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| 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 | TS, AC | |||||
| --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 | SE, SV, SM, SJ | ||||
| --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 |
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