Evidence map›Paper›PMID 30339188›Full record

ArticleAmerican journal of clinical pathology2019

Implementation of Good Clinical Laboratory Practice in an Immunology Basic Research Laboratory: The KEMRI-Wellcome Trust Research Laboratories Experience.

Horace Gumba, Jennifer Musyoki, Moses Mosobo, Brett Lowe

Abstract read
In one paragraph

Article in American journal of clinical pathology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

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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

4 authors.

Horace GumbaKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Jennifer MusyokiKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Moses MosoboKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Brett LoweCentre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Good Clinical Laboratory Practice (GCLP) is a standard that ensures quality and reliability of research data by adopting the principles of Good Laboratory Practice and Good Clinical Practice. Even though implementing a quality system in a basic research laboratory is still a contentious issue, it ensures that the research data are accurate, valid, and reliable. GCLP implementation requires proper documented procedures and safety precautions to achieve this objective. Methods: This article describes the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Laboratories experience in the implementation of GCLP guidelines in a laboratory conducting basic research. Results: The laboratory managed to implement GCLP elements that could be applied to a basic research laboratory, such as standard operating procedures, equipment management, laboratory analytical plans, organization, and personnel. The laboratory achieved GCLP accreditation in October 2015. Conclusions: The methodology, suggestions, and comments that arose from our experience in implementing GCLP guidelines can be used by other laboratories to develop a quality system using GCLP guidelines to support medical research conducted to ensure the research data are reliable and can be easily reconstructed in other research settings.

Indexed as

Practice Guidelines as TopicAcademies and InstitutesAccreditationClinical Laboratory TechniquesHumansKenyaLaboratoriesQuality Assurance, Health CareReproducibility of Results

Identifiers

PMID30339188
PMCPMC6360634

What OpenQuestion holds

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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.