 | Special-Purpose | CO | Comments | One record per comment per subject | STUDYID, USUBJID, IDVAR, COREF, CODTC | C49569 | A special-purpose domain that contains comments that may be collected alongside other data. |
| SDTM | In SDTM v2.1 | Special-Purpose | DM | Demographics | One record per subject | STUDYID, USUBJID | C49572 | A special-purpose domain that includes a set of essential standard variables that describe each subject in study. One record will exist for each subject. |
| SEND | In SDTM v2.1 | Special-Purpose | DM | Demographics | One record per subject | STUDYID, USUBJID | C49572 | A special-purpose domain that includes a set of essential standard variables that describe each subject in a nonclinical study. One record will exist for each subject. |
| SDTM | Not in SDTM v2.1 | Special-Purpose | IQ | Ingredient Quantities by Component | One record per ingredient/component (IGDCMPID) per parent ingredient/component | A special purpose domain for representing the quantity of an ingredient/component of a product by the parent ingredient/component in which it occurs. | ||
| SDTM | Not in SDTM v2.1 | Special-Purpose | IN | Non-Tobacco Ingredients | One record per unique non-tobacco ingredient per applicant-defined tobacco product | STUDYID, SPTOBID, IGDCMPID | A special-purpose domain that provides an identifier for each unique non-tobacco ingredient (IGDCMPID) in a tobacco product, and lists those ingredients and their attributes that contribute to their uniqueness. | |
| SDTM | Not in SDTM v2.1 | Special-Purpose | PD | Product Design Parameters | One record per parameter code per unit of measure per applicant-defined tobacco product | A special-purpose domain that lists the target, minimum, and maximum allowable values for design parameters of a product as allowed per manufacturer specifications. Therefore these data are not experimentally determined. | ||
| SEND | In SDTM v2.1 | Special-Purpose | SE | Subject Elements | One record per element experienced per subject | STUDYID, USUBJID, ETCD, SESTDTC | C49616 | 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. |
| SDTM | In SDTM v2.1 | Special-Purpose | SE | Subject Elements | One record per actual Element per subject | STUDYID, USUBJID, ETCD, SESTDTC | C49616 | 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. |
| SDTM | In SDTM v2.1 | Special-Purpose | SV | Subject Visits | One record per actual or planned visit per subject | STUDYID, USUBJID, SVTERM | C49617 | A special-purpose domain that contains information for each subject's actual and planned visits and contact events. |
| SDTM | Not in SDTM v2.1 | Special-Purpose | IT | Tobacco Ingredients | One record per unique tobacco ingredient per applicant-defined tobacco product | STUDYID, SPTOBID, IGDCMPID | A special-purpose domain that provides an identifier for each unique tobacco ingredient (IGDCMPID) in a tobacco product, and lists those tobacco ingredients and their attributes that contribute to their uniqueness. | |
| SDTM | In SDTM v2.1 | Interventions | CM | Concomitant/Prior Medications | One record per recorded intervention occurrence or constant-dosing interval per subject | STUDYID, USUBJID, CMTRT, CMSTDTC | C49568 | 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. |
| SDTM | In SDTM v2.1 | Interventions | EX | Exposure | One record per protocol-specified study product, constant-dosing interval, per subject | STUDYID, USUBJID, EXTRT, EXSTDTC | C49587 | An interventions domain that contains the details of a subject's exposure to protocol-specified study products. A study product 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. |
| SEND | In SDTM v2.1 | Interventions | EX | Exposure | One record per protocol-specified study product per constant-dosing interval per subject or pool | STUDYID, USUBJID or POOLID, EXTRT, EXSTDTC | C49587 | An interventions domain that contains the details of a subject's exposure to protocol-specified study products. A study product 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. |
