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Information for Reviewers

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Table 3. Changes to existing Batch 1 root variables.

RoleVariable NameVariable LabelTypeVariable Name (no prefix)DefinitionErin comment to team - remove column before PRObservation ClassImplementation Notes
Record Qualifier--LOTLot NumberCharLOT

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.


Interventions-GeneralLot number for the intervention described in --TRT.
Record Qualifier--USCHFLUnscheduled FlagCharUSCHFL

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.


Interventions-General; Events-General; Findings-GeneralIndicates 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--BLFLBaseline FlagCharBLFL

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.


Findings-GeneralIndicator used to identify a baseline value. Should be "Y" or null.
Identifier--GRPIDGroup IDCharGRPIDA sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary dataset, or parameters in the Challenge Agent Characterization dataset.

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-GeneralOptional 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--LNKIDLink IDCharLNKID

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.


All Classes-GeneralIdentifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
Identifier--LNKGRPLink Group IDCharLNKGRP

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.


All Classes-GeneralIdentifier used to link related records across domains. This will usually be a many-to-one relationship.
Timing--DTCDate/Time of CollectionCharDTC

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.


All Classes-GeneralCollection date and time of an observation.
Timing--STDTCStart Date/Time of ObservationCharSTDTC

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.


All Classes-GeneralStart date/time of an observation.
Timing--ENDTCEnd Date/Time of ObservationCharENDTC

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.


All Classes-GeneralEnd date/time of the observation.
Timing--STDYStudy Day of Start of ObservationNumSTDY

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.


All Classes-GeneralActual study day of start of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics.
Timing--ENDYStudy Day of End of ObservationNumENDY

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.


All Classes-GeneralActual study day of end of observation expressed in integer days relative to The sponsor-defined reference start date is RFSTDTC in Demographics.
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