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