Reasons for Auditing There are many reasons for auditing. Some examples of these reasons might be: Requested by the IRB Committee Requested by an IRB Reviewer Requested by an Institutional Official Randomly for monitoring purposes Can you think of any others?

Preparing for an Audit When preparing for an audit remember that … Communication is key to a successful audit You should make certain that all necessary key personnel are involved Create the proper atmosphere (the auditor is there to help, not pass judgement) Plan on having an opening and closing meeting to review initial findings with the auditor and inform those involved of the next steps

Reporting the Audit Findings Performing the Audit and Reporting the Audit Findings Prior to performing the audit, the auditor will determine the sample size (whether it be a point-in-time review, or general sampling), you should be prepared for either When reporting the audit findings, it is important to establish documentation standards create and use tools to make certain necessary elements are reviewed add recommendations for improvement

Typical Areas of Review During an Audit Regulatory Documentation Are all versions of the protocol on file? Is all Informed Consent documentation on file? Is there a CV for all key personnel (that is signed and dated within the last two years)? Are there Training Records available for all Key Personnel? Is there a Monitoring Log, and is it current? Is there a Staff Signature / Delegation Log?

Typical Areas of Review During an Audit IRB Documentation Is all the IRB correspondence available? Are all Approvals / Continuations on file? Have all Amendments been documented and on file? Have all Unanticipated Problems / Adverse Events been documented and reported per the protocol? Are there any protocol deviations and/or violations, and if so, have they been properly reported and documented?

Typical Areas of Review During an Audit Participant Records Do participant records follow the protocol? Have participants been recruited properly? Has Inclusion / Exclusion criteria been met? Have all the participants been consented properly? Do all consent documents contain the correct signatures, initials, and dates? Was correct version of the consent document used? Has the HIPAA Authorization been signed and dated, if applicable?

Typical Areas of Review During an Audit Record Keeping Is all regulatory documentation properly stored and organized? Is all IRB documentation properly stored and organized? Are there separate study files for each participant? Are the participant study files stored securely to avoid breach of confidentiality?