internal Quality Assurance Program...Edgar Cayce 40 Office of Research Compliance and Regulatory...

HCCA Research Compliance Conference May 31-June 3, 2015

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Embracing Quality:

One Institution’s Approach to Managing Compliance Risks

Marsha C. Wallace, M.H.A./Ed., R.N., C.C.R.C.

Office of Research Compliance and Regulatory Affairs

Objectives

• Describe practical considerations and approaches to developing an internal quality assurance program for human subject research

• Identify and prioritize potential risks

• Discuss strategies for overcoming challenges when implementing an internal audit program

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…the road to establishing an internal Quality Assurance Program

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Key Questions

“I never learn anything talking. I only learn things when I ask questions.” Lou Holtz

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FREQUENTLY ASKED QUESTIONS

• Why do we need an internal quality assurance program?

• What are the risks and concerns?

• Who will be our target audience/stakeholders?

• How to plan for effective implementation of an internal quality assurance program?

• How to effectively disseminate information and provide quality feedback?

• What are the thresholds for corrective actions?

• What are some strategies to overcome challenges and positively impact the research community?

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What is the purpose?

• Why do we need an internal quality assurance program?

• Patient safety – Protection of Human Subjects

• Monitor compliance – IRB, regulatory requirements (FDA) and GCP guidelines

• Monitor the conduct of the study

• Perform over-site review of all new, existing and continuing trials (IND/IDE)

• Preparation for internal sponsor audits, NIH/FDA audits

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• Assure study data is accurate, complete and verifiable

• Identify strengths and target areas for quality improvement initiatives

• Provide educational resources and guidance for best practice

• Assure validity and completion of data

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Attributable Risks

• What are the risks and concerns?

– Risks to institution, investigator, research subject

– How many Investigator-initiated studies?

• Investigational New Drug (IND)

• Investigational Drug Exemption (IDE)

– How many studies lack external monitoring?

• NIH, DOD, Foundation(s) sponsored studies

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http://www.graphicsfactory.com/cgi-bin/affiliate/clickthru.cgi/freec/


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Who are the Stakeholders?

• Research community

• Research Administration

• Ethics Board (Institutional Review Board)

• Researchers

• Study team members

• Research subjects

• Industry collaborators

• Regulatory agencies

• Funding agencies

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Organizing an Internal QA Program

• What are the priorities? – Quality assurance

– Quality control

– Quality improvement

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• Program structure?

• How to identify gaps?

• Who will be accountable?

–Reporting relationships

• Corporate Compliance

• Research Administration

–Developing corrective actions

• Minimize and manage risks 13

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Program Structure Goal

Supportive and educational

- Preventative

- Assessment/Identification of findings

- Corrective Actions


• What are the standards?

–Policies and procedures

–Training

–Implementation

–Reporting requirements

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.…the great debate

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Quality Assurance

vs.

Quality Control

Are they the same?

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Quality Control (QC) Monitoring

“The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.”


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Quality Assurance (QA) Auditing

“All those planned and systematic actions

that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements.”

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QA vs. QC Are they the same?

QC is NOT QA

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Quality Review Plan

• Monitor compliance – Regulations & GCP standards

• Monitor the conduct of the study

• Perform over-site review of all new, existing and continuing trials (IND/IDE)

• Preparation for internal sponsor audits, NIH/FDA audits




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What are the types of QA reviews conducted?

• For cause reviews:

– a request from the IRB, Research Administration or some other group has raised concerns and issues related to the conduct of the research.

• Routine reviews:

– process of randomly selected review of IRB approved studies.

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What types of research studies are reviewed?

• Any active clinical research study

• All disciplinary areas

• Generally, no outside monitor

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Quality Review Plan

• When?

– Before (pre-study review)

– Randomly

– Annually


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Quality Review Plan

• What to Audit?

– Protocol

– Informed Consent

– Case Report Forms (CRF’s)

– Compliance with eligibility criteria

– Adverse Event Reporting

– Compliance to FDA/ICH Guidelines

– Documentation for compliance to IRB, FDA (GCRC, NIH, if applicable)

What do we review?

