Policy Number


IWK - 15.01 Management of Investigational Agents Used in Clinical Trials


Investigational agents used in clinical research trials, regardless of the source (including

those which are commercially available) must be managed in a way to meet the needs

of the Clinical Trial Sponsors and to comply with regulations outlined in Division 5 of the

Health Canada Food and Drug Regulations (Drugs for Clinical Trials Involving Human

Subjects).This policy details procedures for the receipt, storage, distribution,

accountability, and return or authorized destruction of investigational agents.