Monitoring

If the study protocol will be used for an IND or NDA whether sponsored by industry or investigator initiated either independent or industry sponsored monitors/auditors must review study data/compliance/and regulatory documents.  Assistance in how to handle monitoring visits can be found at: http://louisville.edu/research/clinicaltrials/investigators/Guidelines%20for%20SOP.pdf/view.  Your department/division/ research coordinators can assist.  Investigators and research team members who have experienced monitoring/auditing visits can be found through the Clinical and Translation Sciences Institute (http://louisville.edu/ctsi). Sponsors routinely hire auditing firms to audit data from high recruiting sites.  If you have questions about auditing visits use the assistance tools noted above.