PMID- 26821803
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181113
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 18
IP  - 2
DP  - 2016 Mar
TI  - Sample Management: Recommendation for Best Practices and Harmonization from the 
      Global Bioanalysis Consortium Harmonization Team.
PG  - 290-3
LID - 10.1208/s12248-016-9869-2 [doi]
AB  - 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 "room temperature," 
      "refrigerator," "freezer," and "ultra-freezer" that have defined and 
      industry-wide accepted temperature ranges. 5. At the end of the study, 
      documentation of the samples' disposal is required.
FAU - Redrup, Michael J
AU  - Redrup MJ
AD  - Quotient Bio Analytical Sciences (an LGC company), Newmarket, UK.
FAU - Igarashi, Harue
AU  - Igarashi H
AD  - GlaxoSmithKline K. K., Tokyo, Japan.
FAU - Schaefgen, Jay
AU  - Schaefgen J
AD  - PPD, Middleton, Wisconsin, USA.
FAU - Lin, Jenny
AU  - Lin J
AD  - CMIC, Inc, 2860 Forbs Avenue, Hoffman Estates, Illinois, 60192, USA. 
      jenny-lin@cmicgroup.com.
FAU - Geisler, Lisa
AU  - Geisler L
AD  - Covance, Madison, Wisconsin, USA.
FAU - Ben M'Barek, Mohamed
AU  - Ben M'Barek M
AD  - NIBR, Novartis Pharma AG, Basel, Switzerland.
FAU - Ramachandran, Subramanian
AU  - Ramachandran S
AD  - Clinigene International Ltd (a Syngene company), Bangalore, India.
FAU - Cardoso, Thales
AU  - Cardoso T
AD  - Waters Technologies do Brasil, Barueri, Brazil.
FAU - Hillewaert, Vera
AU  - Hillewaert V
AD  - Jansen R&D, Beerse, Belgium.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20160128
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
SB  - IM
MH  - Biological Specimen Banks/*standards
MH  - Congresses as Topic/standards
MH  - Humans
MH  - Internationality
MH  - Medical Laboratory Science/methods/*standards
MH  - Specimen Handling/methods/*standards
PMC - PMC4779093
OTO - NOTNLM
OT  - LIMS
OT  - sample collection
OT  - sample disposal
OT  - sample management
OT  - sample storage
EDAT- 2016/01/30 06:00
MHDA- 2016/12/15 06:00
PMCR- 2017/01/28
CRDT- 2016/01/30 06:00
PHST- 2015/06/02 00:00 [received]
PHST- 2016/01/07 00:00 [accepted]
PHST- 2016/01/30 06:00 [entrez]
PHST- 2016/01/30 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2017/01/28 00:00 [pmc-release]
AID - 10.1208/s12248-016-9869-2 [pii]
AID - 9869 [pii]
AID - 10.1208/s12248-016-9869-2 [doi]
PST - ppublish
SO  - AAPS J. 2016 Mar;18(2):290-3. doi: 10.1208/s12248-016-9869-2. Epub 2016 Jan 28.