Introduction

Urine is often collected in order to understand the pharmacokinetics (‘PK’) of a medicine ('drug'). Urine can be collected and stored for extended periods of an in-house stay. Those periods are split down into shorter ‘intervals’. Urine is typically expected to be kept refrigerated in order to slow down or prevent any metabolic activity (‘breakdown’ or degradation) of the medicine until samples can be taken and frozen for subsequent drug concentration analysis.

Terminology

Interval

A period of time in which urine is collected.

For example:

• -2h ⇒ 0h

• 0h ⇒ 2h

• 2h ⇒ 4h

• 4h ⇒ 8h

• 8h ⇒ 16h

• 16h ⇒ 24h

Void (or Collection) Containers

Open

‘Urinal'

Open

‘Hat'

• A 'container' that is used temporarily to collect a void of urine that is added to an interval or storage container.

• These void containers are barcoded to ensure that the right void goes with the right interval container for the right subject.

• Sometimes the same void container is used in an interval, or, new void containers are used for each void. 

Interval (or Storage) Containers

• These are the containers (also sometimes called ‘jugs’ or pooling container) that are used to store the cumulative voids for the designated interval (in the fridge, etc).

• The number of containers needed for an interval is unknown. If a subject is passing a lot of urine, they may need to use several containers for an interval.
  
  

Start Interval

Within Data Collection:

1. Scan Start Event barcode label on the interval container to open event (or open event manually > Interval PK Start form)

2. Scan subject wristband to verify correct subject

3. Scan internal container Start Barcode again

   • Container is confirmed to belong to the subject for that collection interval

   • Document the start date/time of interval  

4. Store container for use within the interval

ClinSpark Video Walkthrough

Collect Urine Void in Interval

Within Data Collection:

1. Scan subject wristband

2. Press “Add New” within form to add a new void

3. Scan urinal (void container) as applicable

   • Void container is confirmed to belong to the subject for that interval collection

4. Subject voids and time of collection is documented 

4. Scan barcode on interval collection container

5. Scan urinal or hat as applicable 

ClinSpark Video Walkthrough

Add contents of Void Container to Interval Container

1. Interval Collection Container is confirmed to match the void container for that interval for that subject.

2. Poor freshly voided urine into the interval container

3. Place the interval container into the fridge

4. Rinse and retain the urinal for the next void OR

   1. A new void container is provided each time a subject voids

   2. Repeat as necessary until the end of the interval.

End Interval

Within Data Collection

1. Scan Stop Event barcode label on interval container to open event (or open event manually > Interval PK Stop form)

2. Scan subject wristband to verify correct subject

   • Container is confirmed to belong to the subject for that interval

   • Document interval end date/time

3. Measure volume of total amount of urine collected in the interval and record this on the Stop Event form

4. Mix pooled collection thoroughly

Within Sample Processing

1. Scan Stop Event Label

2. Scan urine aliquot tubes for the interval

3. Transfer applicable quantities of urine to the urine aliquot containers.

4. Using the scanner at each step, pack the aliquots into appropriate containers and place them in the applicable freezer.

Clinspark Video Walkthrough