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Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs
The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization and standardization of nonclinical study data; thus, related organizations have begun implementing processes in support of SEND. The Global Editorial...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Japanese Society of Toxicologic Pathology
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6511540/ https://www.ncbi.nlm.nih.gov/pubmed/31092979 http://dx.doi.org/10.1293/tox.2018-0066 |
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author | Anzai, Takayuki Matsuyama, Takaaki Wasko, Michael Hatakeyama, Hirofumi Horikawa, Shin-ichi Anzai, Reo Iwata, Hijiri Imai, Norio Mizuhashi, Fukutaro Tsuboi, Masaru Okuzono, Takeshi Takagi, Hisayoshi Cho, Hyeon Rong, Bryan Tan Siang Masaki, Fumio Nakae, Dai |
author_facet | Anzai, Takayuki Matsuyama, Takaaki Wasko, Michael Hatakeyama, Hirofumi Horikawa, Shin-ichi Anzai, Reo Iwata, Hijiri Imai, Norio Mizuhashi, Fukutaro Tsuboi, Masaru Okuzono, Takeshi Takagi, Hisayoshi Cho, Hyeon Rong, Bryan Tan Siang Masaki, Fumio Nakae, Dai |
author_sort | Anzai, Takayuki |
collection | PubMed |
description | The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization and standardization of nonclinical study data; thus, related organizations have begun implementing processes in support of SEND. The Global Editorial and Steering Committee (GESC), which provides oversight of the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), has prepared the SEND Controlled Terminology (CT) for toxicologic pathology. SEND provides electronic data standards created by the Clinical Data Interchange Standards Consortium (CDISC), and CDISC also collaborates in the implementation of SEND. Furthermore, the Pharmaceutical Users Software Exchange (PhUSE), which includes members of the US FDA, has conducted various activities to promote realistic and effective methods to implement SEND. As we reported in 2015, there is a significant variation in the efficiency and quality of SEND data implementation across pharmaceutical companies and contractors (CROs) globally. To address this problem, the Global SEND Alliance (G-SEND) was established in August 2018 to facilitate the coordination and standardization of SEND datasets across CROs in Asia. This paper reports the first method for organizationally and jointly creating consistent SEND datasets between CROs using G-SEND. |
format | Online Article Text |
id | pubmed-6511540 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Japanese Society of Toxicologic Pathology |
record_format | MEDLINE/PubMed |
spelling | pubmed-65115402019-05-15 Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs Anzai, Takayuki Matsuyama, Takaaki Wasko, Michael Hatakeyama, Hirofumi Horikawa, Shin-ichi Anzai, Reo Iwata, Hijiri Imai, Norio Mizuhashi, Fukutaro Tsuboi, Masaru Okuzono, Takeshi Takagi, Hisayoshi Cho, Hyeon Rong, Bryan Tan Siang Masaki, Fumio Nakae, Dai J Toxicol Pathol Letter The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization and standardization of nonclinical study data; thus, related organizations have begun implementing processes in support of SEND. The Global Editorial and Steering Committee (GESC), which provides oversight of the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), has prepared the SEND Controlled Terminology (CT) for toxicologic pathology. SEND provides electronic data standards created by the Clinical Data Interchange Standards Consortium (CDISC), and CDISC also collaborates in the implementation of SEND. Furthermore, the Pharmaceutical Users Software Exchange (PhUSE), which includes members of the US FDA, has conducted various activities to promote realistic and effective methods to implement SEND. As we reported in 2015, there is a significant variation in the efficiency and quality of SEND data implementation across pharmaceutical companies and contractors (CROs) globally. To address this problem, the Global SEND Alliance (G-SEND) was established in August 2018 to facilitate the coordination and standardization of SEND datasets across CROs in Asia. This paper reports the first method for organizationally and jointly creating consistent SEND datasets between CROs using G-SEND. Japanese Society of Toxicologic Pathology 2019-03-02 2019-04 /pmc/articles/PMC6511540/ /pubmed/31092979 http://dx.doi.org/10.1293/tox.2018-0066 Text en ©2019 The Japanese Society of Toxicologic Pathology This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License. (CC-BY-NC-ND 4.0: https://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Letter Anzai, Takayuki Matsuyama, Takaaki Wasko, Michael Hatakeyama, Hirofumi Horikawa, Shin-ichi Anzai, Reo Iwata, Hijiri Imai, Norio Mizuhashi, Fukutaro Tsuboi, Masaru Okuzono, Takeshi Takagi, Hisayoshi Cho, Hyeon Rong, Bryan Tan Siang Masaki, Fumio Nakae, Dai Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs |
title | Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient
creation of electronic SEND datasets between CROs |
title_full | Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient
creation of electronic SEND datasets between CROs |
title_fullStr | Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient
creation of electronic SEND datasets between CROs |
title_full_unstemmed | Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient
creation of electronic SEND datasets between CROs |
title_short | Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient
creation of electronic SEND datasets between CROs |
title_sort | establishment of the global send alliance (g-send) in japan and efficient
creation of electronic send datasets between cros |
topic | Letter |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6511540/ https://www.ncbi.nlm.nih.gov/pubmed/31092979 http://dx.doi.org/10.1293/tox.2018-0066 |
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