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Common Terminology Criteria for Adverse Events Project


The Common Terminology Criteria for Adverse Events (CTCAE) is an NCI terminology that is used for reporting adverse events that occur during NCI sponsored clinical trials. The CTCAE Version 3.0 terminology is a dictionary of adverse events and grading criteria for all modalities used in the treatment of cancer.

The caBIG™ Vocabularies and Common Data Elements (VCDE) Workspace and NCI Cancer Therapy Evaluation Program (CTEP) are conducting a project to revise the CTCAE terminology. A Steering Committee and Advisory Board have been established to address governance, computer support and project management issues.

The goals of the CTCAE 3.0 revision project are to:

  • Harmonize CTCAE with MedDRA (Medical Dictionary for Regulatory Activities)
  • Revise and extend CTCAE adverse events and severity indicators in the terminology
  • Make the terminology machine interpretable and compliant with caBIG Vocabulary Criteria
  • Establish formal, ongoing governance for future maintenance of CTCAE
  • Have CTCAE better meet the needs of clinical investigators
The project is scheduled to run through the first quarter of 2009.


Who should get involved?


The revision of CTCAE Version 3.0 will be performed by members of 12 working groups each addressing adverse events falling under one or more of MedDRA's System Organ Classes. The VCDE Workspace is seeking clinician subject matter experts to join the CTCAE project working groups. The working groups will be small, collaborative, and will ideally contain representation of the clinical trialist and clinical research reporting points of view. Please contact the project manager, Ranjana Srivastava to become a Working Group member or if you have any other questions.


Contact Information


Ranjana Srivastava: srivastava_ranjana@bah.com

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last modified 07-21-2008 11:46 AM