Majority of the clinical trials use external facilities for lab samples analysis and storage. These facilities are knows as Central lab and they are specific for each region (for example, Europe, Asia, South America, etc.). 

Some clinical trials may not require lots of lab samples, however majority of the studies have very complex lab samples requirements. The most common sample requirements are hematology and chemistry panels, but usually there are study specific sample requirements.   

One of the challenges in lab samples handling is that often there are different samples, which should be stored and shipped under different conditions. The most common shipping requirements are: dry ice, ice packs and ambient temperature. 

What do we need to know about lab samples handling health and safety?

  • Dry ice is used for frozen lab samples. It is toxic material and should be handled carefully. People who handle dry ice lab samples should have a special training, usually provided by the hospital or certified agency. Normally dry ice is ordered from the courier 24 hours prior shipping samples. Each clinical trial has specific dry ice order form. 
  • Ice packs are used to keep samples chilled but not frozen. They are safe to use and should be refrigerated overnight before shipping. Usually ice packs are provided by Central lab with lab kits.
  • Ambient samples are shipped at room temperature. 

Lab manuals have detailed information regarding each sample shipping requirements. It is important that these instructions are followed carefully and samples are not compromised.

What are the common issues with lab samples shipping?

  • Samples sent in a wrong shipping box, which results in a delayed delivery or return to the site.
  • Inadequate labeling – missing dry ice label, category B label, etc.
  • Samples arrived on melted dry ice due to delay.
  • Samples shipped at wrong shipping conditions.
  • Samples shipped with inadequate documentation – missing proforma invoice, etc. 

How to avoid shipping mistakes?

  • Lab samples should have the appropriate labeling on the shipping box. Always use the provided shipping boxes for the study to avoid confusions. Always follow the instructions for packaging of ambient, refrigerated and frozen samples.
  • Samples shipped on dry ice should always have dry ice label clearly displayed – UN1845.
  • Make sure you have “Next day delivery” label for samples shipped on dry ice, otherwise delivery could be delayed and dry ice will melt.
  • If you have mix of ambient, frozen and refrigerated samples, always refer to you Central lab manual to avoid mixing up the samples.
  • Make sure you have all proper documents for shipping samples. Missing proforma invoice or other information could cause delivery delays. 
  • Always consider weather conditions – during hot summer days or cold winters there may be different shipping recommendations and you need to check with Central lab and courier to avoid compromising your samples. These temperature deviations are especially important for ambient samples shipping. 

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 2 Nov 2015