5．SEND Datasets for Regulatory Requirements and Beyond

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　The story of the Standard for Exchange of Nonclinical Data (SEND) began in the late 20^th century, when industry guidances about electronic regulatory submissions were issued by the United States Food and Drug Administration (US FDA) and the International Conference on Harmonisation [(ICH), now recognized as the International Council for Harmonisation]. These documents and subsequent supporting guides contain details and specifications for electronic submissions, including settings for portable document format (PDF) documents and SAS Transport Files and the order for arranging the submission content ^1,2). In the early 2000s, electronic data capture systems were rudimentary when compared with the capabilities of today's software, and many data types were recorded on paper. The effort involved in preparing just the tumor.xpt, the pioneer for the SEND concept, was enormous ³⁾. The tools available at the time were not sophisticated enough to trace a palpable mass and its measurements noted during inlife to the observations recorded at necropsy and finally to correlate with the pathologist's findings and diagnoses. Now, over 20 years later, and with the introduction of multiple new guidances and guides, rule sets, official versions, and effective dates, the idea of data presented in a standardized format has moved from reluctant adoption to acceptance and even to expanded use beyond a regulatory submission.