Policy Number

15.02

IWK - 15.02 Temperature Monitoring for Investigational Agents

Description

Storage conditions for investigational agents (IAs) used in clinical trials involving human subjects must be in accordance with current standards and manufacturer recommendations.

Medication storage temperatures must be maintained within recommended range to meet the requirements of 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).

.