Timing Variables for BDS Datasets

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

ADT

Analysis Date

Num

Cond

The date associated with AVAL and/or AVALC in numeric format.

ATM

Analysis Time

Num

Cond

The time associated with AVAL and/or AVALC in numeric format.

ADTM

Analysis Datetime

Num

Cond

The datetime associated with AVAL and/or AVALC in numeric format.

ADY

Analysis Relative Day

Num

Cond

The relative day of AVAL and/or AVALC. The number of days from an anchor date (not necessarily DM.RFSTDTC) to ADT. See Timing Variable Conventions. If a dataset contains more than one record per parameter per subject, then an SDTM or ADaM relative timing variable must be present

(ADY would meet this requirement).

ADTF

Analysis Date Imputation Flag

Char

(DATEFL)

Cond

The level of imputation of analysis date. If ADT (or the date part of ADTM) was imputed, ADTF must be populated and is required. See Date and Time Imputation Flag Variables.

ATMF

Analysis Time Imputation Flag

Char

(TIMEFL)

Cond

The level of imputation of analysis time. If ATM (or the time part of ADTM) was imputed, ATMF must be populated and is required. See Date and Time Imputation Flag Variables.

ASTDT

Analysis Start Date

Num

Cond

The start date associated with AVAL and/or AVALC. ASTDT and AENDT may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration.

ASTTM

Analysis Start Time

Num

Cond

The start time associated with AVAL and/or AVALC. ASTTM and AENTM may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration.

ASTDTM

Analysis Start Datetime

Num

Cond

The start datetime associated with AVAL and/or AVALC. ASTDTM and AENDTM may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration.

ASTDY

Analysis Start Relative Day

Num

Cond

The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT. Timing Variable Conventions. If a dataset contains more than one record per parameter per subject then, an SDTM or ADaM relative timing variable must be present (ASTDY would meet this requirement).

ASTDTF

Analysis Start Date Imputation Flag

Char

(DATEFL)

Cond

The level of imputation of analysis start date. If ASTDT (or the date part of ASTDTM) was imputed, ASTDTF must be populated and is required. See Date and Time Imputation Flag Variables.

ASTTMF

Analysis Start Time Imputation Flag

Char

(TIMEFL)

Cond

The level of imputation of analysis start time. If ASTTM (or the time part of ASTDTM) was imputed, ASTTMF must be populated and is required. See Date and Time Imputation Flag Variables.

AENDT

Analysis End Date

Num

Cond

The end date associated with AVAL and/or AVALC. See also ASTDT.

AENTM

Analysis End Time

Num

Cond

The end time associated with AVAL and/or AVALC. See also ASTTM.

AENDTM

Analysis End Datetime

Num

Cond

The end datetime associated with AVAL and/or AVALC. See also ASTDTM.

AENDY

Analysis End Relative Day

Num

Cond

The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT. See Section 3.1.2, Timing Variable Conventions. If a dataset contains more than one record per parameter per subject, then an SDTM or ADaM relative timing variable must be present (AENDY would meet this requirement).

AENDTF

Analysis End Date Imputation Flag

Char

(DATEFL)

Cond

The level of imputation of analysis end date. If AENDT (or the date part of AENDTM) was imputed, AENDTF must be populated and is required. See Date and Time Imputation Flag Variables.

AENTMF

Analysis End Time Imputation Flag

Char

(TIMEFL)

Cond

The level of imputation of analysis end time. If AENTM (or the time part of AENDTM) was imputed, AENTMF must be populated and is required. See Date and Time Imputation Flag Variables.

AVISIT

Analysis Visit

Char

Cond

The analysis visit description; required if an analysis is done by nominal, assigned or analysis visit. AVISIT may contain the visit names as observed (i.e., from SDTM VISIT), derived visit names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these.

