Electronic case report tabulations

Current computerized analyses of adverse events still typically consist of a vast number of discrete, often personal, ad hoc processes that mimic paper and pencil methods. Some commercial-off-the-shelf (COTS) software tools (e.g., Adobe Acrobat , Microsoft Word , Excel ) do have the capability to search for specihc terms in electronic documents/case reports and do have navigational tools with hyperlinks and fullfull-text indexing that enable researchers to create their own hyperlinks. Some other COTS software tools (e.g., SAS , Excel , Access , IMP ) allow importation of electronic case report tabulations (ECRT) for more detailed analysis. 

Public Meeting on Clinical Data Interchange Standard Consortium Version 3 Submission Data Standards and Electronic Case Report Tabulations, October 2, 2003, Rockville, MD (Posted October 7, 2003)... 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

Archival Copy. This is a complete copy of the entire submission and serves as a reference for information not included in specific review copies and also as a repository for case report tabulations and case report forms. This copy is maintained on file at FDA after the review of the submission is completed. In accordance with recent guidances, certain sections (Sections 11 and 12) of a marketing application archival copy maybe submitted in electronic format. 

The electron affinities of the alkyl and cycloalkyl halides reported in the NIST tables are tabulated and evaluated in Appendix II. The NIST value is returned by a sequential search, using CX, CC1F, or CHX. In some cases two values that differ by more than the uncertainty have been reported so excited-state values can be assigned. Many of the Ea have only been measured by one technique thus, the experimental values could refer to an excited state. 

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