• 100% review of essential documents (regulatory files)

• Informed consent documents

• Study Documents

• Study management tools

• Subject study records (10%)

• Case Report Forms (data collection tools)

• Source documents

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QA Review Process

• Study identified

• Principal investigator (PI) notified

• Brief meeting with PI and study team

• Review conducted

• Exit interview

• Written report of findings: regulatory issues and best practice recommendations

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What do we look for?

• Regulatory compliance

• Protocol compliance

• Adherence to institutional policies and procedures

• Areas of potential risk

– Human subject risk

– Institutional risk

• Identify strengths and opportunities for improvement

• Assess resources as well as educational needs

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How will information be disseminated?

• Oral and written communication

– Regulatory and professional obligation

– Opportunities for improvement

• Training and education

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For Cause

Routine Audit Preparation

Minimal Risk

REVIEW SUMMARY

Principal

Investigator:

Coordinator:

Date of Review: Reviewed

By:

IRB#:

Protocol Title:

Source of Funding:

Enrollment Status: (√ check one)

Open Closed

# Subjects IRB

Approved:

Current Enrollment:

Subject Record Verification:

# Subject Specific Records Reviewed/ID#:

# Consent Documents Reviewed:

GENERAL COMMENTS

REGULATORY/PROFESSIONAL

OBLIGATION

OPPORTUNITIES FOR IMPROVEMENT REGULATORY

CITATION/ BEST PRACTICES

REGULATORY/SOURCE DATA/

DOCUMENTATION:

IRB approval is obtained

and maintained until the

study’s completion.

No study-related

assessments/procedures

performed prior to IRB

approval.

Study team personnel

assisting in the conduct of

the study are informed of

their obligations in

meeting the study

commitments.

21 CFR 56.108

45 CFR 46.103.(b)4, 5

CHOP Policy #A-3-9:

Retention and Destruction

of Records, (v. 9/30/10)

ICH/GCP Good Clinical

Practice Guidelines

How are QA review findings documented?

• QA Summary Monitoring Report using the following categories:

• Regulatory/Source Data/Documentation

• Informed consent

• Protocol adherence/Eligibility

• Financial Considerations

• Unanticipated problems/SAE reporting

• Data Security

Note: Investigator-Initiated studies (IND/IDE)

-Review of Investigational product accountability

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What are some common QA review findings?

• Incomplete documentation of consent;

• Inclusion/exclusion criteria not met;

• Deficiencies in maintaining documentation;

• Lack of and limited documentation of delegated responsibilities;

• Lack of source data/documents and

• Incomplete or missing data collection tools (including questionnaires, surveys, case report forms (CRFs).

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How are findings communicated?

• Oral and written communication provided

– Principal Investigator/Study Team • Address regulatory and professional obligations

– IRB (as applicable)

• Referred studies

• Reportable event

– Protocol deviation

– Significant non-compliant findings

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For Cause

Routine Audit Preparation

Minimal Risk

REVIEW SUMMARY

Principal

Investigator:

Coordinator:

Date of Review: Reviewed

By:

IRB#:

Protocol Title:

Source of Funding:

Enrollment Status: (√ check one)

Open Closed

# Subjects IRB

Approved:

Current Enrollment:

Subject Record Verification:

# Subject Specific Records Reviewed/ID#:

# Consent Documents Reviewed:

GENERAL COMMENTS

REGULATORY/PROFESSIONAL

OBLIGATION

OPPORTUNITIES FOR IMPROVEMENT REGULATORY

CITATION/ BEST PRACTICES

REGULATORY/SOURCE DATA/

DOCUMENTATION:

IRB approval is obtained

and maintained until the

study’s completion.

No study-related

assessments/procedures

performed prior to IRB

approval.

Study team personnel

assisting in the conduct of

the study are informed of

their obligations in

meeting the study

commitments.

