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

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

• These void containers are barcoded to ensure that the right void goes with the right interval collection 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 interval container 'jugs' containers (also sometimes called ‘jugs’ or pooling container) that are used to store the void in (for the cumulative voids for the designated interval (in the fridge, etc).

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

Start Interval

Within Data Collection:

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

2. Scan subject wristband to verify correct subject

3. Scan Container 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

Pooling

Add contents of Void Container

to Interval

Container

1. Pooling (Interval Collection ) Container is confirmed to match the urinal ( void container ) for that interval collection for that subject.

2. Poor freshly voided urine into the pooling interval container

3. Place the pooling 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 pooling 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 collection 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