Canadian Cancer Trials Group Bulletins

Ethics Regulatory

Updated CTEP Adverse Event Guidelines

Effective July 26, 2011, the Cancer Therapy Evaluation Program (CTEP) and the Cancer Imaging Program (CIP) under the Division of Cancer Treatment and Diagnosis (DCTD) and the Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) has updated and posted their document titled, NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) AND DCP INDs AND IDEs. Please note, significant revisions have been made to section 5.5. This document can be found at:$.startup

The expectations for reporting serious adverse events are outlined within each protocol (or Canadian appendix for Intergroup trials). NCI US-affiliated trials use the Adverse Event Expedited Reporting System (AdEERS). The primary purpose of this document is to provide guidelines for adverse event (AE) reporting to NCI for agents provided under a CTEP, DCP, or CIP Investigational New Drug application / Investigational Device Exemption (IND/IDE) and to ensure that sufficient AE event information is submitted by the site to allow for an independent assessment by CTEP, DCP, and CIP as IND/IDE sponsors. In addition, this document explains the expanded use of AdEERS for expedited AE reporting and describes new expedited reporting requirements for new CTEP and CIP INDs/IDEs studies, as well as CIP non-IND/IDE studies.