Clinical Research: From Proposal to Implementation

Clinical Research: From Proposal to Implementation......Page 1
Half Title Page......Page 3
Title Page......Page 5
Copyright Page......Page 6
Dedication......Page 7
PREFACE......Page 8
CONTENTS......Page 9
CONTRIBUTING AUTHORS......Page 14
FINDING AND PROTECTING TIME TO CONDUCT CLINICAL RESEARCH......Page 17
WORK CLOSELY WITH MENTORS......Page 19
Roles of the Mentor and the Mentee......Page 20
Learning from the Research Team......Page 21
PUBLISHING YOUR RESULTS......Page 22
INTRODUCTION......Page 24
WHAT DOES THE IRB DO?......Page 25
WHAT DOES THE IRB NEED TO REVIEW?: FOUR KEY POINTS......Page 26
Full-Board Review......Page 27
THE IRB REVIEW......Page 28
Drugs, Devices, and Biologics......Page 31
Certificates of Confidentiality......Page 32
Recruitment......Page 33
Adverse Events and Unanticipated Problems......Page 35
Deviations and Violations......Page 36
Continuing Review......Page 37
POSTAPPROVAL MONITORING......Page 38
CLOSING A PROTOCOL......Page 39
CONCLUSIONS......Page 40
INTRODUCTION......Page 41
BELMONT COMMISSION......Page 43
CODE OF FEDERAL REGULATIONS......Page 44
Required Element 1—The Research Declaration......Page 46
Required Element 6—Compensation......Page 47
GUIDELINES FOR PREPARING CONSENT FORMS AND ASSURING AN EFFECTIVE AND VALID CONSENTING PROCESS......Page 48
WHAT ACTIVITIES ARE SUBJECT TO IRB REVIEW?......Page 50
WAIVERS AND ALTERATIONS OF INFORMED CONSENT......Page 51
NON-ENGLISH-SPEAKING SUBJECTS AND TRANSLATION OF CONSENT DOCUMENTS......Page 53
HIPAA AUTHORIZATION AND WAIVER OF AUTHORIZATIONS......Page 54
HIPAA WAIVER OF AUTHORIZATION......Page 55
THE PROCESS OF OBTAINING INFORMED CONSENT......Page 56
INTRODUCTION......Page 57
NIH Data Sharing Policy......Page 58
HIPAA Privacy Rule and Data Sharing......Page 59
REIDENTIFICATION MODELS, METHODS, AND APPLICATIONS......Page 60
Risk of Identification......Page 61
Genotype–Phenotype......Page 62
Genome Sequence Data......Page 63
OBSERVATIONS......Page 64
RECOMMENDATIONS AND FUTURE DIRECTIONS......Page 66
CONCLUSIONS......Page 70
INTRODUCTION......Page 73
GETTING STARTED ON THE STATISTICAL ANALYSIS PLAN......Page 74
Sampling......Page 76
What Information is Needed to Calculate Power and Sample Size?......Page 77
Effect Size......Page 78
Variation Estimates for Sample Size Calculations......Page 79
Do All Studies Need Sample Size and Power Estimates?......Page 80
STATISTICAL ANALYSIS METHODOLOGY......Page 81
Analysis Data Sets......Page 82
Interim Analysis......Page 83
Matching in Case–Control Studies......Page 84
DISCUSSION......Page 85
CONCLUSION......Page 86
INTRODUCTION......Page 88
FUNDING......Page 89
RESOURCES......Page 90
REGULATORY APPROVAL......Page 91
SUMMARY......Page 92
Identify Clinic Space Needs......Page 93
Time Allocation......Page 94
SCREENING AND EVALUATION VISIT: 10 STEPS......Page 95
PROTOCOL-SPECIFIC REQUIREMENTS......Page 97
SCREEN FAILURES......Page 98
Source Documentation......Page 99
Screening and Evaluation Study Forms......Page 100
INTRODUCTION......Page 102
The Disease or Condition......Page 103
Study Duration......Page 104
Resources......Page 105
Training......Page 106
Study Coordinator......Page 107
Communication Cycle......Page 108
Retention Tools......Page 110
Examples of Retention Tools......Page 111
SUMMARY......Page 112
INTRODUCTION......Page 113
Describe Data Elements to be Collected......Page 114
Design the Forms......Page 116
Other Design Considerations......Page 118
DATABASE SELECTION AND DESIGN......Page 121
Database Organization......Page 122
QUALITY CONTROL IN DATA CAPTURE......Page 125
THE IMPORTANCE OF AN AUDIT TRAIL......Page 126
DATA CLEANING AND LOCK......Page 127
SUMMARY......Page 128
CHAPTER 10: Budgeting Process and Management......Page 129
NIH Cooperative Group Protocols......Page 130
Preliminary Research......Page 132
Inpatient......Page 133
Investigator’s Time......Page 134
Capital Equipment......Page 135
Postage......Page 136
Facilities and Administration (F&A) Fees......Page 137
Travel......Page 138
Study Drugs and Devices......Page 139
