ROLES OF THE SPONSOR - UKM Medical Centre

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G C P What are the roles Sponsor’s Role ◦ Section 5.1 – 5.23 of ICH GCP guidelines Ethical & scientific quality standard for the design, conduct, recording & reporting of trials that involve human subjects. CRC GCP Workshop 2012 H<strong>UKM</strong>
G C P 1.Designing the trial • Utilize qualified individuals ( biostatisticians, clinical pharmacologist, Study physicians) - design protocol - design Case Report Form - plan the analysis - analyze data & - prepare clinical trial reports. Scientific Integrity of trial, credibility of data CRC GCP Workshop 2012 H<strong>UKM</strong>
Page 1 and 2: G CP ROLE OF THE SPONSOR ADELINE KW
Page 3: G C P Who is the sponsor • An in
Page 7 and 8: G C P 2. Delegate Medical Expertise
Page 9 and 10: G C P 3. Manufacturing, Labelling,
Page 11 and 12: G C P Knowledge Check : Selection o
Page 13 and 14: G C P 6. Provide adequate informati
Page 15 and 16: G C P 7. Secure Agreements • Clin
Page 17 and 18: G C P Secure Agreements Financial A
Page 19 and 20: G C P 9. IRB/EC approval • Confir
Page 21 and 22: Sponsor Responsibilities : 11. Qual
Page 23 and 24: G C P 13. Ongoing safety evaluation
Page 25 and 26: G C P Manage the Data Trial data (p
Page 27 and 28: G C P Data Management • Quality C
Page 29 and 30: G C P Records and Reports • Retai
Page 31 and 32: G C P 17. Monitor compliance • Co
Page 33 and 34: G C P 19. Contract Research Organiz
Page 35 and 36: Questions

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