The Cras Guide to Monitoring Clinical Research

Karen E. Woodin, Ph.D., is a consultant/trainer to the pharmaceutical industry in the areas of clinical operations, GCPs, SOPs, IRBs and site monitoring. She is actively involved in DIA, serving as faculty/chairperson for the CRA training course, as well as chairing workshops relevant to clinical trial management activities John C. Schneider is a consultant/trainer to the pharmaceutical industry in the areas of GCPs, SOPs and site monitoring. He has taught DIA's Entry Level CRA Course for several years, in addition to conducting numerous tutorials during the DIA Annual Meeting

What Is a CRA?	p. 13
The CRA--An Overview	p. 13
The CRA Personality	p. 15
CRA Tasks	p. 17
Career Preparation	p. 18
In the Future	p. 21
Your Value	p. 21
The History Behind the Regulations	p. 23
Regulation and Human Subject Protection Milestones	p. 24
Summary	p. 30
The Research Process	p. 32
Pre-clinical Research	p. 32
The IND (Investigational New Drug) Application	p. 37
Clinical Trials	p. 39
Summary	p. 45
Regulations and GCPs	p. 47
FDA Regulations for Clinical Trials	p. 48
ICH Guidelines for Good Clinical Practice	p. 48
FDA Guidelines and Information Sheets	p. 49
FDA Compliance Program Guidance Manuals	p. 49
NIH-Regulated Research	p. 50
FDA Bioresearch Monitoring Program (BIMO)	p. 50
Good Clinical Practice (GCP)	p. 51
Contacting the FDA	p. 51
Institutional Review Boards	p. 54
Types of IRBs	p. 55
IRB responsibilities	p. 56
IRB review of proposed research	p. 59
IRB Membership	p. 62
IRB Operations	p. 62
Conflict of Interest	p. 63
Informed Consent	p. 64
Monitoring Informed Consent	p. 65
Basic Elements of Consent	p. 66
Obtaining Informed Consent	p. 68
The Consent Process	p. 69
Exceptions from consent	p. 70
Conclusion	p. 73
Preparing for a Study	p. 74
Study Design	p. 74
Developing a Protocol	p. 82
Case Report Forms (CRFs)	p. 91
Clinical Investigators	p. 100
Investigators and Their Responsibilities	p. 100
Evaluating and Selecting Investigators	p. 104
Locating Potential Investigators	p. 106
Study Initiation	p. 114
Study Initiation Documents	p. 114
Financial Disclosure	p. 115
The Investigator Meeting	p. 117
Study Initiation Meetings	p. 125
Investigator Study Files	p. 128
Grants and Contracts	p. 130
Study Monitoring	p. 136
The Game Plan for Monitoring	p. 136
Preparing for a Monitoring Visit	p. 140
Site monitoring visits	p. 142
Confidentiality	p. 155
The End of the Visit	p. 156
Monitoring Visit Reports	p. 157
Conclusion	p. 158
Adverse Events and Safety Monitoring	p. 161
Regulations	p. 161
Adverse Events (AEs) on Marketed Products	p. 164
Adverse Events (AEs) in Clinical Trials	p. 165
Investigator Reporting Responsibilities	p. 168
Sponsor Responsibilities	p. 169
Differences Between Clinical Studies and Clinical Practice	p. 169
Common reporting problems	p. 172
Recruitment, Retention and Compliance	p. 174
Recruitment of Study Subjects	p. 174
Retention of Study Subjects	p. 185
Subject Compliance	p. 190
Study Closeout	p. 197
Reasons for study closeout	p. 197
Closeout procedures	p. 199
Audits	p. 203
Sponsor audits of investigative sites	p. 203
IRB audits of investigative sites	p. 206
FDA audits	p. 206
Errors, Misconduct and Fraud	p. 215
Definitions	p. 215
Errors	p. 216
Misconduct	p. 218
Fraud	p. 220
Conclusion	p. 226
Afterword	p. 227
Resources	p. 228
Hints and Tips	p. 233
Sample Forms, Checklists and Logs	p. 244
Job Descriptions and Academic Programs	p. 268
ICH-FDA Comparison	p. 276
Harmonized Tripartite Guidelines for Good Clinical Practice	p. 280
Code of Federal Regulations	p. 333
21 CRR 50	p. 333
21 CFR 54	p. 353
21 CFR 56	p. 359
21 CFR 312	p. 375
FDA Form 1572	p. 439
About CenterWatch	p. 441
About the Authors	p. 447
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