AUDIT PREPARATION TOOL Present and Present and Document – Document Investigator – Reviewed Reviewed Investigator Regulatory Comments Comments Regulatory Files Y/N/NA Y/N/NA Protocol & Amendments R&D Correspondence Approved Case Report Notes-to-File IRB Approved Consent Site-Sponsor Forms Correspondence, if app. -Information Provided to -Conference call minutes Subjects -E-mails -HIPAA Forms -Newsletters -Advertisements -Conference calls -Record of Approved -Letters, memos, faxes Consent Form Versions Site Personnel Subject Log Signatures, Qualifications, (current/accurate) Training, Scope of Practice, CVs, Delegation Signed Attestation or IRB Correspondence Investigator’s Agreement (Sponsor, Institution, FDA) IRB Submissions, Official Documents Notifications, Approvals Letters, Memos, etc. Serious Adverse Signed PI Conflict of Events/Safety Reports Interest/Disclosure Statement
AUDIT PREPARATION TOOL Document – Investigator Regulatory Present and Reviewed Y/N/NA Comments Document – Investigator Regulatory Files Present and Reviewed Y/N/NA Comments Protocol & Amendments R&D Correspondence Approved Case Report Notes-to-File IRB Approved Consent Forms -Information Provided to Subjects -HIPAA Forms -Advertisements -Record of Approved Consent Form Versions Site-Sponsor Correspondence, if app. -Conference call minutes -E-mails -Newsletters -Conference calls -Letters, memos, faxes Subject Log (current/accurate) Site Personnel Signatures, Qualifications, Training, Scope of Practice, CVs, Delegation IRB Correspondence Signed Attestation or Investigator’s Agreement (Sponsor, Institution, FDA) IRB Submissions, Notifications, Approvals Official Documents Letters, Memos, etc. Serious Adverse Events/Safety Reports Signed PI Conflict of Interest/Disclosure Statement
2013-14_HRPP_Audit_Tool.docx