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CMIC Resources

CMIC Resources

[Journal Article] Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The importance of appropriate sample management in regulated bioanalysis is undeniable for
clinical and non-clinical study support due to the fact that if the samples are compromised at any stage
prior to analysis, the study results may be affected. Health authority regulations do not contain specific
guidance on sample management; therefore, as part of the Global Bioanalysis Consortium (GBC), the
A5 team was established to discuss sample management requirements and to put forward recommendations.

The recommendations from the team concern the entire life span of the sample and include the following:

  1. Sampling procedures should be described in the protocol or within the laboratory manual. This
    information should include the volume of the sample to be collected, the required
    anticoagulant, light sensitivity, collection and storage containers, and labeling with a unique
    identifier.
  2. The correct procedures for processing and then storing the samples after collection at the
    clinical/non-clinical testing site and during shipment are also very important to ensure the
    analyte(s) stability and should be documented.
  3. Chain of custody for the samples must be maintained throughout the complete life span of each
    sample. This is typically maintained via paper and electronic data systems, including Laboratory
    Information Management Systems (LIMS) where available.
  4. Pre- and post-analysis storage location and conditions must also be clearly defined at the
    analytical laboratory. The storage temperature of the samples must be traceable and controlled
    by monitoring and warning alerts. The team suggests moving away from using temperatures and
    to adopt standard terminology of Broom temperature,^ Brefrigerator,^ Bfreezer,^ and Bultrafreezer^
    that have defined and industry-wide accepted temperature ranges.
  5. At the end of the study, documentation of the samples’ disposal is required
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