PREPARATION FOR A MONITORING VISIT

KEMRI-Wellcome Trust Research ProgrammeVersion: 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-review1. 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)

– 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