Information for Reviewers
Batch 1
The variables defined in Batch 1 were based on SDTM v1.4 and the CDASHIG v1.0. The variables were from the SDTM tables for general observation classes and the SDTM table for the Demographics domain, plus CDASH variables for the Demographics domain. Some variables were put on hold in Batch 1. The complete set of variables defined in Batch 1 is in SDTM Variable Definitions - COMPLETED 2019 Review,
Root Variables
Definitions were agreed for root variables, rather than domain-specific variables. For general observation class domains, all the variables that appear in the general observation class tables (Timing, Identifiers, Findings, Findings About, Events, and Interventions) are considered root variables, whether they start with two hyphens or not. The identifiers for AP domains are also considered root variables. In other SDTM tables, variables that start with the domain code are considered instantiations of a root variable with a name that starts with two hyphens in place of the the domain code, although there are a few exceptions, described below. Some of those root variables are included in the general observation class tables. For example, DISEQ is considered an instantiation of the general observation class variable --SEQ. Other root variables never explicitly appear in the SDTM with a two-hyphen name. For instance, TSPARM, TXPARM, ACPARM, DIPARM, and OIPARM are all considered instantiations of the root variable --PARM, although the text of the SDTM does not include the charater string "--PARM". Variables in the non-general observation class domains include many that do not start with a two-character domain code. Some of these are root variables in the general observation class domains (e.g., STUDYID, VISIT), while others are considered root variables, whether they appear in a single domain (e.g., LEVEL and PARENT in RELSPEC) or in multiple domains (e.g., IDVAR, IDVARVAL).
There are exceptions to the general pattern:
- The variables IETESTCD, IETEST, IECAT, and IESCAT in the TI domain do not start with the domain code "TI", so would appear to be root variables. However, they are considered to be instantiations of the root variables --TESTCD, --TEST, --CAT, and --SCAT respectively.
- The variable SPEC in RELSPEC does not start with a two-letter domain code (RELSPEC doesn't have a two-letter domain code), but is nevertheless considered to be an instantiation of the root variable --SPEC.
- The variable TAETORD in TA starts with the two-letter domain code, but is nevertheless considered to be an instantiation of the timing variable TAETORD in the general observation classes,
Batch 2
Batch 2 includes variables from all the SDTM v2.0 tables, even though SDTM v2.0 has not yet been released. Variables which were defined in Batch 1 and which do not appear outside the scope of Batch 1 (general observation class variables and Demographics) are not in Batch 2.
- Table 1 includes definitions for variables which were not included in Batch 1 or were placed on hold in Batch 1.
- Table 2 includes variable definitions in Batch 1 for variables which appear in additional SDTM tables, and which were unchanged in the broader scope of Batch 2.
- Table 3 includes variable definitions which were included in Batch 1, but were updated in Batch 2. Many changes were due to the expanded scope (additional SDTM tables) of Batch 2.
Table 1. Root variable definitions added in Batch 2
| Root Variable Name | Variable Label | Variable C-code | Definition | Notes | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ACTARMUD | Description of Unplanned Actual Arm | A description of the pathway through the study for a subject who did not follow one of the planned trial arms. | A description of actual treatment for a subject who did not receive treatment described in one of the planned trial arms. | DM | |||||||
| --AGENT | Agent Name | The name of the drug or other material to which susceptibility is tested. | The name of the drug or other material for which resistance is tested. The agent may be used for in vitro testing or may be used in tests for genetic markers or in direct phenotypic drug-sensitivity testing. | Findings-General | |||||||
| --ANCVAR | Anchor Variable Name | The name of a variable that specifies the fixed reference point for the start of the planned assessment schedule. | A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be referenced from the ADaM subject-level (ADSL) dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference date variable name. | TD | |||||||
| --ANMETH | Analysis Method | The name of an algorithm, formula or calculation used to obtain a result from intermediate data. | Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). | Findings-General | |||||||
| APID | Associated Persons Identifier | A sequence of characters used to uniquely identify a single associated person, a group of associated persons, or a pool of associated persons. | POOLDEF: Identifier for a single associated person, a group of associated persons, or a pool of associated persons. RELREC: Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. SUPPQUAL: Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. APRELSUB: Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. Assoicated Persons: Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. | All Classes-General | POOLDEF, RELREC, SUPPQUAL, APRELSUB | Associated Persons | |||||
| ARMNRS | Reason Arm and/or Actual Arm is Null | The explanation for why the actual and/or planned arm variables are not populated. | The reason why the actual arm variables are null or why both the planned and actual arm variables are null. It is assumed that if the arm and actual arm variables are null, the same reason applies to both. | DM | |||||||
| --BDAGNT | Binding Agent | The textual description of the agent that's binding to the entity in the --TEST variable. | The textual description of the agent that's binding to the entity in the --TEST variable. The --BDAGNT variable is used to indicate that there is a binding relationship between the entities in the --TEST and --BDAGNT variables, regardless of direction. --BDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the two entities in --TEST and --BDAGNT. In other words, the combination of --TEST and --BDAGNT should describe the thing, the entity, or the analyte being measured, without the need for additional variables. The binding agent may be, but is not limited to, a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent. | Findings-General | |||||||
