...
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. Associated 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 substance in a binding relationship with the entity in the test name (--TEST), where the combination of that substance and the entity in the test name describe the analyte being measured. | 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. | showSummary | false
|
JIRA) columnIds issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key
SDSVAR-
173
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.
Interventions-General
Events-General
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.
TE: Rule for End of Element
TT: Rule for End of Repro Stage
TV: Visit End Rule
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.
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.
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: 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).
Findings-General
Interventions-General
Findings: Location Used for the Measurement
Interventions: Location of Administration
Events: Location of Event
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.
Interventions-General
Events-General
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.
The lower limit of the allowed range for the planned interval between disease assessments.
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.
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: 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
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 Set 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.
Findings-General
Interventions-General
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.
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.
Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.
Related Domain Abbreviation
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).
Comment Reference
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).
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.
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.
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.
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: 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.
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.
Interventions-General
Interventions-General
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.
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
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.
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".
Findings-General
Interventions-General
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.
TE: Rule for Start of Element
TT: Rule for Start of Repro Stage
TV: Visit Start Rule
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.
SE: Description of Unplanned Element
SV: Description of Unplanned Visit
SJ: Description of Unplanned Repro Stage
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".
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
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.
Parameter Value Code
TS: Code of the term in TSVAL from the reference terminology cited in TSVCDREF
AC: This is the code of the term in ACVAL.
Parameter Null Flavor
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: 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.
Version of the Reference Terminology
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.
Protocol Criteria Versions
...
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 | ||||||||||||||||||||||||
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 | |||||||||||||||||||||||
--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 | ., 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.
| --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 |
...
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 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
| showSummary | false
|
SDSVAR-
174
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.
The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation.
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.
Interventions: Method of Administration
Findings: Method of Test or Examination
C119826[EXMETHOD]
Method of administration of the treatment. [EXMETHOD]
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.
A number used to uniquely identify records for a subject within a domain.
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).
The standardized or dictionary-derived short sequence of characters used to represent the trial set.
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.
The reported name of the drug, procedure, or therapy.
The reported name of the substance, treatment, or procedure administered to or used by the subject.
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product.
An indication that the performed test or observation was done at a time that was not preplanned.
An indication that the performed test or observation was done at a time that was not planned.
An indication that the record is the baseline assessment, used in study data tabulation.
An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation.
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.
A sequence of characters used to uniquely identify a record in one domain and link it to 1 or more records in another domain.
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.
A sequence of characters used to uniquely identify a group of records in one domain and link it to 1 or more records in another domain.
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.
This will usually be a many-to-one relationship.
Date/Time of Collection
DM: Date/Time of Comment
CO: Date/Time of Collection
C83243[DMDTC]
C82515
The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format.
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.
The start date or date and time of an intervention, event, or element, represented in a standardized character format.
The start date or date and time of an intervention, event, element, or subject reproductive phase, represented in a standardized character format.
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
The start date or date and time of an intervention, event, or element, represented in a standardized character format.
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.
Study Day of Start of Observation
SE: Study Day of Start of Element
SV: Study Day of Start of Visit
The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation.
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.
Study Day of End of Observation
SE: Study Day of End of Element
SV: Study Day of End of Visit
The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation.
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.
...