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PREPARATION FOR A MONITORING VISIT

PREPARATION FOR A MONITORING VISIT. 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.

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PREPARATION FOR A MONITORING VISIT

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  1. PREPARATION FOR A MONITORING VISIT KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  2. 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

  3. Documents to pre-review • 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

  4. Documents to pre-review • 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

  5. Documents to pre-review • Previous monitoring report(s) • 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

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