Policy Number

15.05

IWK - 15.05 Management of NCI Supplied Investigational Agents

Description

Investigational agents supplied through the Pharmaceutical Management Branch of the Cancer Therapy Evaluation Program (CTEP) [a Division of Cancer Treatment and Diagnosis (DCTD), part of the National Cancer Institute (NCI), governed by the National Institutes of Health (NIH) in the USA] or NCIC (National Institutes of Health Canada) for use in clinical research trials must be managed in a way to ensure compliance with the regulations outlined by CTEP and Division 5 of the Health Canada Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects).This policy details procedures for the ordering, receipt, storage, dispensation and return or destruction of investigational agents.