Institution/investigator-initiated clinical trials in Canada.
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.
Sedgeworth
Jan
J
Carexa Inc., Oakville, Canada, 2Ceruleus Inc. Toronto, Canada. jsedgeworth@carexa.com
Derewlany
Lidia
L
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*