Transcript Preparation For A Monitoring Visit - presentation

PREPARATION FOR A
MONITORING VISIT
KEMRI-Wellcome Trust Research Programme
Version: 4-Nov-2008
Before the visit
• What is the objective of the visit? Site
qualification/assessment, routine interim visits,
pre-audit/inspection, close out?
• Contact the investigator & coordinator and
arrange a mutually suitable time.
• Good to have an agenda of check in visit,
discuss if there any issues to be addressed.
• What you need: Monitoring SOP, previous
report, book to draft issues on and sticky notes!
KEMRI-Wellcome Trust Research Programme
Version: 4-Nov-2008
Documents to pre-review
1. Protocol:
– understand objectives
– eligibility criteria e.g. fever of > 37.5, weight 15-25kg
etc
– procedures e.g. calculation of parasite density,
outcome assessments especially endpoints e.g.
recurrence of malaria positive slide after treatment
– safety reporting; timelines, who receives reports
– Sample handling e.g. exportation, storage
requirements
KEMRI-Wellcome Trust Research Programme
Version: 4-Nov-2008
Documents to pre-review
2. SOPs/MOPs – usually not availed prior visit if
you are an external monitor

As an internal monitor good to review them prior to
visit to understand trial better

Which SOPs? IC, screening, enrolment
randomization, safety reporting, drug handling, key
procedural SOPs.
KEMRI-Wellcome Trust Research Programme
Version: 4-Nov-2008
Documents to pre-review
3. Previous monitoring report(s)
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General feel of the study quality(!)
Outstanding issues
Areas of need; previously monitored ones or not
monitored areas
New ideas
KEMRI-Wellcome Trust Research Programme
Version: 4-Nov-2008