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Common Toxicity Criteria v2.0 Tutorial

The CTC v2.0 Tutorial is designed to support health care professionals in the integration of CTC v2.0 into practice. The tutorial provides guidance in the organization of the CTC, defines adverse event grading, assignment of attribution, explains grading related toxicities, and outlines grading adverse events in special populations.

Background:

The National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) developed the original Common Toxicity Criteria in 1982 in an effort to provide standard language for reporting adverse events occurring in cancer clinical trials sponsored by the NCI. The CTC were widely adopted internationally and as new agents were introduced and new adverse events identified, many groups added supplemental criteria. This independent revision of the CTC resulted in nonstandard adverse event nomenclature and inconsistent definitions for severity. In keeping with international harmonization efforts, a CTC Review Committee with representation from the pharmaceutical industry, the Food and Drug Administration (FDA), the Committee for Proprietary Medicinal Products (CPMP), and major clinical trials groups in the US, Canada, Europe, and Japan was convened. The objective of the committee was to improve accuracy, precision and completeness of the CTC and to standardize reporting. As part of its commitment to the International Conference on Harmonization (ICH), the US FDA agreed to adopt an internationally agreed upon International Medical Terminology (IMT) based on the Medicines Control Agency's Medical Dictionary for Drug Regulatory Reporting (MedDRA) for use in reporting medical information from clinical trials. To facilitate data transfer, NCI has mapped adverse event names from the CTC version 2.0 to preferred terms in the IMT.

Your computer must meet the following requirements:

(To print these requirements and instructions , click your browsers print button or select file; Print from the menu bar.)

Item Requirement
Modem 33.6k bps or higher
Screen resolution* Set to 1024 X 768 pixels
Font size of your display* Set to Small Fonts
Color Palette* Set to High Color (16 bit)
Web browser Microsoft® Internet Explorer version 4.0 or later

OR

Netscape® Communicator version 4.0 or later
Processor Pentium
Monitor VGA display

* From the Control Panel, choose Display. Go to the Settings tab to change these settings.

To activate the new settings, restart the PC.

Before you begin:

1. Download a free copy of Neuron. Download Neuron by clicking Here

  • Choose to save the file to your desktop.
  • Then double-click the new file to execute the installation program.

This file will take approximately 30-50 minutes to download depending on the speed of your modem.

2. Start the CTC tutorial. Click to start tutorial

Notes:

  • A basic understanding of a Windows environment is required.
  • The navigational buttons on your browser will not allow you to navigate within the tutorial.You must use the navigational buttons provided within the tutorial.
  • To exit the tutorial, use the Exit  button provided within the CBT.Not exiting properly will cause errors.
  • To return to this page once you have exited the tutorial, use your browser's back button.
Inquiries specifically regarding theCommon Toxicity Criteria (CTC) or this tutorial should be addressed to: ncictephelp@ctep.nci.nih.gov

General Information: info@ctep.nci.nih.gov
Webmaster: webmaster@ctep.nci.nih.gov

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