AUDIT PREPARATION TOOL Present and Present and Document – Document Investigator – Reviewed Reviewed Investigator Regulatory Comments Comments Regulatory Files Y/N/NA Y/N/NA Files Protocol & Amendments R&D Correspondence Approved Case Report Forms IRB Approved Consent Site-Sponsor Correspondence, if app. -Information Provided to -Conference call minutes Subjects -E-mails -HIPAA Forms -Newsletters -Advertisements -Conference -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 Investigational Products, if Investigator applicable Brochure/VA Form Accountability, Handling, Pharmacy, Elsewhere Are there local IRB requirements for record keeping? Yes No NA Comments:
AUDIT PREPARATION TOOL Document – Investigator Regulatory Files 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 Forms IRB Approved Consent -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 -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 Investigator Brochure/VA Form Investigational Products, if applicable Accountability, Handling, Pharmacy, Elsewhere Are there local IRB requirements for record keeping? Yes No NA Comments:
2017-2018_HRPP_Audit_Tool.docx