| --BEATNO | ECG Beat Number | A numeric identifier that indicates the relative temporal position of an ECG beat. | A sequence number that identifies the beat within an ECG. | All Classes-General | |||||||
| --BRANCH | Branch | A decision point condition which determines, in whole or in part, the subject's assignment to an arm and thus their transition to the subsequent element. | TA: Condition subjects meet, at a "branch" in the trial design at the end of this element, to be included in this arm. TP: Conditions subjects meet, occurring at the end of a repro stage, which cause a repro path to branch off from another repro path. | TA, TP | |||||||
| CETHNIC | Collected Ethnicity | An operational field for collecting ethnicity. | A social group characterized by a distinctive social and cultural tradition that is maintained from generation to generation. Members share a common history and origin and a sense of identification with the group. They have similar and distinctive features in their lifestyle habits and shared experiences. They often have a common genetic heritage which may be reflected in their experience of health and disease. When submitting to the FDA, the collected values must be rolled up to the permissible values in ETHNIC. | DM | |||||||
| --CHDY | Day of Obs Rel to Challenge Agent | The number of days from the first date of challenge agent exposure to the date of collection (--DTC), used in study data tabulation. | The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --CHENDY | End Day of Obs Rel to Challenge Agent | The number of days from the first date of challenge agent exposure to the end of an intervention or event (--ENDTC), used for study data tabulation. | The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --CHRON | Chronicity of Finding | Characterization of the time course of a biological process, which qualifies a particular finding. | Characterization of the duration of a biological process resulting in a particular finding. | Findings-General | |||||||
| --CHSTDY | Start Day of Obs Rel to Challenge Agent | The number of days from the first date of challenge agent exposure to the start of an intervention or event (--STDTC), used for study data tabulation. | he actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | All Classes-General | |||||||
| --COLSRT | Collected Summary Result Type | Indicates the statistical or mathematical property of a collected summary result. | Used to indicate the type of a collected summary result. This is used for summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived by the sponsor using individual source data records, the summary result is represented in ADaM. If a sponsor has both a collected or vendor-provided summary result and a derived summary result, the collected or vendor-provided summary result is represented in SDTM and the derived summary result is represented in ADaM. | Findings-General | |||||||
| --CONC | Agent Concentration | The amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | The amount of drug or other material listed in MSAGENT per unit volume or weight. Used when the agent is part of the prespecified test. Not to be used when the concentration is a result of a test such as minimal inhibitory concentration, IC50, or EC50. | Findings-General | |||||||
| --CONCU | Agent Concentration Units | The unit of measure for the amount, per unit volume or weight, of the drug or other material to which susceptibility is tested. | Unit of measure for MSCONC. | Findings-General | |||||||
| CRACE | Collected Race | An operational field for collecting race. | An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control). | DM | |||||||
| --DEF | Disease Milestone Definition | The description of an event or activity that can be anticipated in the course of a disease, but whose timing is not controlled by the study schedule. | Definition of the disease milestone. | TM | |||||||
| --DIR | Directionality | An anatomical qualifier that describes the relative location or orientation of a part of the body. | Qualifier for anatomical location or specimen further detailing directionality. | Findings-General Interventions-General Events-General | |||||||
| --DISTR | Distribution Pattern of Finding | A description of the arrangement or dissemination of a finding within an area of focus. | Description of the distribution pattern of a finding within the examined area. | Findings-General | |||||||
| ELEMENT | Description of Element | A descriptive name for a block of time within one or more arms, wherein protocol-defined activities take place. | SE: The name of the element. If ETCD has a value of "UNPLAN" then ELEMENT should be null. TE: The name of the element. TA: The name of the element. | SE | TE, TA | ||||||
| --ENRL | TE: Rule for End of Element TT: Rule for End of Repro Stage TV: Visit End Rule | Identifies the condition or criterion that defines the end of a planned period of time within the study. | TE: Expresses the rule for ending the element. Either TEENRL or TEDUR must be present for each element. TT: Expresses the rule for ending the repro stage. Either TTENRL or TTDUR must be present for each repro stage. TV: Rule describing when the visit ends, in relation to the sequence of elements. | TE, TT, TV | |||||||
| ETCD | Element Code | A short sequence of characters that represents the trial element. | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. | SE | TE, TA | ||||||
| ETHNIC | Ethnicity | An arbitrary classification of the social group a person belongs to, and either identifies with or is identified with by others, as a result of a complex of cultural, biological, geographical and other factors. | The ethnicity of the subject. Sponsors should refer to FDA guidance regarding the collection of ethnicity data. | DM | |||||||
| --EVDTYP | Medical History Event Date Type | A description of a state, stage or instance of a medical history event to which distinct timing applies. | Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. | Events-General | |||||||
| FOCID | Focus of Study-Specific Interest | A sequence of characters used to uniquely identify the protocol-specified discrete part of a subject or specimen (the experimental unit) where the measurement, test, intervention, or examination was performed. | Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed. The value in this variable should have inherent semantic meaning. | All Classes-General | |||||||
| --FTDOSD | Factor for Toxic/Physiologic Dose Descr | The quantity given for the multiplier of the toxicological/physiological dose description (--TDOSD). | The quantity given for the multiplier of --TDOSD. | Interventions-General | |||||||