21 CFR 56.108

45 CFR 46.103.(b)4, 5

CHOP Policy #A-3-9:

Retention and Destruction

of Records, (v. 9/30/10)

ICH/GCP Good Clinical

Practice Guidelines

Findings: Regulatory Issues

• Any break with regulatory compliance as it relates to study management and the IRB approved protocol and/or federal regulatory requirements

• Finding is reported to the PI of the study and IRB is notified

• The IRB has the regulatory authority to review, make determinations about non compliance and report to the appropriate federal regulatory agency

• IRB determines seriousness of finding • IRB sets corrective action • Collaborative effort to confirm completion of corrective

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Findings: Best Practices

• Any finding that indicates a need for improvement in study management or study documentation

• Best practice recommendations provided to study team in the form of standard operating procedures, templates, policy

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Findings: Best Practices

• Best practice issues and solutions are presented in workshops and incorporated into study coordinator trainings

• Note: these are not regulatory findings

• Minimal risk studies, unlike clinical trials, do not have best practice standards and thus we are developing them

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Overcoming Challenges

• Changing the culture

• Support from leadership

• Engaging leadership and research community

• Resources

• Planning and implementing changes

• Disseminating policies and procedures

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How to make a positive impact?

• Be proactive

• Be transparent

• Determination, commitment and perseverance

• Focused, coordinated and consistent approach to monitoring and reporting

• Effective and consistent communication

• Knowledgeable, skilled and professional staff

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What Resources are Available?

– Research QA Policy and Procedure

– Research QA Monitoring and Audit Preparation Tools • Preparing for regulatory agency site visit

• Self-audit checklist

– Research QA Frequently Asked Questions (FAQs)

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Final Thoughts

• Strategies for implementing an effective internal QA program

– Ensuring safety and compliance

– Demonstrate internal control

– Minimize and manage risks

– Develop educational activities

– Process improvement

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“Dreams are today's answers to tomorrow's questions.” Edgar Cayce

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Matthew Hodgson, M.S. Director, Research Compliance and Regulatory Affairs

Research Quality Assurance and Monitoring Clinicaltrials.gov Protocol Registration/Results Data Reporting Marsha Wallace, R.N., M.H.A./Ed., CCRC

Assistant Director, Quality Assurance and Monitoring Shonda Evans, B.A.

Research Quality Assurance Monitor Meredith Gross, M.S., CCRC

Clinical Research Associate II Christina McGee, M.S., CCRC, CCRA

Senior Clinical Research Associate Kim Grazionale

Research Regulatory Analyst Post- Approval Monitoring- Institutional Animal Care and Use Committee (IACUC) protocols Denise Ancharski-Stutler, M.S., CPIA Post-Approval Monitor/Compliance Liaison Research Information Security Diana Tursi, CISSP, CISM, CISA

Research Information Security Analyst Institutional Review Board (IRB)/Executive IRB Support Staff Amy Schwarzhoff, B.S., CIP

Director, Human Subjects Research

Compliance Hotline: 1-866-246-7456 or Online Compliance Reporting: www.mycompliancereport.com

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Questions???

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References • Department of Health and Human Services Regulations

(HHS)

http://www.hhs.gov/policies/index.html

• Food and Drug Administration (FDA) www.fda.gov

• ICH Guidelines E6 Good Clinical Practice: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

• Office for Human Subject Protections (OHRP)

http://www.hhs.gov/ohrp/

• ORCRA Intranet

https://intranet.research.chop.edu/display/deptcomp/Research+QA+Monitoring

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Thank You!

Marsha Wallace, M.H.A./Ed., R.N., C.C.R.C. Assistant Director, Research QA/Monitoring


Children’s Hospital of Philadelphia

Email: [email protected]

Phone: 215-590-0119

http://www.hhs.gov/policies/index.html

http://www.fda.gov/

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

http://www.hhs.gov/ohrp/




mailto:[email protected]

internal Quality Assurance Program...Edgar Cayce 40 Office of Research Compliance and Regulatory...

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