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Summary report of the inspections of clinical trials conducted from April 2004 to March 2011 / Health Products and Food Branch Inspectorate. : H14-610/2012E-PDF

"Inspections of clinical trials are conducted to strengthen the protection of the rights and safety of clinical trial participants and validate the integrity of the data generated through the conduct of clinical trials. This is done by assessing that the generally accepted principles of Good Clinical Practices are met, and by verifying compliance with Division 5 of Part C of the Food and Drug Regulations. The objective of sharing inspection results, including observations noted during inspections, in an anonymous manner in this report is to increase awareness of Canadian regulatory requirements within the clinical research community, while maintaining the confidentiality and privacy of those involved in the inspections"--Executive Summary, page 3.

Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.937242&sl=1

Renseignements sur la publication
Ministère/Organisme
  • Canada. Health Canada. Health Products and Food Branch Inspectorate, issuing body.
TitreSummary report of the inspections of clinical trials conducted from April 2004 to March 2011 / Health Products and Food Branch Inspectorate.
Type de publicationMonographie
Langue[Anglais]
Autres langues publiées[Français]
FormatTexte numérique
Document électronique
Note(s)
  • Issued also in French under title: Rapport sommaire des inspections d’essais cliniques réalisées d’avril 2004 à mars 2011.
  • Cover title.
  • Includes bibliographical references (page 15).
Information sur la publication
  • [Ottawa] : Health Canada = Santé Canada, March 28, 2012.
Description1 online resource (15 pages) : charts
Numéro de catalogue
  • H14-610/2012E-PDF
Descripteurs
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