INSTITUTION / INVESTIGATOR-INITIATED CLINICAL TRIALS IN CANADA

Main Article Content

Jan Sedgeworth
Lidia Derewlany

Keywords

Regulations, clinical trials, Health Canada

Abstract

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.

Abstract 126 | PDF Downloads 124

References

1. Klein AV, Tomalin AM. Clinical trial applications in Canada. Can J Clin Pharmacol Vol 12(3) Fall 2005:e246-e250; Oct. 24, 2005.