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MONITORING

MONITORING. Gilbert Ogetii KEMRI-Wellcome Trust Research Programme Kilifi, Kenya. WELCOME!. Presentations Outline: Topics – as in time table Short presentations Q and A - discussions. Definition.

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MONITORING

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  1. MONITORING Gilbert Ogetii KEMRI-Wellcome Trust Research ProgrammeKilifi, Kenya

  2. WELCOME! Presentations Outline: • Topics – as in time table • Short presentations • Q and A - discussions Version: 4-Nov-2009

  3. Definition “the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, Good Clinical Practice (GCP), and the applicable regulatory requirements” (ICH-GCP E6 ) Version: 4-Nov-2009

  4. 3 main purposes • The rights and well-being of the trial subjects are protected • Trial data is accurate, complete and verifiable • Trial conduct complies with the approved protocol, with GCP and with all regulatory approvals Version: 4-Nov-2009

  5. Whose responsibility? • The sponsor • Sponsor appoints monitors • Monitors should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. Version: 4-Nov-2009

  6. Internal monitoring • As a QC measure to ensure studies meet GCP standards •  number of investigator led studies – no sponsor arranged monitoring • Augments External monitoring incase of sponsor led trials Version: 4-Nov-2009

  7. What is the difference between these three? • Monitoring • Auditing • Inspection Version: 4-Nov-2009

  8. Questions? Version: 4-Nov-2009

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