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Author: Pramod M. Lad Publisher: ISBN: 9781795730549 Category : Examinations Languages : en Pages : 269
Book Description
PRODUCT DESCRIPTION This study guide provides one tool for the preparation and study for the CIP examination. It is a companion book to the CIP Exam Workbook. The sequence of chapters in the study guide follows the same sequence as in the CIP exam workbook and the flow of ideas in each chapter is concordant with the sequence of questions in the workbook. It is recommended that the two books be studied together for the most effective exam preparation. The study guide is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The study material is designed to instruct on core information relevant to the examination. However it is hoped that the study guide can also function as an IRB Handbook. The study guide is therefore designed not only to prepare for the CIP examination but also to educate IRB professionals and Clinical Research Coordinators on matters which arise frequently in IRB administration. The Institutional Review Board (IRB) is responsible for the review of a wide variety of clinical research. As the complexity of clinical research has grown over the years, the duties and responsivities of the IRB have grown increasingly complex. This complex environment demands that the IRB be staffed and managed by professionals. As a part of affirming the professionalism of IRB staff, administrators and directors the Public Responsibility in Research and Medicine (PRIM&R) provides an important forum for education and affirmation of ethical standards for the performance and management of clinical research. An important component of this program is the certification exam known as the CIP (Certified IRB Professional). This examination which is offered twice a year covers a wide range of regulatory topics.The book addresses the key issues in federal regulations outlined in statutes including Title 45 part 4 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CIP exam covers material based not only on these regulations but also on guidances issued by OHRP and the FDA. Special attention has been devoted to material covered in these guidances. Also addressed are interactions of the IRB with other committees in the institutional environment.
Author: Pramod M. Lad Publisher: ISBN: 9781795730549 Category : Examinations Languages : en Pages : 269
Book Description
PRODUCT DESCRIPTION This study guide provides one tool for the preparation and study for the CIP examination. It is a companion book to the CIP Exam Workbook. The sequence of chapters in the study guide follows the same sequence as in the CIP exam workbook and the flow of ideas in each chapter is concordant with the sequence of questions in the workbook. It is recommended that the two books be studied together for the most effective exam preparation. The study guide is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The study material is designed to instruct on core information relevant to the examination. However it is hoped that the study guide can also function as an IRB Handbook. The study guide is therefore designed not only to prepare for the CIP examination but also to educate IRB professionals and Clinical Research Coordinators on matters which arise frequently in IRB administration. The Institutional Review Board (IRB) is responsible for the review of a wide variety of clinical research. As the complexity of clinical research has grown over the years, the duties and responsivities of the IRB have grown increasingly complex. This complex environment demands that the IRB be staffed and managed by professionals. As a part of affirming the professionalism of IRB staff, administrators and directors the Public Responsibility in Research and Medicine (PRIM&R) provides an important forum for education and affirmation of ethical standards for the performance and management of clinical research. An important component of this program is the certification exam known as the CIP (Certified IRB Professional). This examination which is offered twice a year covers a wide range of regulatory topics.The book addresses the key issues in federal regulations outlined in statutes including Title 45 part 4 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CIP exam covers material based not only on these regulations but also on guidances issued by OHRP and the FDA. Special attention has been devoted to material covered in these guidances. Also addressed are interactions of the IRB with other committees in the institutional environment.
Author: Elizabeth A. Bankert Publisher: Jones & Bartlett Learning ISBN: 9780763730499 Category : Medical Languages : en Pages : 568
Book Description
This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. The updated Second Edition includes seven new chapters: IRB Closure of Study Files, Internet Research, Research in Public Schools, Phase I Clinical Trials in Healthy Volunteers, Vulnerability in Research, Balancing the Risks and Potential Benefits,and HIPAA.
Author: Lynn Machin Publisher: Critical Publishing ISBN: 1914171160 Category : Education Languages : en Pages : 236
Book Description
A complete, all-in-one guide to the Level 4 Certificate in Education and Training, suitable for use with any awarding organisation. This is a fully updated third edition of the essential text for all those working towards the Level 4 Certificate in Education and Training. Tailored to meet the demands of the qualification and the latest Standards, it provides full coverage of all the mandatory units plus additional information on reflective practice, study skills, and mental well-being. It also includes new case studies throughout and an increased emphasis on both physical and virtual learning environments and approaches in all chapters. Accessible language is combined with a critical approach that clearly relates practical examples to the required underpinning theory.
