Preparing for an Audit 8-09

CTEO TIP SHEET | Preparing for an AuditUpon receiving Notification of an Audit Confirm all appropriate study team members are notified about the audit including the researchpharmacy (if applicable) For an external Audit: Notify the Quality Assurance Office for Clinical Trials (QACT), Office forHuman Research Studies (OHRS), DFCI Research Pharmacy (and other participating institutionssresearch pharmacies), and Clinical Trials Offices for all external audits.research pharmacies), and Clinical Trials Offices for all external audits. Site study coordinators are responsible for reserving a space for the auditors at their location.Preparing for an Audit Review Regulatory Binder for completeness and accuracy Gather the requested information for each participant selected, this can include the following:Participant Entry and eligibility materials including informed consentPre-therapy, on-study, and follow-up requirement documentationTTrreeaattmmeenntt aaddmmiinniissttrraattiioonn aanndd ddoossee mmooddiiffiiccaattiioonnssToxicities and reporting of adverse eventsResponse assessmentsData Collection FormsDrug accountability Review information gathered for completeness and accuracy Review and update IRB correspondence Scan CRFs for empty data fieldsDDuurriinngg tthhee AAuuddiitt Give the auditor access to the requested records at the predefined time and place Be available for questions and help locate missing informationTIP SHEET Preparing for an ...