Brochure GCP 2020(1) - final

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Transcript of Brochure GCP 2020(1) - final

gcpkualalumpur@gmail.com 03-2698 0310

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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

https://bit.ly/2FVm8qz