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An Approach to Quality Management in an Academic Setting

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Disclosure

We have no financial relationship relevant to this educational activity

Stephanie Gaudreau, CIP

Manager, Office of Human Research Protection

Connie Catha, CCRC

Quality Assurance Analyst

Ochsner Clinic Foundation, New Orleans, LA

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Objectives

• Identify four components of Quality System

Management • Understand the application of the QSM • Evaluate the Effectiveness of QSM

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Ochsner Clinic Foundation

• Network of Hospitals and Clinics • Academic Medical Center • Clinical, Tranlational, Nursing, and Outcomes

Research

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Research Quality Assurance

• History of Program Development • Research Reviews • Lack of Trend Analysis • Lack of Reinforcement of Quality Improvement

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Quality Systems Management

• Continual Process Improvement: ISO 9000,

2000 • Quality Systems Framework: FDA, 2003, 2006,

2009 • Components of a Quality System: CTTI, 2010

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Quality Systems Management

• Say What You Do • Do What You Say • Prove It • Improve It Reference: Janet Woodcock, MD FDA Director of the Center for Drug Evaluation and Research , Developing

Effective Quality Systems in Clinical Trials , CTTI: Oct 2010

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Say What You Do

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Say What You Do

• Collaboration by Research Management • QA incorporated into Office of Human Research

Protection (OHRP) • Policies and Guidances • Standardized Research Tools • IRB, Contract, ICF Observation Reviews

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Say What You Do

Convened IRB Review: • Panel Members • Panel Minutes • Approval/Acknowledgement Documents

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Say What You Do

Pre-Award Contract: • Medicare Coverage Analysis (MCA) • Center for Medicare & Medicaid Services (CMS)

Determination for Device Trials • Consistency between MCA, CMS & Budget

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Say What You Do

Pre-Award Contract….continued: • Consistency between Contract, Protocol &

Informed Consent • Are all required signatures present

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Say What You Do

Post-Award Contract: • Consented Subjects in EMR • Amendments Requiring Changes to Contract &

Budget • Verify Billing Charges • EMR Status

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Say What You Do

Informed Consent Observation: • Version • Location • Explanation • Comprehension • Documentation

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Do What You Say

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Do What You Say

• Policies & Guidances • Quarterly GCP Lectures • IRB Newsletters • Quarterly Research Forums Comprehension • Intranet Resources

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Prove It

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Prove It

Review Process

Notification

QA Review

Study Staff

PI

Summary of Findings

OHRP Manager

IRB Chair

VP Academics

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Prove It

Trend Analysis of Clinical Study Review: • Delegation of Authority, Qualifications, Training • General Regulatory • Informed Consent • Eligibility

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Prove It

Trend Analysis of Clinical Study Review …cont: • Adverse Events • Compliance • General Data Quality • Test Article Accountability

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Prove It

Delegation of Authority Major: • Non-study staff performing study procedures • Incomplete DOA after trial open • Per protocol, unqualified study staff performing

study procedures

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Prove It

Delegation of Authority Minor: • ExpiredDocumentation of Staff Qualifications • PI did not sign and date study staff tasks

promptly

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Prove It

Departments IRB

Delegation of Authority/

Qualifications/ Training

General Regulatory

Major Minor Major Minor Major Minor

PI CRC # Subjects

Anesthesiology

Study #1 Sponsor/Drug

Study #2 Sponsor/Drug

Gastroentrology

Study #1 Sponsor/Drug

Study #2 Sponsor/Drug

Cardiology

Study #1 Sponsor/Drug

Study #2 Sponsor/Drug

TOTALS

0 0 0 0 0 0

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Improve It

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Improve It

• GCP Education of High Risk Findings • New Research Staff 60 day review • Plan meetings with supervisors and managers • Implementation of Contract/Billing Reviews

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Improve It

• Re-education • Updating/Creating Policies/Guidance • Yearly review of Policies/Guidances

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Conclusions

• 4 steps to Quality Systems Management • Changes to the Program to improve Quality • Early Results are Promising

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References

• International Organization for Standardization (ISO); www.iso.org •Quality Management in Clinical Trials, Pfizer www.pfizer.com/files/research/research_clinical_trials/QualityManagement_ClinicalTrials_030209.pdf •Bhatt A. Quality of clinical trials: A moving target: Perspect Clin Res.2011 Oct-Dec;2(4): 124-128 •Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach; Summary of an Expert Meeting , 2010 Oct 13,14 Clinical Trials Transformation Initiative (CTTI); http://www.trialstranformation.org •FDA Information Sheet Guidance for IRBs, Clinical Infestigators, and Sponsors FDA Inspections of Clinical Investigators; http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf

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References

• Morrison BW, Cochran CJ, White JG, Harley J, Kleppinger CF, Liu A et al. Monitoring the quality of conduct of clinical trials, A survey of current practices. ClinTrials.2011;8:342-9

• Risk Assessment: The Health Care Compliance Professional’s Manual; Health Care Compliance Association 40,100-41,009

• Research Compliance Professional’s Handbook: The practical Guide to Building and Maintaining a Clinical Research Compliance & Ethics Program; Health Care Compliance Association, Second Edition

• Standards for Data Management and Analytical Processes in the Office of Surveillance and Epidemiology (OSE); FDA Center for Drug Evaluation and Research Manual of Policies and Procedures MAPP6700.2 , 2008 March

• FDA Staff Manual Guides, Volume III – General Administration : FDA Quality System Framework for Internal Activities SMG 2020

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References

•FDA Office of Scientific Investigations Metrics 2013 Jan; www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM256376.pdf •Marks N. Is Risk Management Part of Internal Control or Is It the Other Way Around? The Institute of Internal Auditors International Conference http://www.theiia.org/blogs/marks/index.cfm/post/Is%20Risk%20Management%20Part%20of%20Internal%20Control%20or%20Is%20It%20the%20Other%20Way%20Around •Stephens V. The Role of Quality Assurance and Quality Control in Clinical Research http://EzineArticles.com/?exoert=Valeria_Stephens •Jones C, Jester P, Casey B Quality Processes at the Clinical Research Site, The Monitor; 2012 Sep, 47-52

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References

• US FDA Guidance for Industry: Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring, 2013 Aug

• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf

• Valania M. Quality Control and Assurance in Clinical Research, Applied Clinical Trials

• http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=310811

• FDA Guidance for Industry Q9 Quality Risk Management 2006 Jun ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073511.pdf

• FDA Guidance for Industry Q10 Pharmaceutical Quality System 2009 Apr; http://www.fda.gov/RegulatoryInformation/Guidances/ucm128030.htm

• Wool L. Intertwining Quality Management Systems with Metrics to Improve Trial Quality; The Monitor , 2012 Aug ; 29-35