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| Root Variable Name | Definition | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|
| --CAT1 | A grouping or classification of the topic of the finding, event, or intervention. | Findings-General Interventions-General Events-General | TI | |||||
| --EVAL | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Findings-General | CO | |||||
| --EVALID | A sequence of characters used to uniquely identify the evaluator(s). | Findings-General | CO | |||||
| --REFID | A sequence of characters used to uniquely identify a source of information. | All Classes-General | RELSPEC | |||||
| --SCAT1 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | Findings-General Interventions-General Events-General | TI | |||||
| SPDEVID | A sequence of characters used by the sponsor to uniquely identify a specific device. | All Classes-General | DI | DR | ||||
| --SPEC2 | The type of sample material taken from a biological entity. | Findings-General | RELSPEC | |||||
| TAETORD3 | ||||||||
| --TEST1 | The standardized or dictionary-derived name of the measurement, test, or examination. | Findings-General | TI | |||||
| --TESTCD1 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | Findings-General | TI |
...
Table 3. Changes to existing Batch 1 root variables.
| Role | Variable Name | Variable Label | Type | Variable Name (no prefix) | Definition |
|---|
| CDASH | Observation Class |
|---|
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.
| Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons | Implementation Notes | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ARM | 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 |
The collected length of time during which an observation continues or the planned duration of the element, represented in a standardized character format. | All Classes-General | TE, TT | ||||||||||
| --DY1 |
The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | All Classes-General | DM, CO | ||||||||||
| --ENDY |
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. | All Classes-General | SE, SV, SM | ||||||||||
| --METHOD2 |
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-General; Findings-General | |||||||||||
| --SEQ |
A number used in combination with other domain variables to uniquely identify records within the domain. | All Classes-General | CO, SE, SJ, SM | AC, TS, TX | DI, OI | ||||||||
| --SETCD |
The short sequence of characters used to represent the trial set. | DM | |||||||||||
| --TRT |
The reported name of the substance, treatment, or procedure administered to or used by the subject. | Findings-General | |||||||||||
| Record Qualifier | --LOT | Lot Number | Char | LOT |
An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. | Interventions-General | Lot number for the intervention described in --TRT. | ||||||
| Record Qualifier | --USCHFL | Unscheduled Flag | Char | USCHFL |
An indication that the performed test or observation was done at a time that was not planned. | Interventions-General; Events-General; |
| Findings-General | 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. | ||||||||||||
| Record Qualifier | --BLFL | Baseline Flag | Char | BLFL |
An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation. | Findings-General | Indicator used to identify a baseline value. Should be "Y" or null. | ||||||
| Identifier | --GRPID | Group ID | Char | GRPID | 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. | All Classes-General | 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. | ||||||
| Identifier | --LNKID | Link ID | Char | LNKID |
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. | All Classes-General | Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. | ||||||
| Identifier | --LNKGRP | Link Group ID | Char | LNKGRP |
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. | All Classes-General | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | ||||||
| Timing | --DTC1 | Date/Time of Collection | Char | DTC |
The date or date and time of the assessment or the specimen or data collection, represented in a standardized character format. | All Classes-General | DM, CO | Collection date and time of an observation. | |||||
| Timing | --STDTC | Start Date/Time of Observation | Char | STDTC |
The start date or date and time of an intervention, event, element, or subject reproductive phase, represented in a standardized character format. | All Classes-General | Start date/time of an observation. | ||||||
| Timing | --ENDTC | End Date/Time of Observation | Char | ENDTC |
The end date or date and time of an intervention, event, finding, element, or subject reproductive phase, represented in a standardized character format. | All Classes-General | SE, SV, SM, SJ | End date/time of the observation. | |||||
| Timing | --STDY | Study Day of Start of Observation | Num | STDY |
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. | All Classes-General | Actual study day of start of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics. | ||||||
| Timing | --ENDY | Study Day of End of Observation | Num | ENDY |
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. |
| All Classes-General | Actual study day of end of observation expressed in integer days relative to The |
| sponsor-defined reference start date |
| is RFSTDTC in Demographics. |
- 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.