| IDVAR | Identifying Variable | A variable that contains the name of an operational variable, used in combination with other identifier variables, that is used in specifying records that are related. | CO: Identifying variable in the parent dataset that identifies the record(s) to which the comment applies (e.g., AESEQ, CMGRPID). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. RELREC: Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). SUPPQUAL: Identifying variable in the parent dataset that identifies the related record(s). | CO | RELREC, SUPPQUAL | ||||||
| IDVARVAL | Identifying Variable Value | A variable that contains the value of the operational variable, used in combination with other identifier variables, that is used in specifying records that are related. | CO: Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs. RELREC: Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ is entered here. SUPPQUAL: Value of identifying variable of the parent record(s). | CO | RELREC, SUPPQUAL | ||||||
| --IMPLBL | Implantation Site Label | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn). | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study. | Findings-General | |||||||
| INVID | Investigator Identifier | A sequence of characters used to uniquely identify the investigator. | An identifier to describe the Investigator for the study. May be used in addition to the SITEID. Not needed if SITEID is equivalent to INVID. | DM | |||||||
| INVNAM | Investigator Name | The name of the investigator. | Name of the investigator for a site. | DM | |||||||
| --LAT | Laterality | Referring to the side or sides of the body, or part of the body, relevant to the anatomical location of the intervention, event, or assessment. | Qualifier for anatomical location or specimen further detailing laterality. | Events-General Findings-General Interventions-General | |||||||
| LEVEL | Specimen Level | The generation number of a biospecimen in relation to the collected biospecimen that is considered the first generation. | Identifies the generation number of the sample where the collected sample is considered the first generation. | RELSPEC | |||||||
| --LLOD | Lower Limit of Detection | The lowest threshold (as originally received or collected) for reliably detecting the presence of a substance measured by a specific test. | The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. Units will be those used for --ORRESU. | Findings-General | |||||||
| --LOBXFL | Last Observation Before Exposure Flag | An indication that the record is the last non-missing baseline assessment prior to the date and time in RFXSTDTC. | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. | Findings-General | |||||||
| --LOC | Findings: Location Used for the Measurement Interventions: Location of Administration Events: Location of Event | The anatomical location of the intervention, event, or assessment. | Findings: Anatomical location of the subject relevant to the collection of the measurement. Interventions: Anatomical location of an intervention, such as an injection site. Events: Describes anatomical location relevant for the event. | Findings-General Interventions-General Events-General | |||||||
| --MAXPAI | Planned Assessment Interval Maximum | The upper limit of the allowed range for the interval between disease assessments in the planned assessment schedule, represented in a standardized character format. | The upper limit of the allowed range for the planned interval between disease assessments. | TD | |||||||
| MIDS | Disease Milestone Instance Name | A sequence of characters used to uniquely identify a single occurrence of a disease milestone. | The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset. This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. SM: Name of the specific disease milestone. For disease milestones that can occur multiple times, the name will end with a sequence number. | All Classes-General | SM | ||||||
| MIDSDTC | Disease Milestone Instance Date/Time | The start date or date and time of the disease milestone instance, represented in a standardized character format. | The start date/time of the Disease Milestone Instance Name in MIDS. | All Classes-General | |||||||
| MIDSTYPE | Disease Milestone Type | A short description of a disease milestone. | The type of disease milestone. | SM | TM | ||||||
| --MINPAI | Planned Assessment Interval Minimum | The lower limit of the allowed range for the interval between disease assessments in the planned assessment schedule, represented in a standardized character format. | The lower limit of the allowed range for the planned interval between disease assessments. | TD | |||||||
| --TMTHSN | Test Method Sensitivity | A description of the relative ability of a test methodology to detect or quantify small amounts of a substance. | The sensitivity of the test methodology with respect to observation, detection, or quantification. | Findings-General | |||||||
| NHOID | Non-Host Organism Identifier | A sequence of characters used to uniquely identify a non-host organism. | Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab. OI: Sponsor-defined identifier for a non-host organism. | All Classes-General | OI | ||||||
| --NUMRPT | Maximum Number of Actual Assessments | The planned number of assessments in the assessment schedule, or, if the number of assessments is not limited in the protocol, the maximum number of assessments that actually occurred. | This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g., assessments occur until death), TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis, encountered by any subject across the trial at that point in time. | TD | |||||||
| --OBJ | Object of the Observation | Names the event or intervention whose property is being measured, tested, or examined. | Used in domains modeled as Findings About Events or Findings About Interventions. Describes the event or intervention whose property is being measured in --TESTCD/--TEST. | Findings About-Findings | |||||||
| --ORDER | Sequence of Planned Assessment Schedule | An assigned numeric identifier that gives the order of the planned assessment schedule within the trial. | A number given to ensure ordinal sequencing of the planned assessment schedules within a trial. | TD | |||||||
| --ORREF | Reference Result in Original Units | Reference value for the result (as originally received or collected) of the measurement, test, or examination. | Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. | Findings-General | |||||||
| PARENT | Specimen Parent | The identifier for the immediate progenitor of a biospecimen. | Identifies the REFID of the parent of a specimen to support tracking its genealogy. | RELSPEC | |||||||