AVISIT is a derived field and does not have to map to VISIT from the SDTM. AVISIT represents the analysis visit of the record, but it does not mean that the record was analyzed. There are often multiple records for the same subject and parameter that have the same value of AVISIT. ANLzzFL and other variables may be needed to identify the records selected for any given analysis. See Section 3.3.8, Indicator Variables for BDS Datasets, for information about flag variables. AVISIT should be unique for a given analysis visit window. In the event that a record does not fall within any predefined analysis timepoint window, AVISIT can be populated in any way that the producer chooses to indicate this fact (e.g., blank or "Not Windowed"). The way that AVISIT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for AVISIT. The values and the rules for deriving AVISIT may be different for different parameters within the same dataset. Values of AVISIT are producer-defined, and are often directly usable in Clinical Study Report displays. If a dataset contains more than one record per parameter per subject, then an SDTM or ADaM relative timing variable must be present (AVISIT could meet this requirement).

AVISITN

Analysis Visit (N)

Num

Perm

Numeric representation of AVISIT. Since study visits are usually defined by certain timepoints, defining AVISITN so that it represents the timepoint associated with the visit can facilitate plotting and interpretation of the values. Alternatively, AVISITN may be a protocol visit number, a cycle number, an analysis visit number, or any other number logically related to AVISIT or useful for sorting that is needed for analysis.

There must be a one-to-one relationship between AVISITN and AVISIT (i.e., AVISITN has the same value for each distinct AVISIT) within a parameter. A best practice is to extend the one-to-one relationship to within a study, but this is not an ADaM requirement. In the event that a record does not fall within any predefined analysis timepoint window, AVISITN can be populated in any way that the producer chooses to indicate this fact (e.g., may be null). Values of AVISITN are producer-defined.

AVISITN cannot be present unless AVISIT is also present. On a given record, AVISITN cannot be populated if AVISIT is null. AVISITN can be null when AVISIT is populated, as long as the one-to-one relationship is maintained within a parameter on all rows on which both variables are populated.

ATPT

Analysis Timepoint

Char

Cond

The analysis timepoint description; required if an analysis is done by nominal, assigned or analysis timepoint (instead of or in addition to by-visit). Timepoints are relative to ATPTREF. ATPT may contain the timepoint names as observed (i.e., from SDTM --TPT), derived timepoint names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. This variable

is often used in conjunction with AVISIT. ATPT represents the analysis timepoint of the record. 

ATPT can be within an analysis visit (e.g., blood pressure assessments at 10 min, 20 min, and 30 min post-dose at AVISIT=Week 1) or can be unrelated to AVISIT (e.g., migraine symptoms 30 min, 60 min, and 120 min post-dose for attack 1).

The way that ATPT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for ATPT. The values and the rules for deriving ATPT may be different for different parameters within the same dataset. Values of ATPT are producer-defined, and are often directly usable in Clinical Study Report displays.

If a dataset contains more than one record per parameter per subject, then an SDTM or ADaM relative timing variable must be present (ATPT could meet this requirement).

ATPTN

Analysis Timepoint (N)

Num

Perm

Numeric representation of ATPT. Defining ATPTN so that its values represent the planned timepoints (e.g., minutes or hours after dosing) is not required but can facilitate plotting and interpretation of the values. There must be a one-to-one relationship between ATPTN and ATPT within a parameter. (Best practice would dictate that the mapping would be one-to-one within a study, but that is not an ADaM requirement.)

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

ATPTREF

Analysis Timepoint Reference

Char

Perm

Description of the fixed reference point referred to by ATPT/ATPTN (e.g., time of dose).

APHASE

Phase

Char

Perm

APHASE is a categorization of timing within a study, for example a higher-level categorization of APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON TREATMENT, and FOLLOW-UP. APHASE may be used alone or in addition to APERIOD. APHASE is independent of TRTxxP within ADSL. APHASE may be populated for spans of time where a subject is not on treatment. The value of APHASE (if populated) must be one of the values found in the ADSL

APHASEw variables.

