the role of quality assurance in eclinical environments – when to dive in

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

Shiela McLaughlinInternational Director, Quality Assurance

DATATRAK International, Inc.

The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.

These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.

Disclaimer

Confidential – 3

• 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

Confidential – 3

• 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

Confidential – 3

• 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

Confidential – 3

• The Old Model

The Software Development Lifecycle (SDLC)

Confidential – 3

• The New Model

The Software Development Lifecycle (SDLC)

Confidential – 3

• 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

Confidential – 3

• Utilize a Subject Matter Expert (technical representation)

• Check training records and employee qualifications

• Check client references

Auditing Your Software Vendor

Confidential – 3

• 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

Confidential – 3

• Consolidation of electronic data

eSource / eClinical - The FDA’s Preferences

Confidential – 3

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

Confidential – 3

from Concept to Cure

with DATATRAK ONE

DATATRAK InternationalCleveland, Ohio Bryan, Texas Cary, North Carolina

888.677.DATA (3282) Toll Freewww.datatrak.net

®

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