| --PARM | TS: Trial Summary Parameter TX: Trial Set Parameter AC: Challenge Agent Parameter DI: Device Identifier Element Name OI: Non-Host Organism ID Element Name | The standardized or dictionary-derived name of an attribute for the topic of the domain. | TS: Term for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters. TX: Term for the trial set parameter. Maximum 40 characters. AC: Term for the challenge agent characterization parameter. The value in ACPARM cannot be longer than 40 characters. DI: Name of the identifier characteristic of the device. OI: Value for the taxon in OIPARMCD/OIPARM for the organism identified by NHOID. | TS, TX, AC | DI, OI | ||||||
| --PARMCD | TS: Trial Summary Parameter Short Name TX: Trial Set Parameter Short Name AC: Challenge Agent Parameter Short Name DI: Device Identifier Element Name OI: Non-Host Organism ID Element Name | A standardized or dictionary-derived short sequence of characters used to represent an attribute for the topic of the domain. | TS: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. TX: Short character value for the trial Sset parameter described in TXPARM. Maximum 8 characters. AC: ACPARMCD (the companion to ACPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ACPARMCD will need to serve as variable names. DI: Name of the identifier characteristic of the device OI: Name of the taxon being described. | TS, TX, AC | DI, OI | ||||||
| --PDUR | Planned Duration | The length of time during which an observation is planned to continue, represented in a standardized character format. | Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection. | All Classes-General | |||||||
| --PORTOT | Portion or Totality | Describes a portion of or the totality of an entity of the body, or part of the body, or of a tissue specimen. | Qualifier for anatomical location or specimen further detailing the distribution (i.e., arrangement or apportioning of). | Events-General Findings-General Interventions-General | |||||||
| --PTFL | Point in Time Flag | An indication that the assessment was done, or the specimen or data was collected, at a single point in time. | An indication that the specimen was collected at a single point in time. The value is "Y" or null. | All Classes-General | |||||||
| QEVAL | Evaluator | The role of the person(s) providing the value of the non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | 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. | SUPPQUAL | |||||||
| QLABEL | Qualifier Variable Label | The long name of a non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | 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. | SUPPQUAL | |||||||
| QNAM | Qualifier Variable Name | The short name of a non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | 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"). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. QNAM should not be the name of any standard ADaM variable. | SUPPQUAL | |||||||
| QORIG | Origin | An indication of how the value of the non-standard variable originated in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | Because QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. | SUPPQUAL | |||||||
| QVAL | Data Value | The value of the non-standard variable in a dataset (a Supplemental Qualifier dataset) used to represent non-standard variables and their association to records in the parent domain. | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL. | SUPPQUAL | |||||||
| RACE | Race | An arbitrary classification of a taxonomic group that is a division of the human species. | Race of the subject. Sponsors should refer to FDA guidance regarding the collection of race data. | DM | |||||||
| RACEOTH | Speicify Other Race | An operational field for collecting race when none of the pre-specified values for race are applicable. | A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values. | DM | |||||||
| RDEVID | Related Device Identifier | A sequence of characters used to uniquely identify the device that is related to the identified single associated person, group of associated persons, or pool of associated person | Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device. | APRELSUB, Associated Persons | |||||||
| RDOMAIN | Related Domain Abbreviation | An operational variable that holds the domain abbreviation for the domain in which related records are located. | Domain abbreviation of the parent record(s). Null for records collected on general comments or additional information section of CRF. 2-character abbreviation for the domain of the parent record(s). 2-character abbreviation for the domain of the parent record(s). | CO | RELREC, SUPPQUAL | ||||||
| --RECID | Invariant Record Identifier | A sequence of characters used to uniquely identify a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. | Identifier for a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain. | All Classes-General | |||||||
| --REF | Comment Reference | A sponsor-defined description of the source of a particular comment. | Sponsor-defined reference associated with the comment. | CO | |||||||
| RELID | Relationship Identifier | A sequence of characters used to uniquely identify related records within a dataset (the Related Records dataset) used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. | RELID value should be unique within the ID variable (e.g., USUBJID, APID, POOLID, SPDEVID) that is the subject of the relationship. All records with this ID variable that have the same RELID are considered related/associated. RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records. | RELREC | |||||||
| RELMIDS | Temporal Relation to Milestone Instance | A textual description of the temporal relationship of the observation to the disease milestone occurrence identified in the Disease Milestone Instance Name. | The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. | All Classes-General | |||||||
| RELTYPE | Relationship Type | The cardinality (one or many) of records in a specified domain in a relationship among domains. | Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. However, values are only necessary when identifying a relationship between datasets. | RELREC | |||||||
| --REPNUM | Repetition Number | An integer that identifies the particular occurrence of a repeating activity within a sequence. | The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point or within a visit). | Findings-General | |||||||
