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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.937242&sl=0
| Department/Agency | Canada. Health Canada. Health Products and Food Branch Inspectorate, issuing body. |
|---|---|
| Title | Summary report of the inspections of clinical trials conducted from April 2004 to March 2011 / Health Products and Food Branch Inspectorate. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| 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). |
| Publishing information | [Ottawa] : Health Canada = Santé Canada, March 28, 2012. |
| Description | 1 online resource (15 pages) : charts |
| Catalogue number |
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| Subject terms | Clinical trials -- Canada. |
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