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