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Guidelines & Reports

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  • International
    • The Belmont report (1979) 
    • Clinical Safety Data Management : Definitions & Standards for  Expedited Reporting : ICH Harmonised Tripartite Guideline (1995)
    • Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (1995)
    • ICH guidelines (2005)
    • International Ethical Guidelines for Epidemiological Studies - CIOMS (2009)
    • Standards and Operational Guidance for Ethics review of Health related research with Human participants- WHO (2011)
    • Declaration of Helsinki (2013)
    • EFGCP Guidelines on Medical Research for and with Older People in Europe - (2013)
    • International Ethical Guidelines for Health-related Research Involving Humans - CIOMS (2016)

  • Local
    • Ethics Review Committee Guidelines – FERCSL – 2007
    • Guidelines for Ethics Review of Research Proposals Involving Animals in Sri Lanka – FERCSL – 2009
    • National Guidelines for the Establishment and Functioning of Ethical Review Committees in Health Care Institutions in Sri Lanka
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