| --RESLOC | Result Location of Finding | Anatomical location where the result was observed. | Location where the result was observed (as opposed to the location specified for examination). This location may have a higher degree of specificity than the location specified for examination. | Findings-General | |||||||
| --RESTYP | Result Type | Classifies the kind of result originally reported for the test with respect to properties such as substance concentration, proportion, mass rate and appearance. | Classifies the kind of result (i.e., property type) originally reported for the test. | Findings-General | |||||||
| RFCENDTC | Date/Time of Last Challenge Agent Admin | The end date or date and time of the last exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. | The end date or date and time of the last exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. Equal to the latest value of AGENDTC for the challenge agent. | DM | |||||||
| RFCSTDTC | Date/Time of First Challenge Agent Admin | The start date or date and time of the first exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format | The start date or date and time of the first exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. Equal to the earliest value of AGSTDTC for the challenge agent. | DM | |||||||
| --RL | Inclusion/Exclusion Criterion Rule | Rule that expresses the criterion in computer-executable form. | Rule that expresses the criterion in computer-executable form. | TI | |||||||
| RPATH | Description of Planned Repro Path | A planned sequence of reproductive stages within each reproductive phase. | Name of the planned repro path. | TP | |||||||
| RPATHCD | Planned Repro Path Code | C170503 | A short sequence of characters that represents the planned sequence of reproductive stages within each reproductive phase. | DM: Limited to 20 characters. TP: Limited to 20 characters. Should be populated in Demographics when repro paths have been defined in this domain. | DM | TP | |||||
| RPHASE | Repro Phase | A time period in a study that is named for the developmental and reproductive cycle of the study subjects. | SJ: Reproductive phase with which the reproductive stage of the reproductive path is associated. TP: Name of the reproductive phase with which this repro stage of the repro path is associated. | All Classes-General | SJ | TP | |||||
| RPRFDY | Repro Phase Start Reference Day | An integer used to represent the start day of the reproductive phase. | Sponsor protocol-defined first day of repro phase. Should be zero or 1. | TP | |||||||
| --RPT | Disease Milestone Repetition Indicator | An indication as to whether a disease milestone can occur more than once for a subject. | ndicates whether this is a disease milestone that can occur only once ("N") or one that can occur multiple times ("Y"). | TM | |||||||
| --RSDISC | Reason for Treatment Discontinuation | The explanation for why the drug, procedure, or therapy was discontinued. | Reason the treatment was discontinued. | Interventions-General | |||||||
| --RSLSCL | Result Scale | A classification of the scale of the original result value with respect to whether the result is ordinal, nominal, quantitative, or narrative. | Classifies the scale of the original result value with respect to whether the result is, for example, ordinal, nominal, quantitative, or narrative. | Findings-General | |||||||
| RSTAGE | Description of Repro Stage | A descriptive name for the planned study activities that occur during a subject reproductive phase. | SJ: The name of the Repro Stage. If RSTGCD has a value of "UNPLAN" then RSTAGE should be null. TP: The name of the repro stage. TT: The name of the repro stage. | SJ | TP, TT | ||||||
| RSTGCD | Repro Stage Code | A short sequence of characters that represents a descriptive name for the planned study activities that occur during a subject reproductive phase. | SJ: Short name of the Repro Stage used for programming and sorting. Maximum 8 characters. TP: Short name of the repro stage used for programming and sorting. Maximum 8 characters. The values of RSTGCD used in the Trial Paths dataset must match values for the same repro stage in the Trial Stages dataset. TT: Short name of the repro stage, used for programming and sorting. Maximum 8 characters. | SJ | TP, TT | ||||||
| --RSTIND | Restraint Indicator | An indication that the subject was restrained during the course of the activity or assessment. | Findings: An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null. Interventions: An indicator as to whether the animal subject was restrained during the intervention period. Expected values are "Y" or null. | Findings-General Interventions-General | |||||||
| --RSTMOD | Restraint Mode | A description of whether the restraint was physical and/or chemical. | A description of whether the restraint was physical and/or chemical | Findings-General Interventions-General | |||||||
| RSUBJID | Related Subject or Pool Identifier | A sequence of characters used to uniquely identify the study subject or pool of subjects that is related to the identified single associated person, group of associated persons, or pool of associated persons. Or a sequence of characters used to uniquely identify the study subject or pool of subjects that is related to another study subject or pool of study subjects. | RELSUB: Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. APRELSUB: Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects. | RELSUB | APRELSUB, Associated Persons | ||||||
| --MSCBCE | Molecule Secreted by Cells | The textual description of the molecule secreted by the specified cells. | The textual description of the entity secreted by the cells represented in --TEST. The combination of --TEST and --MSBCE should describe the thing, the entity, or the analyte being measured, without the need for additional variables | Findings-General | |||||||
| SET | Set Description | A descriptive name of a group of subjects with shared experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. | Short name of a specific trial set, as defined by the sponsor. Maximum 8 characters. This represents the trial set for which parameters are being submitted. | TS | |||||||
| SEX | Sex | The assemblage of properties or qualities by which male is distinguished from female. | Sex of the subject. | DM | |||||||
| SREL | Subject Relationship | A description of the relationship between a single associated person, a group of associated persons, or a pool of associated persons and a study subject, a pool of study subjects, a device, or the study as a whole. | RELSUB: Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID. APRELSUB: If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID. | RELSUB | APRELSUB, Associated Persons | ||||||
