ICH guidelines for Biostatisticians in Industry

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製薬企業統 計担当者のためのICHガイドライン集

Since 18 Nov 2001
(New site: since 3 Aug 2003)
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Last Update: 21-August-2012




Electronic Clinical Trial Link updated!  

  1. PhRMA "Electronic Clinical Data Capture Position Paper Revision 1" (2005/05/01)
    eclinicalforumサイトのReports, Presentations, Articles and Publications=>見付かりません
  2. PhRMA "The Future Vision of Electronic Health Records as eSource for Clinical Research" Version 1.0 (2006/9/14)
    eclinicalforumサイトのファイル=>見付かりません  Draft
  3. EMEA "Reflection Paper on Expectations for Electronic Source Documentsused in Clinical Trials" (Draft 2007/10/17)
  4. CDISC eSDI group "Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials" (v1.0 2006/11/20)
    CDISC eSource Data Interchange Document
  5. FDA "Guidance for Industry: Computerized Systems Used in Clinical Investigations" (2007/05)
  6. FDA "Guidance for Industry on Part 11, Electronic Records; ElectronicSignatures--Scope and Application" (2003/08)
  7. FDA "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (2002/01/11)
  8. 「医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について」(薬食 発第0401022号2005/04/01)
    パブリックコメン ト結果
  9. 医療情報システムの安全管理に関するガイドライン第4.1版(2010/02)
    http://www.mhlw.go.jp/shingi/2010/02/s0202-4.html
     
  10. EU "GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP”ENVIRONMENTS" (PIC/S Guidance PI 011-3 2007/09/25)
    http://www.picscheme.org/publication.php?id=8
  11. EU PIC/S GMP GUIDE (ANNEXES) ANNEX 11:COMPUTERISED SYSTEMS (PI 009-9 2009/09/01)
    http://www.picscheme.org/publication.php?id=4
  12. SCDM "Good Clinical Data Management Practices" (GCDMP) (Japanese translation is available!)
    https://www.scdm.org/gcdmp/  <= Membership or fee required to download   New! 日本語版購入リンク
  13. 製薬協EDC自主ガイダンスおよび説明会資料
    http://www.jpma.or.jp/about/basis/guide/clinical.html


Anticancer drug development related links 

NCI
  1. Response Evaluation Criteria in Solid Tumors (RECIST)
    固形がんの治療効果判定のための新ガイドライン(RECIST ガイドライン)―日本語訳JCOG版―
  2. CTC v2.0 and Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
    NCI-CTC 日本語訳本文 インデックス (JCOG)
    CTCAEv3.0日本語訳JCOG/JSCO版
Japan
  1. 抗悪性腫瘍薬の臨床評価方法に関するガイドライン 改訂版(2005/11)  通知  本文
  2. 抗悪性腫瘍薬の臨床評価方法に関するガイドライン Q&A(2006/3)
  3. パ ブリックコメント結果(ZIP)
FDA
  1. Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics(2007/05)
    Japanese Translation :  http://jsmo.umin.jp/oshirase/20071005.html
  2. Guidance for Industry Cancer Drug and Biological Products - Clinical Data in Marketing Applications (2001/11)
  3. Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (1998/12) 
EMEA
  1. Guideline on the Evaluation of Anticancer Medicinal Products in Man (CHMP/EWP/205/95 REV. 3) (2005/12) 
  2. Guideline on the Evaluation of Anticancer Medicinal Products in Man - Methodological Considerations for Using Progression-Free Survival (PFS) as Primary endpoints in confirmatory trials for registration Human (2008/01) 
  3. Others:  See "Antineoplastic and immunomodulating agents " of Scientific Guidelines for Human Medicinal Products http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm
Organizations




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Original files of ICH guidelines were obtained from Regulatory Authority sites and are edited.
Source guidance documents are provided by Regulatory Authority mainly as PDF format..
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This page is maintained by Akihiro Kobayashi. If there are mismatches with original ICH guidelines, they due to the editor's mistake. If you find any mistakes, please notify by email.