Leveraging Your EDC Application to

Mitigate Risk in Clinical Trials

March 25, 2015

Confidential –

Your Speaker

► Bill Gluck, Ph.D.

• Dr. Gluck has over 30 years of expertise in clinical research, with experience in sponsors, CROs, and with DATATRAK in a variety of roles. Dr. Gluck is also the Program Director for the Clinical Trials Research and Medical Product Safety/Pharmacoviligance programs at Durham Technical Community College. Dr. Gluck earned his Bachelor of Science Degree at the University of Scranton and Master and Ph.D. degrees from North Dakota State University.

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Confidential –

Our Discussion Topics

• Definition and Perception of ‘Risk’

• Risk-Based Quality Management

• How Can We Mitigate Our Risk Profile

– Approaches to Reducing Risk

– Review, Report, Communicate

– Leveraging Technological Tools

• Summary

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Every Clinical Trial Has Inherent Risk and

Every Risk Has a Tolerance Limit

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Risk

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Risk is an uncertain event

or condition that, if it

occurs, has an effect on at

least one objective.

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Mitigating Risk

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Taking steps to reduce adverse effects.

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Tolerance

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There is no way a sponsor

can eliminate all risks of

doing clinical trials so

defining the amount and

identifying the type of risk

that a sponsor is willing to

accept helps them evaluate

where resources should

allocated to minimize the

most significant risks.

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Perception of Risk

Role and Responsibilities

– Sponsor

– Investigator

– IRB/Ethics Committee Member

– Quality Representative

– Regulator

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Risk-Based Quality Management

• Start with Quality – End with Quality

– A systematic process to identify, assess, control,

communicate, and review risks associated with the trial

throughout the life of the trial

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Approach To

Risk

Mitigation

Identify & Assess

Control

Review & Communicate

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Identify and Assess Risk

• Privacy Protection of Study Participants

• Patient/Subject Safety

• Quality/Reliability of Study Data

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Controlling Risk

• What decisions can be made to reduce and/or

accept risk?

• Where can we mitigate risk?

• How can we accomplish this?

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Review and Communication

• Document your process

• Communicate the process

• Review results

• Incorporate new information

• Update and revise your plan as needed

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Develop and Implement A Plan

• Building on the answers

– Develop a plan

– Implement action for high risk

– Understand there may be implications with low risk

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How Do We Do This?

• Separate prioritization from risk mitigation

• Address each stage of the trial

• Stratify/Customize the plan

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Setting Boundaries – Early and Often

• Trial Data

• Monitor Protocol Compliance/Deviations

• Establish Qualification Standards/Specifications

• Define Metrics to Allow Oversight

– Data Collection, Retrieval, and Reporting

– RBM

– Quality Measures

Confidential –

A Sample Template

Header Categories

Risk Area/Category

Potential Risk Assessed

Risk Examples/List study specific issues

Include in Monitoring Plan (Yes/No)

Tolerance Threshold

Mitigation Strategies/Tools to be Used

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Sample Template Header

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Risk Assessment

Worksheet

Risk Area/Category Potential Risk Assessed Risk Examples (list study specific

issues)

Include in

Monitoring Plan

(Yes/No) Tolerance Threshhold Mitigation Strategy/Tools to be

Used

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Study Conduct Quality Management System-Sponsor

Level

Is there a sponsor level QMS in place,

at the CRO/support company level, at

the site level?

Required Regulatory Reporting

Does the sponsor have the

infrastructure to support the required

regulatory reporting needed? Does the

supporting organization have the

infrastructure? Does the site have a

QMS or the essential quality controls in

place?

Specific Study Activities

Informed consent process, enforcement

of INC/EXC, handling protocol

deviations/violations, stopping rules,

SAE handling, dose modifications, etc.

Investigational Product

Is there investigational product in place

to conduct the study, is there a re-

supply process, is the supply chain

establsied, are there regulatory risks for

international studies/transport/storage

of the investigational product?

Safety Concerns

Study participant protection and well-

being processes/procedures in place,

safety monitoring, know adverse

evetns/reactions, process for

documetnation and reporting of

unexpected events and SAE's

Study specific tasks

Endpoints, complexity of the study,

stage of the study, number of potential

study participants and geographic

availability

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Leverage Technological Tools – Focus on EDC

► CTMS Applications

► EDC Application

• Platform – Trial-by-Trial Reporting Tools

• Platform – Cross Study Managers/Filters/Reporting Tools

• Performance/Quality Tools

► Safety Application

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Confidential –

Reporting Quality – Leverage Technology

Critical in Today’s Trials

• Trial Data

• Monitor Protocol Compliance/Deviations

• Establish Qualification Standards/Specifications

• Define Metrics to Allow Oversight

– RBM

• Frequency

• SDV

– Data Collection, Retrieval, and Reporting

– Performance/Quality Measures

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Summary

• Risk based approach starts in planning the program

not the study

• Know, Understand, and Use Available Tools

• Adapt protocol-by-protocol throughout the program

– Learn as you go

– Adapt as you go

– Improve as you go

• Communicate, communicate, communicate

– Allow for sponsor and regulatory interactions

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Questions

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Confidential –

Contact Information

► Bill Gluck, Ph.D.

• Bill.Gluck@DATATRAK.com

► General Questions about DATATRAK

• Dorothy.Radke@DATATRAK.com

► Find Us Online

• www.DATATRAK.com

• http://www.slideshare.net/DATATRAK

• @DATATRAKinc on Twitter

• https://www.linkedin.com/company/datatrak-international

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