Information for Reviewers
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Table 1. <<insert name/description>>
Table 2. <<insert name/description>>
Table 3. Changes to existing Batch 1 root variables.
| Role | Variable Name | Variable Label | Type | Variable Name (no prefix) | Definition | Observation Class | Implementation Notes |
|---|---|---|---|---|---|---|---|
| Record Qualifier | --LOT | Lot Number | Char | LOT | An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch. | 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 | 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 | --USCHFL | Unscheduled Flag | Char | USCHFL | An indication that the performed test or observation was done at a time that was not planned. | Events-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. |
| Record Qualifier | --USCHFL | Unscheduled Flag | Char | USCHFL | An indication that the performed test or observation was done at a time that was not planned. | 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. |
| Identifier | --GRPID | Group ID | Char | GRPID | A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary dataset. 16June2020 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 | --DTC | Date/Time of Collection | Char | DTC | The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format. | All Classes-General | 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 | 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. |
| Identifier | RDOMAIN | Related Domain Abbreviation | Char | RDOMAIN | An abbreviation for a collection of observations, with a topic-specific commonality. | Relationship | 2-character abbreviation for the domain of the parent record(s). |