Clinical Research: From Proposal to Implementation Book

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 Investigator¿s 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

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