title: Institution/investigator-initiated clinical trials in 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.
authors.affiliation: Carexa Inc., Oakville, Canada, 2Ceruleus Inc. Toronto, Canada. jsedgeworth@carexa.com
authors.forename: Jan
authors.initials: J
authors.lastname: Sedgeworth
authors.forename: Lidia
authors.initials: L
authors.lastname: Derewlany
mesh_terms: D002170:Canada; D026661:Clinical Trials Data Monitoring Committees; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D006268:Health Facilities / Q000592:standards*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012108:Research Personnel / Q000592:standards*