| SDTM | In SDTM v2.1 | Interventions | EC | Exposure as Collected | One record per protocol-specified study product, collected-dosing interval, per subject, per mood | STUDYID, USUBJID, ECTRT, ECSTDTC, ECMOOD | C117466 | An interventions domain that contains information about protocol-specified study product administrations, as collected. |
| SDTM | In SDTM v2.1 | Interventions | SU | Substance Use | One record per substance type per reported occurrence per subject | STUDYID, USUBJID, SUTRT, SUSTDTC | C49615 | An interventions domain that contains information on the use of recreational products such as caffeine, alcohol, tobacco/nicotine, and other recreational drugs that may be of interest to the study. |
| SDTM | In SDTM v2.1 | Events | AE | Adverse Events | One record per adverse event per subject | STUDYID, USUBJID, AEDECOD, AESTDTC | C49562 | An events domain used for data describing unintended signs, symptoms, or diseases temporally associated with the defined study period. |
| SDTM | In SDTM v2.1 | Events | DS | Disposition | One record per disposition status or protocol milestone per subject | STUDYID, USUBJID, DSDECOD, DSSTDTC | C49576 | An events domain that contains information encompassing and representing data related to subject disposition. |
| SEND | In SDTM v2.1 | Events | DS | Disposition | One record per subject | STUDYID, USUBJID | C49576 | An events domain that contains information encompassing and representing data related to subject disposition. |
| SDTM | In SDTM v2.1 | Events | MH | Medical History | One record per medical history event per subject | STUDYID, USUBJID, MHDECOD | C49603 | An events domain that contains data that includes the subject's prior medical history at the start of the trial. |
| SDTM | In SDTM v2.1 | Events | DV | Protocol Deviations | One record per protocol deviation per subject | STUDYID, USUBJID, DVTERM, DVSTDTC | C49585 | An events domain that contains protocol violations and deviations during the course of the study. |
| SDTM | In SDTM v2.1 | Events | EM | Tobacco Product Events and Malfunctions | One record per event or malfunction per tobacco product device | An events domain for representing tobacco product device events, issues, and malfunctions that may occur during its use or testing. Since events may or may not be associated with a subject, USUBJID is a permissible variable. | ||
| SEND | In SDTM v2.1 | Findings | BW | Body Weights | One record per test per observation time per subject | STUDYID, USUBJID, BWTESTCD, BWDTC | C95085 | This domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights). |
| SEND | In SDTM v2.1 | Findings | CV | Cardiovascular System Findings | One record per test per observation time or evaluation interval per subject | STUDYID, USUBJID, CVTESTCD, CVTPTREF, CVTPTNUM | C102605 | A findings domain that contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. |
| SEND | In SDTM v2.1 | Findings | CL | Clinical Observations | One record per finding per observation time per subject or pool | STUDYID, USUBJID or POOLID, CLTESTCD, CLCAT, CLORRES, CLLOC, CLDTC | C95086 | This domain captures clinical sign information including ophthalmology, physical examination, and dermal examination collected in life while executing the study. |
| SEND | In SDTM v2.1 | Findings | DD | Death Diagnosis and Details | One record per diagnosis per subject (for unscheduled deaths only) | STUDYID, USUBJID, DDORRES | C95087 | A findings domain that contains the diagnosis of the cause of death for a subject. |
| SDTM | In SDTM v2.1 | Findings | DO | Device Properties | One record per property per device, Tabulation | C102619 | A findings domain that contains the device characteristics that do not vary over the course of the study. | |
| SDTM | In SDTM v2.1 | Findings | DU | Device-in-Use | One record per property or setting per time point per visit or test date per subject | STUDYID, USUBJID, DUTESTCD, VISITNUM or DUDTC, DUTPTREF | C102622 | 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. |
| SEND | In SDTM v2.1 | Findings | DU | Device-in-Use | One record per property or setting per time point per visit or test date per subject | STUDYID, USUBJID, DUTESTCD, VISITNUM or DUDTC, DUTPTREF | C102622 | 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. |
