Good clinical practice and audits for dual X-ray absorptiometry and X-ray imaging laboratories and quality assurance centers involved in clinical drug trials, private practice, and research.

Détails

ID Serval
serval:BIB_7995AB133CD1
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
Good clinical practice and audits for dual X-ray absorptiometry and X-ray imaging laboratories and quality assurance centers involved in clinical drug trials, private practice, and research.
Périodique
Journal of Clinical Densitometry
Auteur(s)
Blunt B.A., Jones D., Svensen R.K., Hans D.B., Feinblatt J.D., Genant H.K.
ISSN
1094-6950
Statut éditorial
Publié
Date de publication
1998
Peer-reviewed
Oui
Volume
1
Numéro
4
Pages
323-337
Langue
anglais
Notes
Publication types: Journal Article
Résumé
Good Clinical Practice (GCP) guidelines, with an emphasis on quality and validation of processes and data, must be applied to the use of imaging in clinical drug development. All participants, including the sponsor, principal investigator, site staff, quality assurance centers, and contract research organizations, must be cognizant of the need for application of these principles to their activities related to the imaging programs. This article discusses the various aspects of GCP as they need to be applied to the use of dual X-ray absorptiometry (DXA) for bone densitometry and X-rays for vertebral fracture assessment in clinical trials for osteoporosis, as well as research and private practice settings. The theory of proper audit conduct to verify clinical trial data is presented.
Mots-clé
Osteoporosis
Pubmed
Web of science
Création de la notice
02/03/2009 13:33
Dernière modification de la notice
03/03/2018 18:32
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