Brochure GCP 2020(1) - final
Transcript of Brochure GCP 2020(1) - final
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Day 1 Day 2
Day 3
Clinical Research in MalaysiaOverview of ICH/GCPICH GCP / Malaysian GCP comparedOverview of Ethics of ClinicalResearch, Ethical Principles &RequirementsIndependant Ethics CommitteeEthical Problems in ClinicalResearchClinical Trial Protocol &Investigator's BrochureInformed Consent
Investigator's Responsibility* Group workSponsor's ResponsibilityAdverse Events* Group work
GCP Inspection & Regulatory Aspects of Clinical Trial in MalaysiaGCP Examination
Good Clinical Practice (GCP) is a set of rules & regulations provided by ICH; an international body that regulates clinical trials involving human subjects. It is standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data & reported results are credible & accurate, as well as the rights, integrity and confidentiality of trial subjects are protected.
WorkshopGOOD CLINICAL PRACTICE (GCP)
2020
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