Clinical Research: From Proposal to Implementation

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Wydawca: Wolters Kluwer Health

ISBN: 9781605477480

390,60 zł

351,54 zł Zniżka 39,06 zł Brutto

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Opis

Clinical Research:: From Proposal to Implementation will serve as a road map for students and junior researchers seeking to successfully design, implement, and publicize the results of clinical research. The book covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. It familiarizes readers with the regulatory aspects of human research and the procedures involved in investigational new drug and device applications. The authors provide a working knowledge of how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on the collection, quality control, and analysis of research data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine s Research Tools and Issues feature.

Szczegóły produktu

Wydawca Wolters Kluwer Health

Indeks 47413

EAN13 9781605477480

ISBN 9781605477480

Opis

Rok wydania: 2010
Numer wydania: 1
Oprawa: miękka foliowana
Liczba stron: 256
Wymiary (mm): 152.40 x 228.60
Waga (g): 295

Dedication v Preface vi Contributing Authors xii CHAPTER 1 How to Launch a Successful Career in Clinical Research: Tips on Making the Most of Available Resources 1 Robert D. Toto, MD Introduction 1 Finding and Protecting Time to Conduct Clinical Research 1 Work Closely with Mentors 3 Publishing Your Results 6 CHAPTER 2 Institutional Review Board Approval 8 Suzanne M. Rivera, PhD Introduction 8 What is an IRB? 9 What Does the IRB Do? 9 What Does the IRB Need to Review?: Four Key Points 10 Levels of IRB Review 11 Applying for IRB Review 12 The IRB Review 12 Of Special Concern to IRBs 15 Common Reasons for IRB Delays 17 Postapproval Monitoring 22 Closing a Protocol 23 Conclusions 24 CHAPTER 3 Writing Informed Consent Documents and Obtaining Informed Consent 25 Anne Clark, CIP, Suzanne M. Rivera, PhD, MSW, P. Diane Sheppard, RN, Darren K. McGuire, MD, MHSc, and Michael J. McPhaul, MD Introduction 25 Belmont Commission 27 Code of Federal Regulations 28 Required Elements 30 Additional Elements 32 Guidelines for Preparing Consent Forms and Assuring an Effective and Valid Consenting Process 32 Documentation of Informed Consent 34 What Activities Are Subject to IRB Review? 34 Waivers and Alterations of Informed Consent 35 Waiver of Documentation of Informed Consent (Verbal Consent) 37 Non-English-Speaking Subjects and Translation of Consent Documents 37 DNA and Unused Samples 38 HIPAA Authorization and Waiver of Authorizations 38 HIPAA Waiver of Authorization 39 The Process of Obtaining Informed Consent 40 CHAPTER 4 Ethics of Data Sharing and Handling of Genetic Information 41 Bradley A. Malin, PhD, David Karp, MD, PhD, and Richard H. Scheuermann, PhD Introduction 41 Policies and Requirements 42 Reidentification Models, Methods, and Applications 44 Observations 48 Recommendations and Future Directions 50 Conclusions 54 CHAPTER 5 Writing a Statistical Analysis Plan 57 Beverley Adams-Huet, MS and Chul Ahn, PhD Introduction 57 Getting Started on the Statistical Analysis Plan 58 Study Design 60 Statistical Analysis Methodology 65 Overlooked Areas 68 Discussion 69 Conclusion 70 CHAPTER 6 Protocol Implementation Procedures 72 Tammy L. Lightfoot, RN, BSN Introduction 72 Protocol Implementation Preparation 73 Funding 73 Resources 74 Staff Training 75 Regulatory Approval 75 The Investigatorżs Responsibilities 76 Summary 76 CHAPTER 7 Screening and Evaluation 77 Robert D. Toto, MD Introduction 77 Infrastructure 77 Advertising 78 Operations 78 Screening and Evaluation Visit: 10 Steps 79 Protocol-Specific Requirements 81 Special Tests 82 Screen Failures 82 Documentation 83 CHAPTER 8 Recruitment and Retention 86 Tammy L. Lightfoot, RN, BSN Introduction 86 When Should Recruitment and Retention Start? 87 Building a Clinical Research Team 90 Summary 96 CHAPTER 9 How to Set up Your Database 97 Janet P. Smith, BA Introduction 97 Data Definition and Forms Design 98 Data Collection and Management Plan 105 Database Selection and Design 105 Quality Control in Data Capture 109 Databases and Security 110 The Importance of an Audit Trail 110 Data Cleaning and Lock 111 Summary 112 CHAPTER 10 Budgeting Process and Management 113 Deanna S. Adams, RN Introduction 114 The Funding Source 114 Preliminary Costs 116 SHORTENED TO FIT SPACE

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