Document Detail


Institution/investigator-initiated clinical trials in Canada.
MedLine Citation:
PMID:  16873897     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Institution/investigator-initiated clinical trials in Canada require adherence to similar regulations and processes required of large pharmaceutical manufacturers. This may require an investigator to file a Clinical Trial Application. This article outlines the responsibilities and actions that are required prior to, during, and after the conduct of an institution/investigator initiated trial.
Authors:
Jan Sedgeworth; Lidia Derewlany
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Publication Detail:
Type:  Journal Article     Date:  2006-07-25
Journal Detail:
Title:  The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique     Volume:  13     ISSN:  1710-6222     ISO Abbreviation:  Can J Clin Pharmacol     Publication Date:  2006  
Date Detail:
Created Date:  2006-07-28     Completed Date:  2006-09-28     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9804162     Medline TA:  Can J Clin Pharmacol     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  e236-9     Citation Subset:  IM    
Affiliation:
Carexa Inc., Oakville, Canada, 2Ceruleus Inc. Toronto, Canada. jsedgeworth@carexa.com
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MeSH Terms
Descriptor/Qualifier:
Canada
Clinical Trials Data Monitoring Committees
Drug Industry / methods,  standards*
Health Facilities / standards*
Humans
Randomized Controlled Trials as Topic / methods,  standards*
Research Personnel / standards*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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