Policy Number

15.03

IWK - 15.03 Record Retention for Investigational Agents

Description

All original source documents and records respecting the shipment, receipt, dispensation, return and destruction of investigational agents not marketed in Canada at the time of their use in a clinical trial or for patients following a clinical trial will be maintained for a minimum of 25 years as per Division 5 of the Regulations to the Health Canada Food and Drug Act.