Presentation Delivered at 2012 St. Vincent Health Research Symposium (June 13).

1. Proactive Internal Auditing
Developing Your Team’s Plan for Quality Assurance
Heather Kemp, MBA, CCRP
Director of Research Services
St. Vincent Health Research Symposium
©2011 Franciscan St. Francis Health June 13, 2012

2. Agenda
• What is auditing?
• Why is auditing important to me?
• Can my research team develop an auditing program?
– Who will audit?
– What will they audit?
– Where will they audit?
– When will they audit?
• Is auditing really that easy?
©2011 Franciscan St. Francis Health

3. Key Terms
• Audit, “A systematic and independent examination of trial-
related activities and documents to determine whether the
evaluated trial-related activities were conducted, and the data
were recorded, analyzed, and accurately reported according to
the protocol, sponsor’s standard operating procedures (SOPs),
good clinical practice (GCP), and the applicable regulatory
requirements(s).”
• Monitoring, “The act of overseeing the progress of a clinical trial,
and of ensuring that it is conducted, recorded, and reported in
accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).”
©2011 Franciscan St. Francis Health

4. Key Terms
• Audit, “A systematic and independent examination of trial-
related activities and documents to determine whether the
evaluated trial-related activities were conducted, and the data
were recorded, analyzed, and accurately reported according to
the protocol, sponsor’s standard operating procedures (SOPs),
good clinical practice (GCP), and the applicable regulatory
requirements(s).”
• Monitoring, “The act of overseeing the progress of a clinical trial,
and of ensuring that it is conducted, recorded, and reported in
accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).”
©2011 Franciscan St. Francis Health

5. Key Terms
• Audit, “A systematic and independent examination of trial-
related activities and documents to determine whether the
evaluated trial-related activities were conducted, and the data
were recorded, analyzed, and accurately reported according to
the protocol, sponsor’s standard operating procedures (SOPs),
good clinical practice (GCP), and the applicable regulatory
requirements(s).”
• Monitoring, “The act of overseeing the progress of a clinical trial,
and of ensuring that it is conducted, recorded, and reported in
accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).”
©2011 Franciscan St. Francis Health

6. Monitoring: Theory vs. Actual Practice
• Theoretically, monitoring records should contain, “significant
findings/facts, deviations and deficiencies, conclusions, actions
taken or to be taken, and/or actions recommended to secure
compliance,” (ICH GCP [E6] 5.18.6)
• In reality, monitoring reports generally contain…
– Findings/Facts
– Deviations and Deficiencies
– Actions Taken or to be Taken
©2011 Franciscan St. Francis Health

7. Monitoring: Theory vs. Actual Practice
• Theoretically, monitoring records should contain, “significant
findings/facts, deviations and deficiencies, conclusions, actions
taken or to be taken, and/or actions recommended to secure
compliance,” (ICH GCP [E6] 5.18.6)
• In reality, monitoring reports generally contain…
– Findings/Facts
– Deviations and Deficiencies
– Actions Taken or to be Taken
©2011 Franciscan St. Francis Health

8. Agenda
• What is auditing?
• Why is auditing important to me?
• Can my research team develop an auditing program?
– Who will audit?
– What will they audit?
– Where will they audit?
– When will they audit?
• Is auditing really that easy?
©2011 Franciscan St. Francis Health

9. Importance of Auditing
• Auditing extends beyond monitoring to…
– Identify systemic issues, rather than isolated incidents
– Determine the root cause, rather than merely stating the facts
– Take preventive action, in addition to corrective action
• Internal auditing corrects issues early
• Internal auditing may reduce the impact of external audits
– FDA
– IRB
– Sponsor
©2011 Franciscan St. Francis Health

10. Agenda
• What is auditing?
• Why is auditing important to me?
• Can my research team develop an auditing program?
– Who will audit?
– What will they audit?
– Where will they audit?
– When will they audit?
• Is auditing really that easy?
©2011 Franciscan St. Francis Health

11. HCCA Recommendations
• Mission Statement
• Program Scope
• Roles and Responsibilities
• Line of Authority
– Reporting
– Enforcement / Discipline
©2011 Franciscan St. Francis Health

12. Internal Auditing Procedure
• Who can audit?
– Independent of the investigation (to some degree)
– Background sufficient to conduct the audit (to some degree)
• What will they audit?
– Identify exclusions
– Assess risk
– Consider the “slice and dice” method of auditing
• Where will they audit?
– Consider convenience to the auditor (and to you)
• When will they audit?
– Aim to strike a balance between frequency and value
©2011 Franciscan St. Francis Health

13. Agenda
• What is auditing?
• Why is auditing important to me?
• Can my research team develop an auditing program?
– Who will audit?
– What will they audit?
– Where will they audit?
– When will they audit?
• Is auditing really that easy?
©2011 Franciscan St. Francis Health

14. Internal Auditing Plan
• Stakeholders:
– Who wants you to perform internal audits?
– Who doesn’t want you to perform internal audits?
• Economics:
– Estimate of the cost to conduct audits
– What won’t be getting done during an audit?
• Implementation Timeline:
– What has to happen before the first audit?
– What has to happen before every audit?
©2011 Franciscan St. Francis Health

15. The Million Dollar Question:
What will you do with your audit findings?
©2011 Franciscan St. Francis Health

16. Proactive Internal Auditing
Developing Your Team’s Plan for Quality Assurance
Heather Kemp, MBA, CCRP
Director of Research Services
heather.kemp@franciscanalliance.org
©2011 Franciscan St. Francis Health