Transcription of 【重要ポイント】 - jpma.or.jp
1 12 19 25 PMDA 6 19 2007 38 25 (2013 ) 169 PMDA 26 GCP 3. I 26 10 27 #page=13 (MRCT:Multi Regional Clinical Trial) ICH-GCP GCP ICH GCP / 4 ICH ICH / /EU 3 ICH ICH 2 3 1 ICH Quality( ) Safety( ) Efficacy( ) Multidisclinary( )
2 [ ] MHLW PMDA JPMA [ ] FDA PhRMA [EU] EU EMA EFPIA [ICH ] IFPMA [ ] WHO Health Canada FTA 2015 3 ICH EU 2015 ICH 2016 ICH ICH ICH ICH GCP ICH-GCP GCP GCP GCP 28 36 14 14 106 172 72 24 163
3 68 161 PMDA ICH-GCP J-GCP ICH-GCP J-GCP ICH-GCP J-GCP SMO ICH-GCP SMO SMO 7 IRB IRB IRB IRB EU EU EU Clinical Trial Directive 1 1 Code of Federal Regulations Joint or cooperative review 20 3 GCP IRB IRB IRB 8 ICH GCP J-GCP J-GCP 24 5 9 /
4 FCPA 1977 EU 25 2014 5 EU Regulation 15 EU SAE 24 ICH-GCP PhaRMA FAQ GCP PMDA GCP FDA IND IND IND 2014 11 EU EU DIRECTIVE MHRA GCP 2 EU DIRECTIVE Clinical Trial Regulation 2016 5 12 / / J-GCP Delegation list CV(Curriculum Vitae)
5 Delegation lis Financial Disclosure 2011 5 ICH-GCP,Information Sheet Guidanc e for IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators, IV. How are clinical investigator inspections conducted? ,Code of Federal Regulations 21 CFR,Form FDA 1572 ,PhARMA FAQ US 119 2005-02 2008-35 2010-26 2010-58 EDC 2011-27 2011-28 2012-48 2012-43 13 PhaRMA FAQ Financial Disclosure PhaRMA FAQ Form 1572 Form 1572 Training Log Site Initiation Visit Report ( SIV Report )
6 16 Confirmation Letter CRA On-site Relevant Communications Other Than Site Visit Fax Follow-up Letter Follow-up Letter Investigational Product Temperature Log 17 / 5 18
7 IRB CRF 2 Win-Win
8 212223 ALCOA ALCOA Best Documentation Practice PMDA ALCOA 24 Signature Delegation list Role & Responsibility AE EDC IRB / Signature Signature Log 2526272829
