Pharmacokinetics Sampling at Fixed Time Points


The CDASHIG PC domain defines fields for

  1. 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.
  2. Sample properties (e.g., pH, sample volume)

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 example is for a blood draw. The user will need to update the planned time points and specimen type, as appropriate. If the date carries over to the next calendar day, consider collecting the date in the repeating section or on another form.


"Form PC - PK Sample Collection at Fixed Time Points - Blood Draw [PC_FIXTIME]" Form Preview
Form PC - PK Sample Collection at Fixed Time Points - Blood Draw
PC - PK Sample Collection at Fixed Time Points - Blood Draw
Were PK samples collected? No  Yes  
What was the date of the PK sample collection?
 01 Jan 2000
What was the reason the PK sample was not collected?
Was the subject fasting? No  Yes  
What was the (PK) [reference identifier/accession number]?
What was the specimen (material) type?
PC - PK Sample Collection at Fixed Time Points - Blood Draw
What was the planned time point of the PK sample collection? What was the time of the PK sample collection?
Pre-Dose 
 12:00
Hour 1 
 12:00
Hour 2 
 12:00
Hour 3 
 12:00
* Mandatory field

Package(s)
PC_FIXED_TIME_POINT_eCRF_Package