8) Indicator Variables for BDS Datasets

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

ABLFL

Baseline Record Flag

Char

Y

Cond

Character indicator to identify the baseline record for each subject, parameter, and baseline type (BASETYPE) combination. ADD LINK See BASETYPE in Table 3.3.4.1.1. ABLFL is required if BASE is present in the dataset.

A baseline record may be derived (e.g., it may be an average), in which case DTYPE must also be populated. If BASE is populated for a parameter, and BASE is non-null for a subject for that parameter, then there must be a record flagged by ABLFL for that subject and parameter.

ABLFN

Baseline Record Flag (N)

Num

1

Perm

Numeric representation of ABLFL. There must be a one-to-one relationship between ABLFN and ABLFL.

ABLFN cannot be present unless ABLFL is also present. When ABLFL and ABLFN are present, then on a given record, either both must be populated or both must be null.

ANLzzFL

Analysis Flag zz

Char

Y

Cond

as SITEGRy, and others. The lower-case letter "zz" in the variable name is an index for the zz^th record selection algorithm where "zz" is replaced with a zero-padded two-digit integer [01-99]. Every record selection algorithm "zz" (i.e., every algorithm for populating an ANLzzFL) must be defined in variable metadata. When the set of records that the algorithm "zz" operates on is pre-filtered by application of other criteria, such as a record-level population flag, then the selection algorithm definition in the metadata must so specify.

Note that the ANLzzFL value of Y indicates that the record fulfilled the requirements of the algorithm, but does not necessarily imply that the record was actually used in one or more analyses, as whether or not a record is used also depends on the other selection variables applied. The ANLzzFL flag is useful in many circumstances; an example is when there is more than one record for an analysis timepoint within a subject and parameter, as it can be used to identify the record chosen to represent the timepoint for an analysis. "zz" is an index for a record selection algorithm, such as "record closest to target relative day for the AVISIT, with ties broken by the latest record, for each AVISIT within <list of AVISITS>."

Note that it is not required that a specific ANLzzFL variable has the same definition across a project or even across datasets within a study. There is also no requirement that the ANLzzFL variables in a dataset or study be used in numerical order; e.g. ANL02FL might occur in a dataset or study without ANL01FL present in the same dataset or study.

ANLzzFN

Analysis Flag zz (N)

Num

1

Perm

Numeric representation of ANLzzFL. There must be a one-to-one relationship between ANLzzFN and ANLzzFL within a dataset.

ANLzzFN cannot be present unless ANLzzFL is also present. When ANLzzFL and ANLzzFN are present, then on a given record, either both must be populated or both must be null.

ONTRTFL

On Treatment Record Flag

Char

Y

Perm

Character indicator of whether the observation occurred while the subject was on treatment. ONTRTFL is producer-defined, and its definition may vary across datasets in a study based on analysis needs.

ONTRTFN

On Treatment Record Flag (N)

Num

1

Perm

Numeric representation of ONTRTFL. There must be a one-to-one relationship between ONTRTFN and ONTRTFL within a dataset.

ONTRTFN cannot be present unless ONTRTFL is also present. When ONTRTFL and ONTRTFN are present, then on a given record, either both must be populated or both must be null.

LVOTFL

Last Value On Treatment Record Flag

Char

Y

Perm

Character indicator of the subject's last non-missing value on treatment for each parameter.

LVOTFN

Last Value On Treatment Record Flag (N)

Num

1

Perm

Numeric representation of LVOTFL. There must be a one-to-one relationship between LVOTFN and LVOTFL within a dataset.

LVOTFN cannot be present unless LVOTFL is also present. When LVOTFL and LVOTFN are present, then on a given record, either both must be populated or both must be null.