The Role of Quality Assurance in eClinical Environments – When to Dive in

Shiela McLaughlinInternational Director, Quality Assurance

DATATRAK International, Inc.

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Disclaimer

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• Quality Assurance’s Role in eClinical Technologies► 3rd Party Software/ COTS► The Software Development Lifecycle (SDLC)► Auditing Your Software Vendor

• eSource / eClinical – The FDA’s Preferences

Introduction

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• 3rd party software / COTS• Software developed in-house

► Do you have a Software Development Lifecycle?► Does your process comply with applicable

regulations

• Outsourced / Vendor► Have you qualified the vendor?

QA’s Role in eClinical Technology

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• Is it being modified or will it be used for its intended purpose?

• Does it require validation?• Do you have a process / resources to validate?

3rd Party Software / COTS

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• The Old Model

The Software Development Lifecycle (SDLC)

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• The New Model

The Software Development Lifecycle (SDLC)

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• Know the contract going into the audit• Don’t assume they know the regulations• Review their Software Development Lifecycles

► Development and release processes► Disaster Recovery and Business Continuity► Security processes and monitoring► Support services

Auditing Your Software Vendor

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• Utilize a Subject Matter Expert (technical representation)

• Check training records and employee qualifications

• Check client references

Auditing Your Software Vendor

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• General Principles of Software Validation: Final Guidance for Industry and FDA Staff (January 2002)

• Guidance for Industry, Electronic Source Documentation in Clinical Investigations (December 2010)

eSource / eClinical - The FDA’s Preferences

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• Consolidation of electronic data

eSource / eClinical - The FDA’s Preferences

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Image from FDA’s DRAFT GUIDANCE: Electronic Source Documentation in Clinical Investigations (December 2010)

• The use of technology and software in the clinical industry will only continue to increase

• The involvement of Quality Assurance is becoming increasingly important

• Regulatory bodies are recognizing and encouraging use of technology in the clinical industry

Conclusion

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from Concept to Cure

with DATATRAK ONE

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