1. PI oversight -what are the responsibilities -resources available for conducting the research (time, space, subject population, funding); medical care of trial subjects;
communications with the IRB/IEC; compliance with the protocol; investigational product accountability, use and storage; randomization procedures; informed consent of subjects; and trial records and reports. 2. Limited time for the visit...what would you cover. new enrollments, ICF, SAE, AE. 3. Unreported SAE...how would you handle...have the sight report at the visit the minimal requirements at least...patient#, drug, event description, reporter, source of info, study #/title, relatedness to study drug, also report event resolution and obtain discharge summary for pharmacovigilance; retrain site on reporting; have site report Prot viol to IRB, and CRA/team or site to report to Sponsor. 3. Typical monitoring visit and activities-before, during and after visit. 4. How to approach a difficult team member.
