- Created by Nate Freimark, last modified by Lorraine Sobson on Oct 14, 2023
Any SDTM timing variable (including, but not limited to EPOCH, --DTC, --DY, VISITNUM, VISIT, and VISITDY) may be copied into ADaM datasets when it supports data traceability and/or shows how ADaM timing variables contrast with SDTM timing data. If a dataset contains more than 1 record within a parameter and within a subject, then an SDTM or ADaM relative timing variable must be present (eg, ADY, ASTDY, AENDY, AVISIT, ATPT).
ADaMIG Table 3.3.3.1 defines analysis timing variables for BDS datasets. The timing variables whose names start with the letter A are the timing variables directly associated with the AVAL and AVALC variables in the ADaM dataset.
A variable for relative day of measurement or event, along with timing variables for visit, should be included when an ADaM dataset contains multiple records per subject (i.e., repeated measures data).
Timing variables not directly characterizing AVAL (e.g., *DT) should be prefixed by a character string instead of the placeholder asterisk shown in ADaMIG Table 3.3.3.3, so that their actual names comply with the variable naming conventions described in Section 2.9.3.1, General Variable Conventions. In many cases, the prefix for these date and time variables would match that of an SDTM --DTC, --STDTC or --ENDTC variable name. For example, if a numeric date variable were created from --STDTC, then it would be named --SDT. However, if --DTC or --STDTC is the date that is associated with AVAL and AVALC, its numeric equivalent should be named ADT or ASTDT, as appropriate. The timing variable conventions documented in Section 2.9.3.2, Timing Variable Conventions, apply here as well.
| 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 Section 2.9.3.2, 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 (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 Section 2.9.3.3, 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 Section 2.9.3.3, 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. See Section 2.9.3.2, 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 (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 Section 2.9.3.3, 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 Section 2.9.3.3, Date and Time Imputation Flag Variables. |
| AENDT | Analysis End Date | Num | Cond | The end date associated with AVAL and/or AVALC. See also ASTDT. If both ASTDT and AENDT are populated then ASTDT must less than or equal to AENDT. | |
| 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. If both ASTDTM and AENDTM are populated then ASTDTM must less than or equal to AENDTM. | |
| AENDY | Analysis End Relative Day | Num | Cond | The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT. See Section 2.9.3.2, Timing Variable Conventions. If a dataset contains more than 1 record per parameter per subject, then an SDTM or ADaM relative timing variable must be present (AENDY would meet this requirement). If both ASTDY and AENDY are populated then ASTDY must be less than or equal to AENDY | |
| 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 Section 2.9.3.3, 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 Section 2.9.3.3, 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 2.9.6.10, 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 PRODUCT, 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 product. 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. |
Period, Subperiod, and Phase Start and End Timing Variables
Additional timing variables can be included for phase, period, and subperiod. The values of period, subperiod, and phase start (and end) timing variables must be consistent with their subject-level counterparts from ADSL.
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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, Date and Time Imputation Flag Variables . |
Suffixes for Producer-defined Timing Variables in BDS Datasets
| Variable Name | 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, 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 2.9.3.3, Date and Time Imputation Flag Variables. |
| *EDT | {End Date} | Num | Perm | Ending analysis date not directly characterizing AVAL and/or AVALC in numeric format. If both *SDT and *EDT are populated then *SDT must be less than or equal to *EDT. | |
| *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. If both *SDTM and *EDTM are populated then *SDTM must be less than or equal to *EDTM. | |
| *EDY | {Relative End Day} | Num | Perm | Ending analysis relative day not directly characterizing AVAL and/or AVALC. If both *SDY and *EDY are populated then *SDY must be less than or equal to *EDY | |
| *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 2.9.3.3, 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 2.9.3.3, Date and Time Imputation Flag Variables. |
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