| --STAT | Completion Status | An indication that no result to a test (or set of tests) is present, or that a question about the occurrence of a prespecified event or intervention has no response. | Used to indicate when a question about the occurrence of a prespecified event was not answered. Should be null or have a value of "NOT DONE". Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE". Used to indicate when a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE". | Events-General Findings-General Interventions-General | |||||||
| --STGORD | Order of Repro Stage within Repro Path | An assigned numeric identifier that gives the planned order of the reproductive stage within the reproductive path of the study. | Number that gives the planned order of the repro stage within the repro path. | TP | |||||||
| --STOFF | Offset from the Anchor | The interval of time from the anchor value to the first assessment in the planned assessment schedule, represented in a standardized character format. | A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be a non-negative duration. | TD | |||||||
| --STREFC | Reference Result in Standard Format | The standardized reference value for the standardized result of the measurement, test, or examination in character format. | Reference value for the result or finding copied or derived from --ORREF in a standard format. | Findings-General | |||||||
| --STREFN | Numeric Reference Result in Std Units | The standardized reference value for the standardized result of the measurement, test, or examination in numeric format. | Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable. | Findings-General | |||||||
| --STRL | TE: Rule for Start of Element TT: Rule for Start of Repro Stage TV: Visit Start Rule | Identifies the condition or criterion that defines the beginning of a planned period of time within the study. | TE:Expresses the rule for beginning the element. TT: Expresses the rule for beginning the repro stage. TV: Rule describing when the visit starts, in relation to the sequence of elements. | TE, TT, TV | |||||||
| --TDOSD | Toxic/Physiologic Dose Descr | A description of a statistically derived estimate of a dose with a certain toxicological or physiological effect in a population, based on data from a dose-response study. | A description of a statistically derived estimate of a dose with a certain toxicological or physiological effect in a population, based on data from a dose-response study. | Interventions-General | |||||||
| --TGTPAI | Planned Assessment Interval | The planned interval between disease assessments n the planned assessment schedule, represented in a standardized character format. | The planned interval between disease assessments. | TD | |||||||
| --TRANS | Transition Rule | A decision point condition which allows a subject to move to an element other than the next element in the planned sequence within the arm. | If the trial design allows a subject to transition to an element other than the next element in sequence, then the conditions for transitioning to those other elements, and the alternative Element sequences, are specified in this rule. | TA | |||||||
| --TSTCND | Test Condition | Describes any planned condition imposed on the test system at the time the test is performed. | Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed. | Findings-General | |||||||
| --TSTDTL | Measurement, Test, or Examination Detail | A description of a targeted facet of a test or assessment. | Further description of --TESTCD and --TEST. | Findings-General | |||||||
| --TSTOPO | Test Operational Objective | The textual description of the operational purpose of the test. | The textual description of the high-level purpose of the test at the operational level. | Findings-General | |||||||
| --UPDES | SE: Description of Unplanned Element SV: Description of Unplanned Visit SJ: Description of Unplanned Repro Stage | A description of an element, visit, or subject reproductive stage that differs from those that are in the protocol plan. | SE: Description of what happened to the subject during an unplanned element. Used only if ETCD has the value of "UNPLAN". SV: Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits. SJ; Description of what happened to the subject during an unplanned Repro Stage. Used only if RSTGCD has the value of "UNPLAN". | SE, SV, SJ | |||||||
| --VAL | CO: Comment AC: Parameter Value TS: Parameter Value TT: Trial Set Parameter Value DI: Device Identifier Element Value OI: Non-Host Organism ID Element Value | The result or response for the parameter, or text of a comment. | CO: The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. AC: Value of ACPARM. TS: Value of TSPARM. If TSVAL is null, a value is required for TSVALNF. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. TX: Value of the trial set parameter. Some parameters may be subject to controlled terminology. DI: Value for the parameter. OI: Value for the taxon in OIPARMCD/OIPARM for the organism identified by NHOID. | CO | AC, TS, TX | DI, OI | |||||
| --VALCD | Parameter Value Code | A standardized or dictionary-derived short sequence of characters used to represent the result or response for the parameter. | TS: Code of the term in TSVAL from the reference terminology cited in TSVCDREF AC: This is the code of the term in ACVAL. | TS, AC | |||||||
| --VALNF | Parameter Null Flavor | A standardized or dictionary-derived short sequence of characters describing the reason why the parameter value (--VAL) is not populated. | TS: Null flavor for the value of TSVAL describing the reason the value is null, to be populated only if TSVAL is null. AC: Null flavor for the value of ACPARM, to be populated if and only if ACVAL is null. | TS, AC | |||||||
| --VALU | Parameter Units | The unit of measure for the result for the parameter. | Units for the value in ACVAL, if applicable. | AC | |||||||
| --VCDREF | Name of the Reference Terminology | The name of the reference terminology from which the parameter value (–VAL) and parameter value code (–VALCD) are taken or the name of the format standard used to represent the parameter value (--VAL). | TS: he name of the reference terminology or standard format from which TSVALCD is taken. AC: The name of the reference terminology from which ACVALCD is taken. | TS, AC | |||||||
| --VCDVER | Version of the Reference Terminology | The version of the reference terminology from which the parameter value (–VAL) and parameter value code (–VALCD) are taken. | TS: The version number of the reference terminology cited in TSVCDREF, if applicable. AC: The version number of the reference terminology cited in ACVCDREF, if applicable. | TS, AC | |||||||
