Discussion of points to consider in creating nSDRG of SEND datasets -3-

DOI
  • NAKAZAWA Chihiro
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam Eisai Co., Ltd.
  • IMAWAKA Miho
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam Axcelead Drug Discovery Partners Inc.
  • KATOKU Koshiro
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam LSIM Safety Institute Corporation
  • KANEKO Yoshifumi
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam KYORIN Pharmaceutical Co., Ltd.
  • SAKAKIBARA Yuta
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam Kyowa Kirin Co., Ltd
  • HAMADA Atsushi
    CDISC Japan User Group (CJUG) SEND team, nSDRG subteam Japan Tobacco Inc.

Bibliographic Information

Other Title
  • SENDデータセットのnSDRG作成における課題とその対処法の検討 -3-

Abstract

<p>nSDRG is a document for reviewers to understand the outline of SEND dataset. Although the guideline and template published by PHUSE are useful for creating nSDRG, it is challenging to understand the level of detail necessary, and the original information may not be sufficient to create a proper nSDRG. The nSDRG subteam of CJUG SEND team extracted the actual issues when facing the creation of nSDRG and shared them with PHUSE nSDRG working group for the discussion on resolving these issues, as reported at the last 2 JSOT meetings.</p><p>In this poster session, we report the topics that have been discussed with PHUSE and those picked-up by PHUSE for preparing the next version of guideline and template considering the issues we shared. </p>

Journal

Details 詳細情報について

Report a problem

Back to top