Evidence map›Paper›PMID 35822767›Full record

ArticleBiotech (Basel (Switzerland))2021

New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks.

Pasquale De Blasio, Ida Biunno

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Biotech (Basel (Switzerland)), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
5.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Pasquale De BlasioIntegrated Systems Engineering Srl, c/o OpenZone, Via Meucci 3, 20091 Bresso, MI, Italy.
Ida BiunnoIntegrated Systems Engineering Srl, c/o OpenZone, Via Meucci 3, 20091 Bresso, MI, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe emergence of "multi-omics" and "multi-parametric" types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality

methodsThe accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks.

resultsThe accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines.

conclusionAccreditation is given by an accreditation body, which recognizes formally that the Biobank is "competent to carry out specific Biobanking tasks".

Indexed as

accreditationbiobanking engineeringbiobankscertificationISO 20387:2018ISO 9001:2015QMSquality management systems

Identifiers

PMID35822767
PMCPMC9245471
OpenAlexW3175577406

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.