Lab sample storage for clinical trials is maybe one of the areas, which clinical trials teams neglect. However, often inadequate storage could result in audit findings.

Unless the clinical trial requires lab samples to be sent to Central Lab for analysis the same day, usually the lab samples are stored in local facility. 

What are the common issues with lab sample storage?

  • Inadequate labeling – if the lab samples are not labeled correctly, they can be mixed up during the storage. This could compromise significant amount of lab sample data.
  • Lack of temperature monitoring – this is a common issue. Lab fridges used to store lab samples should have temperature monitoring and temperature deviations should be reported to the Sponsor. Clinical trials team should have back-up plan in case of fridge faults.
  • Samples stored at wrong temperature – always check you lab manual to assure the samples are stored at correct temperature and data is not compromised.
  • Lab fridges used to store different materials – this is another common issue. Ideally lab fridges should be used only for clinical trials samples, however if this is not possible, shelves with samples should be clearly marked.
  • Extensive storage – sometimes lab samples are stored longer than lab manual recommendations. It is desirable lab samples to be sent on a regular basis to Central Lab to avoid compromising samples.
  • Back-up samples – often studies require back-up samples to be kept locally, however it is common that these samples are missed or misplaced. 

How to avoid lab storage issues?

  • Make sure you have procedure for clinical trials lab sample storage and contingency plan in case of faults.
  • Make sure you have adequate temperature monitoring system and readings are taken regularly. 
  • Keep samples from different patients and clinical trials clearly labeled and separated.
  • Send samples to Central Lab regularly and check if your back-up samples are properly labeled.

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 4 Jan 2016