good clinical practice


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good clinical practice

A term of art used in clinical trials for the standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
References in periodicals archive ?
Who Guidelines for Good Clinical Practices (GCP) for Trials on Pharmaceutical Products.
Guidelines for Principles and Essentials of Good Clinical Practices of Advanced Treatment Medicinal Products
The main objective of this study was to show the effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers, Govt.
22) If REB review does not take place in accordance with the ICH-GCP, it could be argued that good clinical practice is not being respected and that a trial authorized by an inappropriately functioning REB ought to be suspended.
From this subset of studies, it is evident that the general practice among the clinical testing laboratories currently employed by pesticide manufacturers is to conduct studies in accordance with the two most commonly followed ethical guidelines for human studies by nongovernmental entities, the Declaration of Helsinki (World Medical Association 2002) and the international guidelines for good clinical practice (FDA 1997).
To this end, the Commission is working with national governments in bringing forward the implementation of rules on good clinical practice, which will complete the legal framework and explain how the rules should be applied on the ground.
The Pharmaceutical/Biotechnology unit publishes the magazines Scrip, Good Clinical Practice Journal and BioPeople; newsletters Scrip World Pharmaceutical News, Scrip's Target World Drug Delivery News, BioVenture View, BioCommerce Abstracts and, Scrip Daily News Alert, an daily e-mail.
This side of the business has been particularly attractive to Japanese pharmaceutical companies that are working to become internationally competitive and meet the stringent requirements of good clinical practice standards for clinical trials.
As a link between relationship-centered care and evidence-based medicine, mindfulness should be considered a characteristic of good clinical practice," Dr.
The unit has been inspected by the US Food and Drug Administration (FDA) for compliance with international Good Clinical Practice and Good Laboratory Practice and operates at the high quality standards required for international drug development.
In the practice of medicine, good clinical practice is generally understood to encompass professional behaviors including employing the accepted standard of care to patients.
The failure to make appropriate and timed contingency plans for Daniel's after-care falls short of good clinical practice and responsibility for this rests with the NDS, despite the involvement of two other health authorities and social services.