APHASEN

Phase (N)

Num

Perm

Numeric representation of APHASE. The value of APHASEN (if populated) must be one of the w values found in the ADSL APHASEw variable names. There must be a one-to-one relationship between APHASEN and APHASE within a study, which must be the same as the one-to-one mapping between w and APHASEw in ADSL.

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

APERIOD

Period

Num

Cond

APERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variable names. APERIOD is required if ASPER is present. APERIOD must be populated on all records where ASPER is populated.

APERIODC

Period (C)

Char

Perm

Text characterizing to which analysis period the record belongs. There must be a one-to-one relationship between APERIODC and APERIOD within a study.

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

ASPER

Subperiod within Period

Num

Perm

The numeric value characterizing a sublevel within APERIOD to which the record belongs. Within each APERIOD, the first ASPER is 1 (i.e., it resets to 1 when the APERIOD value changes). The value of ASPER (if populated) must be one of the w values found in the ADSL PxxSw variable names.

ASPERC

Subperiod within Period (C)

Char

Perm

Text characterizing to which subperiod the record belongs. There must be a one-to-one relationship between ASPERC and ASPER within a value of APERIOD, which must be the same as the one-to-one mapping between PxxSw and w in ADSL, where xx is equal to the value of APERIOD. The value of ASPERC (if populated) must be one of the values found in the ADSL PxxSw variables.

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

ARELTM

Analysis Relative Time

Num

Perm

The time relative to an anchor time. The amount of time from an anchor time to ATM. When ARELTM is

present, the anchor time variable and ARELTMU must also be included in the dataset, and the anchor time variable must be identified in the metadata for ARELTM.

ARELTMU

Analysis Relative Time Unit

Char

Perm

The units of ARELTM. For example, "HOURS" or "MINUTES." ARELTMU is required if ARELTM is present.

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

APERSDT

Period Start Date

Num

Perm

The starting date for the period defined by APERIOD.

APERSTM

Period Start Time

Num

Perm

The starting time for the period defined by APERIOD.

APERSDTM

Period Start Datetime

Num

Perm

The starting datetime for the period defined by APERIOD.

APERSDTF

Period Start Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of period start date. If APERSDT (or the date part of APERSDTM) was imputed, APERSDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

APERSTMF

Period Start Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of period start time. If APERSTM (or the time part of APERSDTM) was imputed, APERSTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag

Variables.

APEREDT

Period End Date

Num

Perm

The ending date for the period defined by APERIOD.

APERETM

Period End Time

Num

Perm

The ending time for the period defined by APERIOD.

APEREDTM

Period End Datetime

Num

Perm

The ending datetime for the period defined by APERIOD.

APEREDTF

Period End Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of period end date. If APEREDT (or the date part of APEREDTM) was imputed, APEREDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

APERETMF

Period End Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of period end time. If APERETM (or the time part of APEREDTM) was imputed,

APERETMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

ASPRSDT

Subperiod Start Date

Num

Perm

The starting date for the subperiod defined by ASPER.

ASPRSTM

Subperiod Start Time

Num

Perm

The starting time for the subperiod defined by ASPER.

ASPRSDTM

Subperiod Start Datetime

Num

Perm

The starting datetime for the subperiod defined by ASPER.

ASPRSDTF

Subperiod Start Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of subperiod start date. If ASPRSDT (or the date part of ASPRSDTM) was imputed, ASPRSDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation

Flag Variables.

ASPRSTMF

Subperiod Start Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of subperiod start time. If ASPRSTM (or the time part of ASPRSDTM) was imputed, ASPRSTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

ASPREDT

Subperiod End Date

Num

Perm

The ending date for the subperiod defined by ASPER.

ASPRETM

Subperiod End Time

Num

Perm

The ending time for the subperiod defined by ASPER.

ASPREDTM

Subperiod End Datetime

Num

Perm

The ending datetime for the subperiod defined by ASPER.