| --VERS | Protocol Criteria Versions | The protocol version identifier of the Inclusion/Exclusion criteria. | The number of this version of the inclusion/exclusion criteria. May be omitted if there is only 1 version. | TI | |||||||
| --XDY | Day of Obs Relative to Exposure | The number of days from the first date of protocol-specified treatment exposure to the date of collection (--DTC), used in study data tabulation. | The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General | |||||||
| --XENDY | End Day of Obs Relative to Exposure | The number of days from the first date of protocol-specified treatment exposure to the end of an intervention or event (--ENDTC), used for study data tabulation. | The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General | |||||||
| --XSTDY | Start Day of Obs Relative to Exposure | The number of days from the first date of protocol-specified treatment exposure to the start of an intervention or event (--STDTC), used for study data tabulation. | The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | All Classes-General |
Table 2. Variable Definitions included in Batch 1, extended to additional domains in Batch 2
Note that
| Root Variable Name | Variable Label | Variable C-code | Definition | Notes | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| --CAT1 | Category TI: Inclusion/Exclusion Category | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | TI: Used for categorization of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | Findings-General Interventions-General Events-General | TI | |||||
| --EVAL | Evaluator | C51824 | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Used only for results that are subjective (e.g., assigned by a person or a group). Used to describe the originator of the comment. | Findings-General | CO | |||||
| --EVALID | Evaluator Identifier | C117043 | A sequence of characters used to uniquely identify the evaluator(s). | Used to distinguish multiple evaluators with the same role recorded in --EVAL. | Findings-General | CO | |||||
| --REFID | Reference ID | C82531 | A sequence of characters used to uniquely identify a source of information. | All Classes-General | RELSPEC | ||||||
| --SCAT1 | Subcategory TI: Inclusion/Exclusion Subcategory | C25692 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. TI: A further categorization of the exception criterion. Can be used to distinguish criteria for a substudy or to categorize major or minor exceptions. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | Findings-General Interventions-General Events-General | TI | |||||
| SPDEVID | Sponsor Device Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | DI: Sponsor-defined identifier for the device. DR: Sponsor-defined identifier for the device. It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers) as defined in DI. | All Classes-General | DI | DR | ||||
| --SPEC2 | Specimen Material Type RELSPEC: Specimen Type | C70713 | The type of sample material taken from a biological entity. | Findings-General | RELSPEC | ||||||
| TAETORD3 | Planned Order of Element Within Arm | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | All Classes-General | TA | ||||||
| --TEST1 | Name of Measurement, Test, or Exam TI: Inclusion/Exclusion Criterion | C82503 | The standardized or dictionary-derived name of the measurement, test, or examination. | TI: Full text of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | Findings-General | TI | |||||
| --TESTCD1 | Short Name of Measurement, Test, or Exam TI: Inclusion/Exclusion Criterion Short Name | C82503 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | Used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. TI: Short name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain. | Findings-General | TI |
- The TI domain includes variables IETESTCD, IETEST, IECAT, and IESCAT. Although "IE" is not the domain code for the TI domain, these variables are considered instantiations of the root variables --TESTCD, --TEST, --CAT, and --SCAT.
- The variable SPEC in the RELSPEC domain is not named with a two-variable domain code prefix, but is considered to be an instantiation of the root variable --SPEC.
- The variable TAETORD is a timing variable in the general observation classes. In the TA domain, the first two characters of the variable TAETORD are the domain code. However, TAETORD is considered to be an instantiation of the root variable TAETORD, rather than a root variable --ETORD.
Table 3. Changes to Batch 1 root variable definitions
| Variable Name | Variable Label | Variable C-Code | Definition | Notes | CDASH | Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ARM | Description of Planned Arm | C170984 | The name of the planned arm to which the subject was assigned. The name of a planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path. | DM | TA, TV | ||||||
| --DUR | Collected Duration | C170992 |
The collected length of time during which an observation continues or the planned duration of the element, represented in a standardized character format. | Used only if collected on the CRF and not derived. TE: Used when the rule for ending the element is applied after a fixed duration. TT: Used when the rule for ending the repro stage is applied after a fixed duration. | All Classes-General | TE, TT | |||||
| --DY1 | Study Day of Visit/Collection/Exam |
C170993 |
The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. DM: The actual study day of demographic data collection derived relative to the sponsor-defined reference start date. CO: Actual study day of the comment, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | All Classes-General | DM, CO | |||||
| --ENDY | Study Day of End of Observation | C170995 |
The number of days from the sponsor-defined reference start date to the end of an intervention, event, finding, element, or subject reproductive phase (--ENDTC), used for study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. SE: Study day of end of element relative to the sponsor-defined RFSTDTC. SV: Study day of end of visit relative to the sponsor-defined RFSTDTC. SM: Study day of start of disease milestone instance, relative to the sponsor-defined RFSTDTC. | All Classes-General | SE, SV, SM | |||||
| --METHOD2 | Interventions: Method of Administration Findings: Method of Test or Examination |
|
