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NTIS 바로가기The journal of KAIRB = 대한기관윤리심의기구협의회지, v.3 no.1, 2021년, pp.1 - 10
이찬주 (가톨릭대학교 생명대학원 임상연구윤리학과) , 최병인 (가톨릭대학교 생명대학원 임상연구윤리학과)
In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a lar...
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Dan S, Bosea A, Ghosh B, Mandalc P, Pal TK. New Drugs and Clinical Trials Rules-2018 (GSR-104 E) by CDSCO: It's Impact on BA/BE Studies in India. Pharmaceut Reg Aairs 2018;7:1000208.
Ministry of Food and Drug Safety. ICH Korean version of Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2017 [cited 2020 Oct 23]. Available from https://www.nifds.go.kr/brd/m_105/view.do?seq30603&srchFr&srchTo&srchWord&srchTp&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&page9. Accessed 2020 October 23.
Urooj M, Husain GM, Khan MA, Kazmi MH. Compensation to clinical trial participantsin India: a gap analysis. Int J Pharm Investig 2017;7:41-6.
Mallath MK, Chawla T. Investigators' viewpoint of clinical trialsin India: past, present and future. Perspect Clin Res 2017;8:31-6.
Chingarande GR, Moodley K. Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa. BMC Med Ethics 2018;19:8.
Ravi A. Over 24,000 clinical trial deaths and SAEs in India in ten years [Internet]. The Sunday Guardian Live; 2017 November 5 [cited 2020 Oct 13]. Available from: https://www.sundayguardianlive.com/news/11550-over-24000-clinical-trial-deaths-and-saes-india-tenyears.
National monitoring: illiterate population [Internet]. UNESCO Institute for Statistic; [cited 2020 Dec 24]. Available from: http://data.uis.unesco.org/#.
India releases new draft rulesreinforcing compensation requirements for injuries 'related to' clinical trials [Internet]. Bloomberg Law. Pharmaceutical & Life Sciences News; 2018 [cited 2020 Sep 16]. Available from: https://news.bloomberglaw.com/pharma-and-lifesciences/india-releases-new-draft-rules-reinforcing-compensation-requirements-for-injuries-related-to-clinical-trials.
Extraordinary, Part II- Sec3(i), CHAPTER VI COMPENSATION. Gazette India 2019;161-4, 234-6. Available from https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf. Accessed 2020 Sep 25.
A guide to minimum wage in India [Internet]. India Briefing News. 2020 [cited 2020 Dec 24]. Available from: https://www.india-brieng.com/news/guide-minimum-wage-india-2021-19406.html/.
National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR Guidelines). New Delhi, India: Indian Council of Medical Research; 2017. p. 8-10.
Bioethics and safety act (Eective date 2020 Sep 12) [Internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsInfoP.do?efYd20200912&lsiSeq220891#0000.
Pharmaceutical affairs act (Effective date 2020 Oct 08) [internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsSc.do?section&menuId1&subMenuId15&tabMenuId81&eventGubun060101&query%EC%95%BD%EC%82%AC%EB%B2%95#undened.
Rules on the drug safety [Attachment 4] Good Clinical Practice of Drug (Effective date 2020 Oct 14) [Internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsBylInfoP.do?bylSeq10297391&lsiSeq220711&efYd.
Guideline for preparing protocols and procedures for compensation of clinical trial subjects (Complainant's Guide) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2019 [cited 2020 Feb 3]. Available from: https://www.mfds.go.kr/brd/m_210/view.do?seq14416.
Gross national income per capital [Internet]. Daejeon (Korea): Korean Statistical Information Service; 2020 [cited 2020 Oct 28]. Available from: https://kosis.kr/statHtml/statHtml.do?orgId101&tblIdDT_2AS017&conn_pathI2.
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