ASPREDTF

Subperiod End Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of subperiod end date. If ASPREDT (or the date part of ASPREDTM) was imputed,

ASPREDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

ASPRETMF

Subperiod End Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of subperiod end time. If ASPRETM (or the time part of ASPREDTM) was imputed,

ASPRETMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

PHSDT

Phase Start Date

Num

Perm

The starting date for the phase defined by APHASE.

PHSTM

Phase Start Time

Num

Perm

The starting time for the phase defined by APHASE.

PHSDTM

Phase Start Datetime

Num

Perm

The starting datetime for the phase defined by APHASE.

PHSDTF

Phase Start Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of phase start date. If PHSDT (or the date part of PHSDTM) was imputed, PHSDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

PHSTMF

Phase Start Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of phase start time. If PHSTM (or the time part of PHSDTM) was imputed, PHSTMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

PHEDT

Phase End Date

Num

Perm

The ending date for the phase defined by APHASE.

PHETM

Phase End Time

Num

Perm

The ending time for the phase defined by APHASE.

PHEDTM

Phase End Datetime

Num

Perm

The ending datetime for the phase defined by APHASE.

PHEDTF

Phase End Date Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of phase end date. If PHEDT (or the date part of PHEDTM) was imputed, PHEDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

PHETMF

Phase End Time Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of phase end time. If PHETM (or the time part of PHEDTM) was imputed, PHETMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

VariableName

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

*DT

{Date}

Num

Perm

Analysis date not directly characterizing AVAL and/or AVALC in numeric format.

*TM

{Time}

Num

Perm

Analysis time not directly characterizing AVAL and/or AVALC in numeric format.

*DTM

{Datetime}

Num

Perm

Analysis datetime not directly characterizing AVAL and/or AVALC in numeric format.

*ADY

{Relative Day}

Num

Perm

Analysis relative day not directly characterizing AVAL and/or AVALC.

*DTF

{Date Imputation Flag}

Char

(DATEFL)

Cond

The level of imputation of *DT. If *DT (or the date part of *DTM) was imputed, *DTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

*TMF

{Time Imputation Flag}

Char

(TIMEFL)

Cond

The level of imputation of *TM. If *TM (or the time part of *DTM) was imputed, *TMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

*SDT

{Start Date}

Num

Perm

Starting analysis date not directly characterizing AVAL and/or AVALC in numeric format.

*STM

{Start Time}

Num

Perm

Starting analysis time not directly characterizing AVAL and/or AVALC in numeric format.

*SDTM

{Start Datetime}

Num

Perm

Starting analysis datetime not directly characterizing AVAL and/or AVALC in numeric format.

*SDY

{Relative Start Day}

Num

Perm

Starting analysis relative day not directly characterizing AVAL and/or AVALC.

*SDTF

{Start Date Imputation Flag}

Char

(DATEFL)

Cond

The level of imputation of *SDT. If *SDT (or the date part of *SDTM) was imputed, *SDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

*STMF

{Start Time Imputation Flag}

Char

(TIMEFL)

Cond

The level of imputation of *STM. If *STM (or the time part of *SDTM) was imputed, *STMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

*EDT

{End Date}

Num

Perm

Ending analysis date not directly characterizing AVAL and/or AVALC in numeric format.

*ETM

{End Time}

Num

Perm

Ending analysis time not directly characterizing AVAL and/or AVALC in numeric format.

*EDTM

{End Datetime}

Num

Perm

Ending analysis datetime not directly characterizing AVAL and/or AVALC in numeric format.

*EDY

{Relative End Day}

Num

Perm

Ending analysis relative day not directly characterizing AVAL and/or AVALC.

*EDTF

{End Date Imputation Flag}

Char

(DATEFL)

Cond

The level of imputation of *EDT. If *EDT (or the date part of *EDTM) was imputed, *EDTF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.

*ETMF

{End Time Imputation Flag}

Char

(TIMEFL)

Cond

The level of imputation of *ETM. If *ETM (or the time part of *EDTM) was imputed, *ETMF must be populated and is required. See Section 3.1.3, Date and Time Imputation Flag Variables.