Timing variables are copied from the SDTM and derived within ADaM. Common timing variables are provided in this section. If other timing variables are collected in SDTM and pertinent for analysis, these should be included in ADaM. Additional timing variables, such as those for period start and end dates, can be included. For more details on timing variables, see Section 2.9.6.3, Timing Variables for BDS Datasets.

Variable NameVariable Label

Type

Codelist/ Controlled TermsCoreCDISC Notes

--STDTC

Start Date/Time of Observation

Char

ISO 8601 datetime or interval

Cond

Copied from XX.–STDTC

Conditional on whether start date is pertinent for study and is populated in SDTM

This variable label differs depending on the SDTM domain. AESTDTC is required for adverse event data.

ASTDT

Analysis Start Date

Num


Cond

Created from converting XX.--STDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the statistical analysis plan (SAP) or metadata

Conditional on whether start date is pertinent for study and is populated in SDTM. Required for adverse event data.

ASTTM

Analysis Start Time

Num


Cond

Created from converting XX.--STDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata

Conditional on whether start time is pertinent for study and is populated in SDTM

ASTDTM

Analysis Start Datetime

Num


Cond

Created from converting XX.--STDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata

Conditional on whether start datetime is pertinent for study and is populated in SDTM

ASTDTF

Analysis Start Date Imputation Flag

Char

(DATEFL)

Cond

The level of imputation of analysis start date. Imputation flags are described in ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables.

Conditional on whether ASTDT (or the date part of ASTDTM) was imputed

ASTTMF

Analysis Start Time Imputation Flag

Char

(TIMEFL)

Cond

The level of imputation of analysis start time. Imputation flags are described in ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables.

Conditional on whether ASTTM (or the time part of ASTDTM) was imputed

--ENDTC

End Date/Time of Observation

Char

ISO 8601 datetime or interval

Cond

Copied from XX.--ENDTC

Conditional on whether end date is pertinent for study and is populated in SDTM

This variable label differs depending on the SDTM domain. AEENDTC is required for adverse event data.

AENDT

Analysis End Date

Num


Cond

Created from converting XX.--ENDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the SAP or metadata. If both ASTDT and AENDT are populated then ASTDT must less than or equal to AENDT.

Conditional on whether end date is pertinent for study and is populated in SDTM. Required for adverse event data.

AENTM

Analysis End Time

Num


Cond

Created from converting XX.--ENDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata

Conditional on whether end time is pertinent for study and is populated in SDTM

AENDTM

Analysis End Datetime

Num


Cond

Created from converting XX.--ENDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata. If both ASTDTM and AENDTM are populated then ASTDTM must less than or equal to AENDTM.

Conditional on whether end datetime is pertinent for study and is populated in SDTM

AENDTF

Analysis End Date Imputation Flag

Char

(DATEFL)

Cond

The level of imputation of analysis end date. Imputation flags are described in Section 2.9.3.3, Date and Time Imputation Flag Variables.

Conditional on whether AENDT (or the date part of AENDTM) was imputed

AENTMF

Analysis End Time Imputation Flag

Char

(TIMEFL)

Cond

The level of imputation of analysis end time. Imputation flags are described in Section 2.9.3.3, Date and Time Imputation Flag Variables.

Conditional on whether AENTM (or the date part of AENDTM) was imputed

ASTDY

Analysis Start Relative Day

Num


Cond

The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT

Example derivation:
ASTDT - ADSL.TRTSDT + 1 if ASTDT >= ADSL.TRTSDT, else ASTDT - ADSL.TRTSDT if ASTDT< ADSL.TRTSDT

This variable may instead be copied from --STDY.

Conditional on whether analysis start relative day is pertinent to the study. Required for adverse event data.

--STDY

Study Day of Start of Observation*

Num


Perm

Copied from XX.--STDY

ASTDY may differ from --STDY due to date imputation and the option in ADaM to use a reference date other than SDTM’s RFSTDTC. Including XX.--STDY in addition to ASTDY adds traceability.

For SubClass ADVERSE EVENT, conditional on whether the AESTDY variable is in the SDTM AE dataset

AENDY

Analysis End Relative Day

Num


Perm

The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT

Example derivation:
AENDT - ADSL.TRTSDT + 1 if AENDT >= ADSL.TRTSDT, else AENDT - ADSL.TRTSDT if AENDT < ADSL.TRTSDT

This variable may instead be copied from --ENDY.

If both ASTDY and AENDY are populated then ASTDY must be less than or equal to AENDY. Required for adverse event data.

--ENDY

Study Day of End of Observation*

Num


Perm

Copied from XX.--ENDY

AENDY may differ from --ENDY due to date imputation and the option in ADaM to use a reference date other than SDTM’s RFSTDTC. Including XX.--ENDY in addition to AENDY adds traceability.

If both --STDY and --ENDY are populated then --STDY must be less than or equal to --ENDY

For SubClass ADVERSE EVENT, conditional on whether the AEENDY variable is in the SDTM AE dataset

ADURN

Analysis Duration (N)

Num


Perm

Derive from ASTDT (or ASTDTM) and AENDT (or AENDTM).

ADURU

Analysis Duration Units

Char

(UNIT)

Cond

Conditional on whether ADURN is included

--DUR

Duration of XX

Char

ISO 8601 duration

Cond

Copied from XX.--DUR

Because --DUR is a collected field and ADURN is derived, the values will often differ. Including XX.--DUR in addition to ADURN adds traceability.

For SubClass ADVERSE EVENT, conditional on whether the AEDUR variable is in the SDTM AE dataset.

APERIOD

Period

Num


Perm

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 variables. See Section 2.9.6.3, Timing Variables for BDS Datasets, for more information on this variable.

APERIODC

Period (C)

Char


Perm

Text characterizing to which period the record belongs. One-to-one map to APERIOD.

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 PRODUCT, and FOLLOW-UP. 

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