One of the major goals of the new clinical trials framework is to construct an informatics system that will reduce the extensive paperwork often associated with clinical trials. Electronic data systems now make it easier for clinical researchers to record and report data and adverse events.

Common Toxicity Criteria (CTC)

The CTC is a standard language for reporting adverse events occurring in cancer clinical trials. Developed in 1984, the CTC was revised in 1998 to improve the comprehensiveness and accuracy of reporting and to standardize reporting across the Cooperative Groups and therapeutic modalities. CTC Version 2.0 was initially implemented for NCI treatment trials begun on and after March 5, 1998. It has been adopted by other organizations, including the EORTC and pharmaceutical companies. It includes:

• Mapping of adverse event names to preferred terms in MedDRA (Medical Dictionary for Drug Regulatory Reporting), the standard language for drug regulatory reporting globally.
• A Web-based interactive application for identifying and grading events electronically, creating reports, and saving them in local databases.
• An index with cross references to other medical and lay terms.
• Mapping of the original CTC to version 2.0.
• A user's manual and a Web-based tutorial.

Adverse Event Expedited Reporting System (AdEERs)

AdEERS is a Web-based system designed to allow Cooperative Groups, Cancer Centers, and single institutions to submit expedited reports for serious and/or unexpected events to the NCI for all trials using an NCI-sponsored investigational agent. AdEERS is integrated with existing CTEP applications, including the CDUS and the CTC, to promote data reuse. It includes:

• Lists of values for adverse event terms, disease names, prior therapies, and pre-existing conditions, mapped to MedDRA (Medical Dictionary for Drug Regulatory Reporting), the standard language for drug regulatory reporting globally.
• Links to the NCI guidelines for reporting adverse events and the Agent Specific Adverse Event List.
• Interactive Computer Based Training (CBT) designed to assist users in the completion of an actual report, with simultaneous access to the CBT and AdEERS.

Clinical Data Update System (CDUS)

The CDUS is the primary data reporting mechanism for all NCI-sponsored clinical trials. It was developed with the goals of standardizing and streamlining data reporting and reducing the administrative burden of cancer research. Benefits include:

• Elimination of duplicate reporting mechanisms and other annual reports required by the NCI.
• Integration with other NCI databases, reducing investigators' data entry burden.
• Revision and validation of NCI and Group databases (e.g., protocol numbers and status).
• Immediate and automated error checking.
• Rapid transactions allowing investigators to find source data and make corrections before the data matures.

Common Data Elements (CDE)

CDEs are terms that medical providers may use to collect and report patient information for clinical trials. The purpose of the CDE Dictionary is to promote a common nomenclature and vocabulary across various organizations performing cancer research. This project is a continuing collaborative effort between the NCI and partners who represent a variety of clinical and basic science disciplines. At present, the CDE Dictionary:

• Includes an extensive listing of data elements that could be required by a cancer treatment trial for lung, breast, prostate, and colorectal cancers.
• Contains a repository of detailed information pertaining to each standard element for clinical trial data collection.
• Offers templates of case report forms that can be used to create forms that are specific to a protocol.
• Evolves as new terms for additional cancers are identified and defined.

Back to Top

< Previous Section  |  Next Section >