3.3.3.1 BDS Timing Variables (Copy)

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.

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).

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.

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.

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 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.

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.

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.

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.