ICH - GCP E6(R3) Comprehensive Resource Guide for Clinical Research Professionals : Practical Insights and Key Updates for Clinical Study Design and Application

Language: English

Published by Independently Published Dez 2024, 2024

9798303188594

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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Neuware - Master the latest updates and principles of ICH GCP E6(R3) with this indispensable guide for clinical research professionals. This comprehensive resource provides a clear and practical exploration of the ICH GCP E6(R3) guideline, equipping professionals with the tools and insights needed to excel in clinical research. From foundational principles to the latest advancements in trial design and data management, this guide is your essential companion for navigating the complexities of modern clinical studies. Topics covered in this book include: - Introduction to ICH GCP E6(R3): Understand the evolution and importance of GCP in clinical research.- Investigator and Sponsor Responsibilities: Key obligations to ensure compliance, participant safety, and trial success.- Ethics and IRB/IEC Oversight: Safeguard participant rights and maintain ethical standards throughout the trial.- Digital and Computerized Systems: Strategies for secure data management and regulatory compliance in the digital age.- Monitoring, Auditing, and Risk Management: Proactive approaches to quality assurance and issue resolution.- Protocol Development and Essential Records: Practical guidance for effective documentation and operational excellence.- Annex 2 Insights: Adapt GCP principles to decentralized, pragmatic, and real-world data trials.Whether you're a seasoned professional or new to clinical research, this book offers actionable guidance, real-world examples, and clarity on ICH GCP E6(R3)'s key updates. Elevate your expertise, prioritize participant welfare, and ensure trial integrity with this essential resource. Perfect for: - Clinical Research Professionals- Investigators and Sponsors- Regulatory and Compliance Specialists- IRB/IEC Members- Anyone who has an interest in Clinical Research Regulatory TopicsPrepare to lead with confidence in the ever-evolving world of clinical research. Pick up your copy of ICH - GCP E6(R3) Comprehensive Resource Guide for Clinical Research Professionals: Practical Insights and Key Updates for Clinical Study Design and Application right now.

Seller Inventory # 9798303188594

Title
ICH - GCP E6(R3) Comprehensive Resource Guide for Clinical Research Professionals : Practical Insights and Key Updates for Clinical Study Design and Application
Author
Alec Spinelli
Publisher
Independently Published Dez 2024
Publication year
2024
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 13
9798303188594
Item weight
194 grams
Dimensions
229x152x10 mm

AHA-BUCH GmbH

Einbeck, Germany

5-star seller

AbeBooks seller since August 14, 2006

Shipping rates from Germany to U.S.A.

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