The CDASHIG PC domain defines fields for
- The date and time of PK sample collections, either at fixed defined time points (e.g., 4 HRS POSTDOSE) or across a collection interval (e.g., 2-4 HRS POSTDOSE). How the body metabolizes and clears the analyte often determines which of these sampling approaches may be required. 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.
- Sample properties (e.g., pH, sample volume)
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 is an example for a 24-hour urine collection. The user will need to update the planned time point and specimen type, as appropriate.