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Description/Overview

Information about sampling for pharmacokinetic (PK) concentration is collected on CRFs with the goal to reconcile or link sampling information (e.g., collection timing and specimen volumes) with PK concentration results provided by the laboratory. SDTMIG PC records are compiled when joining CRF sampling information and PK concentration results. This is similar to scenario 1 in Section 8.3.6, Laboratory Test Results.

The goals of the CDASHIG PC domain are:

• To standardize specimen collection details in the CRF for PK samples collected at fixed time points or over timed intervals
• To provide CDASHIG examples as to the collection of data that is closely related to PK sampling (e.g., subject's most recent exposure to study treatment, exposure record considered to be the reference for timed PK samples)
• To document the data flow from the CDASHIG CRF to the SDTMIG PC dataset

The CDASHIG PC domain defines fields for:

1. The date and time of PK sample collections for the scenarios listed below. Note that the sampling approach may depend on how the body metabolizes and clears the analyte.
   1. Fixed defined time points (e.g., 4 HRS POSTDOSE)
   2. Across a collection interval (e.g., 2-4 HRS POSTDOSE)
2. Sample properties (e.g., pH, sample volume)

Note that samples collected to measure drug concentration at an instant in time are generally associated with specimen types such as plasma, serum, or whole blood. Samples collected over a timed interval are generally associated with specimen types such as urine or feces.

PK Sample Collection at Fixed Time Points

In the case of fixed time points, the date (PCDAT) and time (PCTIM) of collection for each sample is recorded on the CRF. The protocol defines the time points at which samples are to be collected in relation to an intervention such as a dose of study treatment. This "reference" is depicted in Figure 1 by the longer vertical line and would correspond to a date and time in the Exposure as Collected (EC) or Exposure (EX) domain.

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PK Sample Collection Over a Time Interval

Similarly, for PK specimens collected to measure drug excretion over a time interval, PCDAT and PCTIM capture the start date and time of the interval collection. End date (PCENDAT) and end time (PCENTIM) capture the end of the timed interval collection. As with fixed-time point collections, these timed intervals are performed in relation to an intervention such as a dose of study treatment. This "reference" is depicted in Figure 2 by the longer vertical line and would correspond to a date and time in the EC or EX domain.

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CM.CDASHIG-SDTMIG PK Data Flow

The concept map in Figure 3 illustrates the data flow from PK sample collection at the site through the tabulation of PK concentration and PK parameter results.

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Specification

Assumptions

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