GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia

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<strong>GCP</strong> : Practical Issues 2 6. Non-investigator health care provider Change therapy Communication & Understanding Role of the subjects, Identification Card 7. Reporting of AE/SAE/Protocol Violation & Deviation Time frame, Sponsor & IRB 8. Data Queries (DNF) Too many queries generated Participation of Sponsor’s CRA 9. Sponsor & Regulatory Body Audits 10.Intellectual Property & Publication Agreement 11.Too Many Clinical Drug Trials Competing Studies
During the 1990’s, the deaths of two healthy volunteers in the US made their way to the highest political levels and forced a review of human subjects protections Jesse Gelsinger 18 year old Healthy Volunteer Genetic Study Ellen Roche 24 year old Healthy Volunteer Asthma study
Page 1 and 2: Good Clinical Practice (GCP) Worksh
Page 3 and 4: GCP adoption in the Asia Pacific Re
Page 5 and 6: ”Great Complicated Paperwork”
Page 7 and 8: Complaints about GCP Compliance 1 1
Page 9 and 10: Factors that hinder the proper impl
Page 11: GCP : Practical Issues 1 1. Delay i
Page 15: Issues in GCP Implementation Unders
Page 18 and 19: Malaysian GCP Guideline 2004 5.20.3
Page 21 and 22: Mitchell Creinin from Pittsburgh: T
Page 23 and 24: Alkis Togias of John Hopkins: Clini
Page 25 and 26: What the FDA Typically Finds 100 90
Page 27 and 28: Clinical Investigator Deficiency Ca
Page 29 and 30: Sponsor/Monitor/CRO Inspections Com
Page 31 and 32: Other Issues 2 EC Approval Signatur
Page 33 and 34: Good Clinical Practice (GCP) A stan
Page 35 and 36: If you want to be an investigator
Page 37 and 38: Commitments S _______ upervise M __
Page 39 and 40: Patients vs Subjects When a person
Page 41 and 42: Can’t my Study Coordinator handle
Page 43 and 44: Making Corrections on study records
Page 45 and 46: Who can obtain informed consent Inf
Page 47 and 48: 1. Informed Consent During an audit
Page 49: 3. Informed Consent During an audit
Page 52 and 53: How to conduct clinical trials in M
Page 54 and 55: Application submission 5 copies Sec
Page 56 and 57: GCP is not a wallpaper you paste ov
Page 58 and 59: Do not differentiate your everyday

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