How to Make Efficient FDA-Compliant Clinical Protocol Amendments

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On an average a clinical protocol gets amended anywhere from 3-6 times after it has been finalized. Most protocol amendments happen for ongoing studies and require re-consenting subjects, and numerous operational and regulatory updates including FDA review and IRB approval prior to implementing an amended clinical protocol. Protocol amendments are not only operationally burdensome; they could also impact the scientific validity of the study, if not appropriately designed or implemented. Surveys have shown that each protocol amendment costs anywhere from $72,000 to as much $500,000 adding to the study budget and causing delays. However, protocol amendments increase the odds of successful completion of a given clinical trial, and increase the probability of getting the desired outcome. Sponsors and clinical project teams must create rules for when a protocol must be amended, and the best practices to create and implement an FDA-acceptable protocol amendment.

Why should you attend:

This webinar, presented by a leading clinical protocol expert will discuss FDA expectations from protocol amendment process, and best practices for avoiding errors and accidents. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for clinical project teams using case studies and examples from the presenter’s vast experience helping large and small clinical trials in dealing with deviations, safety issues, and operational limitations that lead to protocol amendment. The webinar will provide tips for deciding when an amendment is necessary, the best practices for creating and implementing a protocol amendment without disrupting the study. Amendment to conventional, adaptive design, compassionate-use, and investigator-led clinical studies will be discussed with suggestions from a FDA-acceptance perspective. The seminar is designed to provide a well-rounded training to all stakeholders in all aspects of the creating and implementation of clinical protocol amendment.

Areas Covered in the Session:

·Five common reasons for amending a clinical protocol

·When a protocol should not be amended

·FDA expectations from protocol amendment process

·Operational aspects of protocol amendment

·Statistical issues that must be considered when amending protocols

·Differences between protocols for drugs, biologics and medical devices

·Best practices for training and monitoring clinical sites during and after protocol amendment

·Common FDA audit findings for improperly amended protocols and potential solutions 

Who will benefit:

·Clinical research associates

·Clinical project managers

·Medical writers


·Regulatory affairs personnel

·Quality assurance personnel

·Vice presidents, Directors and Managers

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients. 

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.

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