Author: Lynn Machin Publisher: Critical Publishing ISBN: 1913063399 Category : Education Languages : en Pages : 306
Book Description
This is a new, third edition of the essential text for all those working towards the Level 5 Diploma in Education and Training. Tailored to meet the demands of the qualification and the latest Standards, it incorporates key information on reflective practice, study and research skills, and provides full coverage of all the mandatory units. Accessible language is combined with a critical approach that clearly relates practical examples to the required underpinning theory. This third edition: has been fully updated throughout, including reference to the new Ofsted Inspection Handbook and legislation around GDPR, mental health, social media and apprenticeships includes new case studies and questions in every chapter features a completely new chapter on mental and emotional well-being is suitable for use with all awarding organisations and HEIs provides the depth and criticality to meet level 5 requirements
Author: Robert F. Smallwood Publisher: John Wiley & Sons ISBN: 1118421019 Category : Business & Economics Languages : en Pages : 464
Book Description
Proven and emerging strategies for addressing document and records management risk within the framework of information governance principles and best practices Information Governance (IG) is a rapidly emerging "super discipline" and is now being applied to electronic document and records management, email, social media, cloud computing, mobile computing, and, in fact, the management and output of information organization-wide. IG leverages information technologies to enforce policies, procedures and controls to manage information risk in compliance with legal and litigation demands, external regulatory requirements, and internal governance objectives. Information Governance: Concepts, Strategies, and Best Practices reveals how, and why, to utilize IG and leverage information technologies to control, monitor, and enforce information access and security policies. Written by one of the most recognized and published experts on information governance, including specialization in e-document security and electronic records management Provides big picture guidance on the imperative for information governance and best practice guidance on electronic document and records management Crucial advice and insights for compliance and risk managers, operations managers, corporate counsel, corporate records managers, legal administrators, information technology managers, archivists, knowledge managers, and information governance professionals IG sets the policies that control and manage the use of organizational information, including social media, mobile computing, cloud computing, email, instant messaging, and the use of e-documents and records. This extends to e-discovery planning and preparation. Information Governance: Concepts, Strategies, and Best Practices provides step-by-step guidance for developing information governance strategies and practices to manage risk in the use of electronic business documents and records.
Author: Alan Rushton Publisher: Kogan Page Publishers ISBN: 9780749433659 Category : Business & Economics Languages : en Pages : 612
Book Description
Designed for students, young managers and seasoned practitioners alike, this handbook explains the nuts and bolts of the modern logistics and distribution world in plain language. Illustrated throughout, this second edition includes new chapters on areas previously not covered, such as: intermodal transport; benchmarking; environmental matters; and vehicle and depot security.
Author: Esther Cameron Publisher: Kogan Page Publishers ISBN: 0749496983 Category : Business & Economics Languages : en Pages : 545
Book Description
This definitive, bestselling text in the field of change management provides comprehensive guidance of everything needed to successfully navigate times of change. Making Sense of Change Management provides a thorough and accessible overview for students and practitioners alike. Without relying on assumed knowledge, it comprehensively covers the theories and models of change management and connects them to workable approaches and techniques that organizations of all types and sizes can use to adapt to tough market conditions and succeed by changing their strategies, structures, mindsets, leadership behaviours and expectations of staff and managers. This completely revised and updated fifth edition contains new chapters on digital transformation and becoming a sustainable business, new material on resilience, well-being and effective leadership, and new examples from organizations including Google, Burberry and Volvo. Supported by "food for thought" and "stop and think" features to aid critical thinking and understanding, as well as checklists, tips and helpful summaries, Making Sense of Change Management remains essential reading for anyone who is currently part of, or leading, a change initiative. New and updated accompanying online resources include international case study question packs for lecturers and lecture slides with reflective questions.
Author: Esther Cameron Publisher: Kogan Page Publishers ISBN: 0749472596 Category : Business & Economics Languages : en Pages : 464
Book Description
The definitive, bestselling text in the field of change management, Making Sense of Change Management provides a thorough overview of the subject for both students and professionals. Along with explaining the theory of change management, it comprehensively covers the models, tools, and techniques of successful change management so organizations can adapt to tough market conditions and succeed by changing their strategies, structures, boundaries, mindsets, leadership behaviours and of course their expectations of the people who work within them. This completely revised and updated 4th edition of Making Sense of Change Management includes more international examples and case studies, emerging new thinking and practice in the area of cultural change and a new chapter on the interrelationship with project management (PM) and change management. It also covers complexity models, agile approaches, and stakeholder management along with cultural sensitivity and what to do when cultures collide. Making Sense of Change Management remains essential reading for anyone who is currently part of, or leading, a change initiative. Online supporting resources include lecture slides, making this an ideal textbook for MBA or graduate students focusing on leading or managing change.
Author: Joseph Brady Publisher: Business Expert Press ISBN: 1948580977 Category : Business & Economics Languages : en Pages : 144
Book Description
The book defines and helps provide key solutions for some of the greatest leadership challenges facing global managers today. Leadership Through the Screen is a business leadership guidebook that tells a story. Written in an easy-to-read manner, each chapter highlights a single issue through the eyes of a fictional VP of marketing. The authors have done the research and included it in these pages so that business leaders do not have to. This book is meant to serve as a map to help modern managers weave their way through many of the fundamental challenges of leading people in a global and virtual realm. It provides the tools, knowledge, and potential solutions these leaders can use to forge successful and productive virtual teams.
Author: Jane Beckett-Camarata Publisher: Emerald Group Publishing ISBN: 183909656X Category : Political Science Languages : en Pages : 280
Book Description
Through the introduction of a new lens through which to view infrastructure finance policy, this book analyses the role of Public Private Partnerships within the context of long-term capital investment and improvement planning, and as a critical aspect of effective long-term capital infrastructure finance policy.
Author: Pramod M. Lad
Author: Pramod M. Lad
Author: Elizabeth A. Bankert
Author: Lynn Machin
Author: Lynn Machin
Author: Robert F. Smallwood
Author: Alan Rushton
Author: Esther Cameron
Author: Esther Cameron
Author: Joseph Brady
Author: Jane Beckett-Camarata