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Clinical Trial Monitoring: Ensuring Compliance and Data Integrity

Learn about the importance of overseeing and ensuring clinical trials are conducted according to protocols, GCP, and regulatory requirements. Discover the roles, responsibilities, and differences between monitoring, auditing, and inspection. Welcome to presentations and discussions.

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Clinical Trial Monitoring: Ensuring Compliance and Data Integrity

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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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