| SDTM | In SDTM v2.1 | Findings | EG | ECG Test Results | One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject | STUDYID, USUBJID, EGTESTCD, VISITNUM, EGTPTREF, EGTPTNUM | C49626 | 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. |
| SEND | In SDTM v2.1 | Findings | EG | ECG Test Results | One record per test per observation time per subject | STUDYID, USUBJID, EGTESTCD, VISITNUM, EGTPTREF, EGTPTNUM | C49626 | 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. |
| SEND | In SDTM v2.1 | Findings | FW | Food and Water Consumption | One record per test per interval per subject or pool | STUDYID, USUBJID or POOLID, FWTESTCD, FWDTC, FWENDTC | C95090 | This domain captures food/water consumption of animals in the study. The data in this domain is derived data. |
| SEND | In SDTM v2.1 | Findings | GT | Genetic Toxicology In Vitro Test Results | One record per information source per test per summary result type per run | STUDYID, REFID, GTTESTCD, GTRUNID, GTCOLSRT | A findings domain that contains in vitro genetic toxicology test results. | |
| SDTM | In SDTM v2.1 | Findings | IE | Inclusion/Exclusion Criteria Not Met | One record per inclusion/exclusion criterion not met per subject | STUDYID, USUBJID, IETESTCD | C61536 | A findings domain that contains those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. |
| SDTM | In SDTM v2.1 | Findings | LB | Laboratory Test Results | One record per lab test per time point per visit per subject | STUDYID, USUBJID, LBTESTCD, LBSPEC, VISITNUM, LBTPTREF, LBTPTNUM | C49592 | 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. |
| SEND | In SDTM v2.1 | Findings | LB | Laboratory Test Results | One record per test per specimen per observation time per subject or pool | STUDYID, USUBJID or POOLID, LBTESTCD, LBSPEC, LBDTC, LBTPTNUM | C49592 | 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. |
| SEND | In SDTM v2.1 | Findings | MA | Macroscopic Findings | One record per finding per specimen per subject | STUDYID, USUBJID, MATESTCD, MAORRES, MASPEC, MAANTREG, MALAT, MADIR | C95094 | The gross pathology findings recorded at necropsy. |
| SEND | In SDTM v2.1 | Findings | MI | Microscopic Findings | One record per finding per specimen per subject | STUDYID, USUBJID, MITESTCD, MISTRESC, MISPEC, MIANTREG, MILAT, MIDIR | C95095 | A findings domain that contains histopathology findings and microscopic evaluations. |
| SEND | In SDTM v2.1 | Findings | OM | Organ Measurements | One record per test per specimen per subject | STUDYID, USUBJID, OMTESTCD, OMSPEC, OMANTREG, OMLAT, OMDIR | C49605 | Findings from organ measurement evaluations. |
| SEND | In SDTM v2.1 | Findings | PM | Palpable Masses | One record per test per palpable mass per observation time per subject | STUDYID, USUBJID, PMTESTCD, PMSPID, PMDTC | C95097 | This domain captures information of any palpable masses examined during the experimental phase. |
| SDTM | In SDTM v2.1 | Findings | PC | Pharmacokinetics Concentrations | One record per sample characteristic or time-point concentration per reference time point or per analyte per subject | STUDYID, USUBJID, PCTESTCD, VISITNUM, PCTPTREF, PCTPTNUM | C49606 | A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time. |
| SEND | In SDTM v2.1 | Findings | PC | Pharmacokinetics Concentrations | One record per test per specimen per observation time per subject or pool | STUDYID, USUBJID, PCTESTCD, PCSPEC, PCNOMDY, PCELTM, PCTPTREF | C49606 | A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time. |
| SDTM | In SDTM v2.1 | Findings | PP | Pharmacokinetics Parameters | One record per PK parameter per time-concentration profile per modeling method per subject | STUDYID, USUBJID, PPTESTCD, PPCAT, VISITNUM, PPRFTDTC | C49607 | A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. |
| SEND | In SDTM v2.1 | Findings | PP | Pharmacokinetics Parameters | One record per PK parameter per time-concentration profile per modeling method per subject or pool | STUDYID, USUBJID, PPTESTCD, PPCAT, PPSPEC, PPNOMDY, PPTPTREF | C49607 | A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. |