Laboratory......Page 141
Cardiology......Page 142
Ancillary Costs......Page 143
Upfront Payment......Page 144
Final Payment......Page 145
Leveraging Resources......Page 146
INTRODUCTION......Page 148
THE REGULATORY ENVIRONMENT AND FDA ROLE......Page 149
WHEN IS AN IND NOT NEEDED FOR STUDIES INVOLVING MARKETED DRUGS?......Page 152
INVESTIGATIONAL NEW DRUG APPLICATION......Page 153
IND GUIDANCE AND PLANNING......Page 154
FDA FORM 1571......Page 155
FDA FORM 3674......Page 156
SUBMITTING AN IND......Page 157
RESPONDING TO A CLINICAL HOLD......Page 158
Safety Reports (21 CFR 312.32)......Page 159
MONITORING RESPONSIBILITIES FOR SPONSOR-INVESTIGATORS......Page 160
CONCLUSION......Page 161
Definitions......Page 163
Obtaining Preliminary Data......Page 164
The HIPAA Waiver or “What You Can Get Without Getting Consent”......Page 166
Blood and Tissue Banking/Repositories......Page 167
Study Visits and Research-Related Activities......Page 170
Source Documents......Page 172
The Source File......Page 173
Special Topics......Page 174
Consistency......Page 175
DATA PROTECTION......Page 176
Certificate of Confidentiality......Page 177
What Is a Data and Safety Monitoring Plan (DSMP)?......Page 179
Who Is Responsible for Data and Safety Monitoring?......Page 180
Do All Studies Require a DSMP?......Page 181
WHAT ARE APPROPRIATE MONITORING ENTITIES & METHODS?......Page 182
Data Safety Monitoring Board (DSMB)/Data Safety Monitoring Committee (DSMC)/Data Monitoring Committee (DMC)......Page 183
The Role of the Institutional Review Board (IRB) in the Review and Approval of DSMPs?......Page 185
CONCLUSIONS......Page 186
Articulate Writing Is Critical to Scientific Success......Page 187
Getting Started......Page 188
Tell the Story......Page 189
Be Pithy......Page 190
Abstract......Page 191
Methods......Page 192
Results......Page 194
Discussion......Page 195
Acknowledgments......Page 196
Authorship......Page 197
Choosing a Journal......Page 198
Rejections and Resubmissions......Page 199
CONCLUSION......Page 200
Why is this study being done?......Page 201
Why am I being asked to take part in this research study?......Page 202
What is involved in the study?......Page 203
What are the risks of the study?......Page 205
What will my responsibilities be during the study?......Page 209
Will I be paid if I take part in this research study?......Page 210
Will my insurance provider or I be charged for the costs of any part of this research study?......Page 211
Will my information be kept confidential?......Page 212
Whom do I call if I have questions or problems?......Page 214
APPENDIX B: Documentation of Informed Consent......Page 216
Does the form contain details (or space) for the following content?......Page 217
CONSENT TO PARTICIPATE IN RESEARCH......Page 219
What will happen if I am harmed as a result of taking part in this study?......Page 227
Is there anything else I should know before I decide?......Page 228
Who will be able to use or share my health information?......Page 230
Why is my personal contact information being used?......Page 231
Will I receive a copy of this authorization?......Page 232
Instructions......Page 234
Why am I being asked to take part in this research study?......Page 235
What is involved in the study?......Page 236
What are the risks of the study?......Page 238
What will my responsibilities be during the study?......Page 242
Will I be paid if I take part in this research study?......Page 243
Will my insurance provider or I be charged for the costs of any part of this research study?......Page 244
Will my information be kept confidential?......Page 245
Will my health information be used for other purposes?......Page 247
Whom do I call if I have questions or problems?......Page 248
SEE INSTRUCTION PAGE FOR GUIDANCE AND EXAMPLES......Page 250
Personnel......Page 252
Supplies......Page 253
Consortium/Contractual costs......Page 254
ADVERSE EVENTS......Page 256
NOTES......Page 257
Person(s) responsible for data monitoring......Page 258
Stopping rules......Page 259
INDEX......Page 260