A process or systematic course of actions for performing a measurement, examination or test, or the method of intervention administration in the non-clinical context. | Interventions: Method of administration of the treatment. Findings: Method of the test or examination. | Interventions-General; Findings-General | ||||||
| --SEQ | Sequence Number | C70710 |
A number used in combination with other domain variables to uniquely identify records within the domain. | May be any valid number (including decimals) and does not have to start at 1. Datasets that do not contain subject data, such as the Trial Summary (TS) domain and the Device Tracking (DT) domains, use --SEQ as a sequence number to ensure uniqueness within the dataset. CO: Sequence number to ensure uniqueness within the dataset. SE: Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order. SJ: Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order. SM: Sequence number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order. AC: Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same ACPARMCD. TS: Sequence number to ensure uniqueness within the dataset. TX: Unique number for this record within this dataset. DI: Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID). OI: Sequence number given to ensure uniqueness within a parameter within an organism (NHOID). | All Classes-General | CO, SE, SJ, SM | AC, TS, TX | DI, OI | |||
| --SETCD | Set Code | C117457 |
The short sequence of characters used to represent the trial set. | DM: Defined by the sponsor. Maximum of 8 characters. This represents the code for the trial set for which parameters are being submitted. TX: Short name of a specific trial set, as defined by the sponsor. Maximum 8 characters. This represents the trial set for which parameters are being submitted. | DM | TX | |||||
| --TRT | Name of Treatment | C82542 |
The reported name of the substance, treatment, or procedure administered to or used by the subject. | The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation. | Interventions-General | ||||||
| --LOT | Lot Number | C70848 |
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. | Lot number for the intervention described in --TRT. | Interventions-General | ||||||
| --USCHFL | Unscheduled Flag | C170510 |
An indication that the performed test or observation was done at a time that was not planned. | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used. | Interventions-General; Events-General; Findings-General | ||||||
| --BLFL | Baseline Flag | C82526 |
An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation. | Indicator used to identify a baseline value. Should be "Y" or null. | Findings-General | ||||||
| --GRPID | Group ID | C170996 | A sequence of characters used to identify a group of related records. In domains that represent study subject data, the records are grouped within a subject. | Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in See also Section 4.1.6, Trial Summary Information and Section 4.1.7, Challenge Agent Characterization. | All Classes-General | ||||||
| --LNKID | Link ID | C117050 |
A sequence of characters used to uniquely identify a record, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. | This may be a one-to-one or a one-to-many relationship. | All Classes-General | |||||
| --LNKGRP | Link Group ID | C117049 |
A sequence of characters used to uniquely identify a group of records, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | This will usually be a many-to-one relationship. | All Classes-General | |||||
| --DTC1 | Date/Time of Collection DM: Date/Time of Comment CO: Date/Time of Collection |
C82515 |
The date or date and time of the assessment or the specimen or data collection, represented in a standardized character format. | Collection date and time of an observation. CO: Date or date and time of comment on dedicated comment form, if collected. Should be null if this is a child record of another domain or if comment date was not collected. DM: The date or date and time of demographic data collection, represented in a standardized character format. | All Classes-General | DM, CO | |||||
| --STDTC | Start Date/Time of Observation | C82517 |
The start date or date and time of an intervention, event, element, or subject reproductive phase, represented in a standardized character format. | Start date/time of an observation. | The start date of a Findings class record is stored in the --DTC variable. | All Classes-General | |||||
| --ENDTC | End Date/Time of Observation SE: End Date/Time of Element SV: End Date/Time of Visit SM: End Date/Time of Milestone SJ: End Date/Time of Repro Stage | C82516 |
The end date or date and time of an intervention, event, finding, element, or subject reproductive phase, represented in a standardized character format. | End date/time of the observation. SE: End date/time of an element for each subject. SV: End date/time of a subject's visit. SM: End date/time of disease milestone Instance. SJ: End date/time for a Repro Stage for each subject. | All Classes-General | SE, SV, SM, SJ | |||||
| --STDY | Study Day of Start of Observation SE: Study Day of Start of Element SV: Study Day of Start of Visit | Study Day of Start of Observation |
The number of days from the sponsor-defined reference start date to the start of an intervention, event, element, visit, milestone or subject reproductive phase (--STDTC), used for study data tabulation. | Actual study day of start of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. SE: Study day of start of element relative to the sponsor-defined RFSTDTC. SV: Study day of start of visit relative to the sponsor-defined RFSTDTC. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General | SE, SV. | ||||
| --ENDY | Study Day of End of Observation SE: Study Day of End of Element SV: Study Day of End of Visit | Study Day of End of Observation |
The number of days from the sponsor-defined reference start date to the end of an intervention, event, finding, element, or subject reproductive phase (--ENDTC), used for study data tabulation. | Actual study day of end of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. SE: Study day of end of element relative to the sponsor-defined RFSTDTC. SV: Study day of end of visit relative to the sponsor-defined RFSTDTC. | The sponsor-defined reference start date is RFSTDTC in Demographics. | All Classes-General | SE, SV |
- In Batch 1, DMDTC and DMDY were defined separately. The Demographics-specific definitions are being removed in Batch 2. DMDY and DMDTC are considered instantiations of the root variables --DY and --DTC.
- In Batch 1, EXMETHOD was defined separately. The Exposure-specific definition is being removed in Batch 2. EXMETHOD is considered an instantiation of the root variable --METHOD.