| SDTM | In SDTM v2.1 | Findings | DA | Product Accountability | One record per product accountability finding per subject | STUDYID, USUBJID, DATESTCD, DADTC | C49578 | A findings domain that contains the accountability of study product, such as information on the receipt, dispensing, return, and packaging. |
| SDTM | In SDTM v2.1 | Findings | QS | Questionnaires | One record per questionnaire per question per time point per visit per subject | STUDYID, USUBJID, QSCAT, QSSCAT, VISITNUM, QSTESTCD | C49609 | 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. |
| SDTM | In SDTM v2.1 | Findings | RE | Respiratory System Findings | One record per finding or result per time point per visit per subject | STUDYID, USUBJID, VISITNUM, RETESTCD, RETPTNUM, REREPNUM | C95098 | 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. |
| SEND | In SDTM v2.1 | Findings | RE | Respiratory System Findings | One record per test per observation time or evaluation interval per subject | STUDYID, USUBJID, RETESTCD, REDTC, RETPT | C95098 | 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. |
| SDTM | In SDTM v2.1 | Findings | SC | Subject Characteristics | One record per characteristic per visit per subject. | STUDYID, USUBJID, SCTESTCD, VISITNUM | C49610 | A findings domain that contains subject-related data not collected in other domains. |
| SEND | In SDTM v2.1 | Findings | SC | Subject Characteristics | One record per characteristic per subject | STUDYID, USUBJID, SCTESTCD | C49610 | A findings domain that contains subject-related data not collected in other domains. |
| SDTM | In SDTM v2.1 | Findings | PT | Tobacco Product Testing | One record per test, per replicate, per timepoint, per tobacco product | A findings domain for representing results of testing performed on tobacco products or samples from tobacco products. PT is not a subject-level domain and is not used for results from testing products in human or animal subjects. | ||
| SEND | In SDTM v2.1 | Findings | TF | Tumor Findings | One record per tumor per specimen per subject | STUDYID, USUBJID, TFTESTCD, TFORRES, TFSPEC, TFANTREG, TFLAT, TFDIR | A findings domain that captures the post-mortem tumor findings of the study. Records in this domain are a subset of the records in the Microscopic Findings (MI) domain. | |
| SDTM | In SDTM v2.1 | Findings | VS | Vital Signs | One record per vital sign measurement per time point per visit per subject | STUDYID, USUBJID, VSTESTCD, VISITNUM, VSTPTREF, VSTPTNUM | C49622 | A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. |
| SEND | In SDTM v2.1 | Findings | VS | Vital Signs | One record per measurement per observation time per subject | STUDYID, USUBJID, VSTESTCD, VSDTC, VSTPT | C49622 | A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. |
| SDTM | In SDTM v2.1 | Findings About | FA | Findings About Events or Interventions | One record per finding, per object, per time point, per visit per subject | STUDYID, USUBJID, FATESTCD, FAOBJ, VISITNUM, FATPTREF, FATPTNUM | C85442 | 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. |
| SDTM | In SDTM v2.1 | Trial Design | TA | Trial Arms | One record per planned Element per Arm | STUDYID, ARMCD, TAETORD | C49618 | A trial design domain that contains each planned arm in the trial. |
| SEND | In SDTM v2.1 | Trial Design | TA | Trial Arms | One record per planned Element per Arm | STUDYID, ARMCD, TAETORD | C49618 | A trial design domain that contains each planned arm in the trial. |
| SDTM | In SDTM v2.1 | Trial Design | TE | Trial Elements | One record per planned Element | STUDYID, ETCD | C49619 | 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. |
| SEND | In SDTM v2.1 | Trial Design | TE | Trial Elements | One record per planned Element | STUDYID, ETCD | C49619 | 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. |
| SDTM | In SDTM v2.1 | Trial Design | TI | Trial Inclusion/Exclusion Criteria | One record per I/E criterion | STUDYID, IETESTCD | C49620 | 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. |
