carcinoGENOMICS.eu: Questionnaire
http://www.carcinogenomics.eu/index.php?id=110

carcinoGENOMICS - a project of the European Union

Questionnaire

This questionnaire addresses various aspects of the regulatory acceptance process and is send to representatives of regulatory bodies, industry and academia. The Information obtained will be used in the carcinoGENOMICS project to give guidance to the conditions newly developed methods have to meet for improving regulatory acceptance.

This questionnaire includes two parts; a) a guidance document for researchers specifying the aspects that should be covered for submission of new test methods to regulatory agencies; b) the questionnaire with questions about validity specifications for new test methods and data sets required for regulatory decision making. The guidance document is presented here in a draft version. Additional input from regulators and toxicologists will be welcomed for further improvement.

Adobe PDFPDF: Offline version of the carcinoGENOMICS Questionnaire (2.3 MB)

Adobe PDFPDF: Intro carcinoGENOMICS questionnaire and guidance document (908 kb)

Adobe PDFPDF: Guidance document for test method submission (540 kb)

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