| 000 | 00000nam 2200000zi 4500 |
| 001 | 9.937242 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20240611110231 |
|---|
| 006 | m o d f |
|---|
| 007 | cr |n||||||||| |
|---|
| 008 | 240419e20120328onc ob f|0| 0 eng d |
|---|
| 040 | |aCaOODSP|beng|erda|cCaOODSP |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH14-610/2012E-PDF |
|---|
| 245 | 00|aSummary report of the inspections of clinical trials conducted from April 2004 to March 2011 / |cHealth Products and Food Branch Inspectorate. |
|---|
| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cMarch 28, 2012. |
|---|
| 300 | |a1 online resource (15 pages) : |bcharts |
|---|
| 336 | |atext|btxt|2rdacontent |
|---|
| 337 | |acomputer|bc|2rdamedia |
|---|
| 338 | |aonline resource|bcr|2rdacarrier |
|---|
| 500 | |aIssued also in French under title: Rapport sommaire des inspections d’essais cliniques réalisées d’avril 2004 à mars 2011. |
|---|
| 500 | |aCover title. |
|---|
| 504 | |aIncludes bibliographical references (page 15). |
|---|
| 520 | |a"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. |
|---|
| 650 | 0|aClinical trials|zCanada. |
|---|
| 710 | 1 |aCanada.|bHealth Canada. |bHealth Products and Food Branch Inspectorate, |eissuing body. |
|---|
| 775 | 08|tRapport sommaire des inspections d'essais cliniques réalisées d'avril 2004 à mars 2011 / |w(CaOODSP)9.937243 |
|---|
| 856 | 40|qPDF|s445 KB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H14-610-2012-eng.pdf |
|---|
| 856 | 41|qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/reports/summary-report-inspections-clinical-trials-conducted-april-2004-march-2011.html |
|---|