| SEND | In SDTM v2.1 | Trial Design | TX | Trial Sets | One record per Trial Set parameter per Trial Set | STUDYID, SETCD, TXPARMCD | C95103 | A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct applicant designations. This domain is not subject oriented. |
| SDTM | In SDTM v2.1 | Trial Design | TS | Trial Summary | One record per trial summary parameter value | STUDYID, TSPARMCD, TSSEQ | C53483 | A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented. |
| SEND | In SDTM v2.1 | Trial Design | TS | Trial Summary | One record per trial summary parameter value | STUDYID, TSPARMCD, TSSEQ | C53483 | A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented. |
| SDTM | In SDTM v2.1 | Trial Design | TV | Trial Visits | One record per planned Visit per Arm | STUDYID, ARM, VISIT | C49621 | A trial design domain that contains the planned order and number of visits in the study within each arm. |
| SEND | In SDTM v2.1 | Relationship | POOLDEF | Pool Definition | One record per subject per pool | STUDYID, USUBJID, POOLID | C147181 | A dataset that identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured. |
| SDTM | In SDTM v2.1 | Relationship | RELREC | Related Records | One record per related record, group of records or dataset | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID | C147182 | A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. |
| SEND | In SDTM v2.1 | Relationship | RELREC | Related Records | One record per related record, related group of records (e.g.,--GRPID), or related dataset | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID | C147182 | A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. |
| SEND | In SDTM v2.1 | Relationship | RELREF | Related References | One record per Reference ID | STUDYID, REFID | A relationship dataset used to describe how information is related to the design of the study and to other sources of information within the study. | |
| SDTM | In SDTM v2.1 | Relationship | SUPP-- | Supplemental Qualifiers for [domain name] | One record per supplemental qualifier per related parent domain record(s) | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | A relationship dataset used to describe nonstandard variables and their association to parent records in general-observation class datasets. | |
| SEND | In SDTM v2.1 | Relationship | SUPP-- | Supplemental Qualifiers for [domain name] | One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | A relationship dataset used to describe nonstandard variables and their association to parent records in general-observation class datasets. | |
| SDTM | In SDTM v2.1 | Study Reference | DI | Device Identifiers | One record per device identifier per device | STUDYID, SPDEVID | C102618 | A study reference dataset that provides a mechanism for using multiple identifiers to create a single identifier for each device. |
| SEND | In SDTM v2.1 | Study Reference | DI | Device Identifiers | One record per device identifier per device | STUDYID, SPDEVID | C102618 | A study reference dataset that provides a mechanism for using multiple identifiers to create a single identifier for each device. |
| SDTM | Not in SDTM v2.1 | Study Reference | ES | Environmental Storage Conditions | One record per parameter code per defined set of storage conditions | A study reference dataset that provides a consistent identifier (STOCONID) for the representation of a set of environmental conditions under which a test article is stored, and contains a list of those conditions. | ||
| SDTM | Not in SDTM v2.1 | Study Reference | TO | Tobacco Product Identifiers and Descriptors | One record per parameter code per applicant-defined tobacco product | A study reference dataset that provides a consistent identifier (SPTOBID) for the representation of a tobacco product. The dataset contains a list of the identifying and descriptive characteristics of the tobacco product. |
74 domains (dataset specifications) total.
- 36 SDTM datasets (excluding trial design)
- 29 SEND datasets (excluding trial design)
- 6 unique trial design datasets (9 counting doubles)
Overview
Content Tools