Transcription of NCI GUIDELINES FOR INVESTIGATORS
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NCI GUIDELINES FOR INVESTIGATORS
NCI GUIDELINES FOR INVESTIGATORS : ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) AND DCP INDs AND IDEs Effective September 16, 2013 AdEERS Medical Help Desk Contact Information: Phone: Fax: E-mail: NCI GUIDELINES : Adverse Event Reporting Requirements February 29, 2012 Page 2 Table of Contents 1 Introduction .. 3 Scope .. 3 Purpose .. 3 Investigator Responsibility .. 3 Sponsor Responsibility .. 4 2 Tools for AE Reporting .. 5 Basic Terminology .. 5 CTCAE .. 10 CAEPR .. 10 HIPAA .. 11 3 Routine AE Reporting to NCI: Scope .. 12 CDUS .. 12 CTMS.
an Investigational New Drug application (IND)/Investigational Device Exemption (IDE) sponsor and/or a funding sponsor and are responsible for ensuring that the research is conducted in accordance with Federal regulations. The guidance provided herein, for all DCTD-sponsored studies that fall under an FDA
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