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Adverse Events Terminology Standards, Data Elements and Case Report Forms
15 Mar 2014 | Contributor(s): Sherri de Coronado, Ann Christine Catlin, Sumudinie fernando, Denise Warzel
Standards for coding, naming and grading adverse events (AEs) in cancer clinical trials include both cancer-focused and broader systems that all result from collaboration among academic, governmental, and pharmaceutical industry clinical investigators. They are all based on the need for...
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NCI Standard CRFs
15 Mar 2014 | Teaching Materials | Contributor(s): Denise Warzel, Ann Christine Catlin, Sumudinie fernando
Working in conjunction with NCI has developed a collection of Standard Case Report Forms (CRFs) for use in developing new protocols. The project and its status are described here. The reuse of sections from standard CRFs helps to ensure that data collected in different studies is compatible and...
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Why Use the Standards Portal at the Hub?
19 Mar 2014 | Teaching Materials | Contributor(s): Denise Warzel, Sumudinie fernando, Ann Christine Catlin
The materials attached to this page were provided by Baris Suzek, who at the time was the Informatics Project Lead at the Innovation Center for Biomedical Informatics at Georgetown University School of Medicine. He conducted a study for the caBIG VCDE community to help clarify some of the...
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TCGA Common Data Elements
15 Mar 2014 | Teaching Materials | Contributor(s): Ann Christine Catlin, Sumudinie fernando, Denise Warzel
TCGA Common Data ElementsTCGA version 2.6 CDEs are the standard elements that were used in validation of clinical data in the TCGA 2.6 data files. The data files are available for download at the Data Matrix. This resource page at the NCIP HUB presents the CDEs for easy search and discovery....
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Performance Status Scoring : a standards portal resource
15 Mar 2014 | Teaching Materials | Contributor(s): Ann Christine Catlin, Sumudinie fernando, Denise Warzel, Angela Kummerow
The scoring scale used may depend on patient population, disease, study goals and other criteria. Many definitions of the scale scoring do not match the standard.What is Performance Status?Performance status attempts to quantify the general well-being of cancer and other patients. The score...