Internal Auditing in Research:

The QA Process

Research Education SeriesFebruary 14, 2011

Sarah Dutkevitch, RN, OCN, Clinical Research Nurse SpecialistHeather Kemp, MBA, CCRP, Clinical Research Coordinator

Department of Surgery, General Surgery Section

Agenda / Overview

• Assessing Risk in Auditing• The SOP: Answering the Who, What, Where,

When, Why, and How of Internal Auditing• The Coordinator’s Perspective: Before, During,

and After an Internal Audit

The Research Context

The Research Context

Answer the questions in Section I (page 1) of your handout to assess the context of your research group.

Why is it Audited?

• Compliance• Process Improvement• Education

Who is Audited?

• All research which:– Is not exempt from IRB review;– Is not being conducted under a waiver of informed

consent;– Has subjects enrolled on the study; and– Has not been reviewed by the Clinical Trials

Monitoring Committee in the past 12 months.

What is Audited?

• Informed Consent Documents and Informed Consent Process Documentation

• HIPAA Authorizations• Subject Eligibility• Protocol Compliance (Deviations and Violations)• Subject Safety• Compliance with the DSMP

Sponsored Trials: Exceptions to the Rule

Other Resources1. Toward, J. (2010, November). Contrasting

Health Canada and internal academic audit mechanisms and outcomes. SoCRA Source Journal, 66, 26-31.

2. Austin, DM. (2010, November). Investigational product accountability to ensure audit readiness. SoCRA Source Journal, 66, 42-46.

3. Korieth, K. (2011, February). The high cost and questionable impact of 100% SDV: Sponsors, CROs reluctant to alter standard practice. The CenterWatch Monthly, 18(2), pp.1, 15-17.

Answer the questions in Section II (page 2) of your handout to assess the risks inherent in your research group.

Where and When is it Audited?• Audits are Conducted in the Office/Clinic/Lab Where Study

Charts are Stored• Audits Fall in the Middle of the Continuing Review Cycle (±2

Months)

Where and When is it Audited?• Audits are Conducted in the Office/Clinic/Lab Where Study

Charts are Stored• Audits Fall in the Middle of the Continuing Review Cycle (±2

Months)• The Auditor Provides Written Notification to the PI and Lead

Study Coordinator Approximately Two Weeks in Advance

The Email NotificationRE: Internal Audit of Study No. [IRB No.] Dear Dr. [Name]: This email is to remind you that the above-referenced study is scheduled to be audited on [Date]; I will be reviewing the records for all subjects enrolled since the last continuing review approval (Date). I will coordinate the audit with the primary research coordinator on this study, [Name], and will disseminate the findings to the team afterward. Attached to this email are three documents for your reference:•A copy of the internal audit template that will be used to direct the audit proceedings;•a copy of the General Surgery internal auditing SOP; and•a copy of the General Surgery Research Compliance Tip Sheet.

If you have any questions about protocol compliance, please feel free to contact me at your convenience. CC: [Research Coordinator]

Where and When is it Audited?• Audits are Conducted in the Office/Clinic/Lab Where Study

Charts are Stored• Audits Fall in the Middle of the Continuing Review Cycle (±2

Months)• The Auditor Provides Written Notification to the PI and Lead

Study Coordinator Approximately Two Weeks in Advance• Audits are Scheduled Using Outlook (Appearing on the

Research Staff’s Calendar)• The PI and Research Staff are Not Present During the Audit• The Audit Findings are Disseminated in Writing to the PI,

Research Staff, and Regulatory Staff Following the Internal Audit

Answer the questions in Section III (page 2) of your handout to consider the auditing logistics appropriate for your research group.

How is it Audited?

• Informed Consent Documents and Informed Consent Process Documentation

• HIPAA Authorizations• Subject Eligibility• Protocol Compliance (Deviations and Violations)• Subject Safety• Compliance with the DSMP

How is it Audited?• Proper ICS Version and Pagination• Proper IRB Approval Stamp(s) on ICS• Proper ICS Execution• Informed Consent Process Note Review• Proper HIPAA Authorization Version and

Pagination• Proper IRB Approval Stamp on HIPAA

Authorization• Proper HIPAA Authorization Execution• Medical Records Documentation (VA Only)

How is it Audited?

• Informed Consent Documents and Informed Consent Process Documentation

• HIPAA Authorizations• Subject Eligibility• Protocol Compliance (Deviations and Violations)• Subject Safety• Compliance with the DSMP

How is it Audited?• Subject Eligibility– Eligibility Checklist Review and Source Document Verification

(Sampling)

• Protocol Compliance– eCRF Review and Source Document Verification (Sampling)

The Compliance Log

How is it Audited?• Subject Eligibility– Eligibility Checklist Review and Source Document Verification

(Sampling)

• Protocol Compliance– eCRF Review and Source Document Verification (Sampling)

• Subject Safety– Regulatory File Review– eCRF Review and Source Document Verification (Sampling)

The Safety Log

How is it Audited?• Subject Eligibility– Eligibility Checklist Review and Source Document Verification

(Sampling)

• Protocol Compliance– eCRF Review and Source Document Verification (Sampling)

• Subject Safety– eCRF Review and Source Document Verification (Sampling)– Regulatory File Review

• DSMP Compliance– Regulatory File Review

Answer the questions in Section IV (page 2) of your handout to consider the internal auditing priorities for your research group.

The Coordinator’s Perspective

1. “An ounce of prevention is worth a pound of cure.”

Answer Question 1 in Section V (page 3) of your handout to brainstorm some “preventative actions” for your research practice.

The Coordinator’s Perspective

1. “An ounce of prevention is worth a pound of cure.”

2. Leave a trail of “bread crumbs” for the next person.

Answer Question 2 in Section V (page 3) of your handout to assess how detailed, organized, and reliable you are in your research practice.

The Coordinator’s Perspective

1. “An ounce of prevention is worth a pound of cure.”

2. Leave a trail of “bread crumbs” for the next person.

3. Prep for the “big day”.

The Coordinator’s Perspective

1. “An ounce of prevention is worth a pound of cure.”

2. Leave a trail of “bread crumbs” for the next person.

3. Prep for the “big day”.

4. Turn that frown upside down.

Answer Question 3 in Section V (page 3) of your handout to identify opportunities to promote internal auditing.