The second edition of 'Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance' explores the current environment and new challenges in the development, validation, and use of computerised systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.
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Consortium committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of non-clinical data.
Standard for exchange of non-clinical data
Study data specifications
A revised version of the SEND standard, SEND 3.0, is due for publication by CDISC during June 2011.
This version of the standard has been designed to accommodate the exchange of protocol, subject, inlife and pathology findings data for the most common general toxicology study protocols including pharmacokinetic data. The standard itself is built on the Study Data Tabulation Model (SDTM) standard already in widespread use by the Clinical community. Whilst sticking to the principles of the SDTM, SEND has modified the relevant definitions to make them applicable to toxicology studies, extending the range of data that can be handled and modifying aspects of the protocol structures as necessary. Harmonization of the clinical and preclinical standards has been an important goal of the project in order to facilitate later analysis across disciplines.
In addition to the data definitions, SEND has also established an extensive set of Controlled Terminology that is to be used in conjunction with the standard. These standardised sets of terminology cover areas such as units of measure, body system and species. Some of the lists are extensible, while others are fixed.
The SEND standard is described in a document called the SEND Implementation Guide. This comprehensive (250+ pages) document describes, with many examples, all aspects of the standard including the 27 different types of dataset covered by this version. These datasets will be created as SAS transport files in the initial implementation.
This version of the standard is expected to be formally adopted by the FDA for the submission of regulatory data to the agency and announcements regarding this are expected later in 2011. The FDA has been intimately involved in the development of the standard, working with a group of industry organisations (sponsors, CRO’s and software vendors) under the auspices of CDISC. The members of this syndicate have created and submitted many test datasets to the FDA as part of the standard’s development, testing both the data structures themselves as well as the FDA’s gateway technology and their review and analysis tools.
Work is already underway to extend the standard to include Safety Pharmacology and Reproductive Toxicology study types. The timelines for these extensions are not yet finalised and there is ample opportunity for interested parties to get involved in helping to shape these new areas. Contact CDISC (www.cdisc.org) for further information.