| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|
| Study Identifier | Char |
| Req | LB.STUDYID |
| USUBJID | Unique Subject Identifier | Char |
| Req | LB.USUBJID |
| TRTP | Planned Treatment | Char |
| Cond | ADSL.TRT01P |
| TRT01P | Planned Treatment for Period xx | Char |
| Cond | ADSL.TRT01P |
| TRTA | Actual Treatment | Char |
| Cond | ADSL.TRT01A |
| TRT01A | Actual Treatment for Period xx | Char |
| Cond | ADSL.TRT01A |
| ADT | Analysis Date | Num |
| Perm | LB.LBDTC captured as a date in numeric format. |
| ADTM | Analysis Datetime | Num
|
| Perm | LB.LBDTC captured as a datetime in numeric format. |
| ADY | Analysis Relative Day | Num |
| Perm | LB.LBDY |
| AVISIT | Analysis Visit | Char |
| Cond | LB.VISIT |
| AVISITN | Analysis Visit (N) | Num |
| Perm | LB.VISITNUM |
| PARAM | Parameter | Char |
| Req | LB.LBTEST concatenated with LB.LBSTRESU |
| PARAMCD | Parameter Code | text |
| Req | The short name of the analysis parameter in PARAM. The values of PARAMCD must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). These constraints will allow for a BDS dataset to be transposed in such a way that the values of PARAMCD can be used as valid ADaM variable names per ADaMIG v1.2 Section 3.1.1, General Variable Conventions. There must be a one-to-one relationship between PARAM and PARAMCD within a dataset.
PARAMCD must be present and populated on every record in a BDS dataset. | LB.LBTESTCD |
| PARAMN | Parameter (N) | Num |
| Perm | Numeric representation of PARAM. Useful for ordering and programmatic manipulation. There must be a one-to-one relationship between PARAM and PARAMN within a dataset for all parameters where PARAMN is populated.
if PARAMN is populated on any record for a PARAM, it must be populated on every record for that PARAM. |
|
| PARCATy | Parameter Category y | Char |
| Perm | A categorization of PARAM within a dataset. For example, values of PARCAT1 might group the parameters having to do with a particular questionnaire, lab specimen type, or area of investigation. Note that PARCATy is not a qualifier for PARAM. PARAM to PARCATy is a many-to-one mapping; any given PARAM may be associated with at most one level of PARCATy (e.g., one level of PARCAT1 and one level of PARCAT2).LB.LBCAT |
| AVAL | Analysis Value | Num |
| Cond | Numeric analysis value described by PARAM. On a given record, it is permissible for AVAL, AVALC, or both to be null. AVAL is required if AVALC is not present, since either AVAL or AVALC must be present in the dataset.LB.LBSTRESN |
| BASE | Baseline Value | Num |
| Cond | The subject's baseline analysis value for a parameter and baseline definition (i.e., BASETYPE) if present. BASE contains the value of AVAL copied from a record within the parameter on which ABLFL = "Y". Required if dataset supports analysis or review of numeric baseline value or functions of numeric baseline value. 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. Note that a baseline record may be derived (e.g., it may be an average) in which case DTYPE must be populated on the baseline record.AVAL where ABLFL=Y |
| CHG | Change from Baseline | Num |
| Perm | Change from baseline analysis value. Equal to AVAL-BASE. If used for a given PARAM, should be populated for all post-baseline records of that PARAM regardless of whether that record is used for analysis. The decision on how to populate pre-baseline and baseline values of CHG is left to producer choice. |
| ABLFL | Baseline Record Flag | Char | Y | Cond | Character indicator to identify the baseline record for each subject, parameter, and baseline type (BASETYPE) combination. See BASETYPE in ADaMIG v1.2 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. | ANLzzFL | Analysis Flag zz | Char | Y | Cond | ANLzzFL is a conditionally required flag to be used in addition to other selection variables when the other selection variables in combination are insufficient to identify the exact set of records used for one or more analyses. Often one ANLzzFL will serve to support the accurate selection of records for more than one analysis. Note that it is allowable to add additional descriptive text to the label (see ADaMIG v1.2 Section 3.1.6, Item 1).
When defining the set of records used in a particular analysis or family of analyses, ANLzzFL is supplemental to, and is intended to be used in conjunction with, other selection variables, such as subject-level, parameter-level and record-level population flags, AVISIT, DTYPE, grouping variables such as SITEGRy, and others. The lower-case letter "zz" in the variable name is an index for the zzth 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.set to Y for last pre-treatment assessment fir each parameter |
| COUNTRY | Country | Char |
| Perm | ADSL.COUNTRY |
| AGE | Age | Num |
| Perm | ADSL.AGE |
| SEX | Sex | Char |
| Perm | ADSL.SEX |
| RACE | Race | Char |
| Perm | ADSL.RACE |
| ETHNIC | Ethnicity | Char |
| Perm | ADSL.ETHNIC |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL |
| TRTSDT | Date of First Exposure to Treatment | Num |
| Perm | ADSL.TRTSDT |
| TRTSDTM | Datetime of First Exposure to Treatment | Num |
| Perm | ADSL.TRTSDTM |
| TRTEDT | Date of Last Exposure to Treatment | Num |
| Perm | ADSL.TRTEDT |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer |
| Perm | ADSL.TRTEDTM |
| LBSEQ | Sequence Number | Num |
| Perm | LB.LBSEQ |
| VISIT | Visit Name | Char |
| Perm | LB.VISIT |
| VISITNUM | Visit Number | Num |
| Perm | LB.VISITNUM |