Clinical research law and compliance handbook:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Sudbury, Mass. [u.a.]
Jones and Bartlett
c2006
|
| Schlagworte: | |
| Online-Zugang: | Table of contents Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XXX, 460 S. |
| ISBN: | 0763747254 |
Internformat
MARC
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| 245 | 1 | 0 | |a Clinical research law and compliance handbook |c ed. by John E. Steiner, Jr |
| 264 | 1 | |a Sudbury, Mass. [u.a.] |b Jones and Bartlett |c c2006 | |
| 300 | |a XXX, 460 S. | ||
| 336 | |b txt |2 rdacontent | ||
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| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Clinical trials |x Law and legislation |z United States | |
| 650 | 4 | |a Medicine |x Research |x Law and legislation |z United States | |
| 651 | 4 | |a USA | |
| 700 | 1 | |a Steiner, John E. |e Sonstige |4 oth | |
| 856 | 4 | |u http://www.loc.gov/catdir/toc/ecip0510/2005008613.html |3 Table of contents | |
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Datensatz im Suchindex
| _version_ | 1804135277306839040 |
|---|---|
| adam_text | CONTENTS
CHAPTER ONE
Key Compliance Issues for Academic Medical
Organizations 1
Joan Booth and Katherine Hammerhofer
Introduction 1
Operational Interventions to Enhance Compliance 5
Resources 43
Notes and References 57
CHAPTER TWO
Contract Issues in Clinical Trials 59
Donna f. Meyer
Role of the Research Contract 59
Key Issues in Private Research Contracts 62
Regulation of Health Care Transactions 67
Other Financial Relationships in Sponsored Research 70
Avoiding Private Benefit for Use of
Public Resources in Sponsored Research 74
Defining Publication Rights 76
Conclusion 79
Notes and References 80
iii
^^m Contents
CHAPTER THREE
Clinical Research Billing: Process and Monitoring Issues 107
John E. Steiner, Jr and F. Lisa Murtha
Introduction 107
Clinical Research Billing Process Issues 108
Clinical Trial Monitoring Issues 119
Notes and References 121
Appendix A 122
Appendix B 125
CHAPTER FOUR
Clinical Research Trials: Operational and Budget Issues 145
Bill Hunt and Sue O Connell
Control Mechanisms 146
Budget Preparation 151
Negotiating Services with a Sponsor 164
Research Charging Operations 165
CHAPTER FIVE
Fraud and Abuse in Clinical Research 169
Karen Owen Dunlop, William A. Sarraille, and Bryan Lee
Introduction 169
The Antikickback Statute 171
Administrative Guidance 174
Industry Guidance 178
Application of Antikickback Principles to Clinical Research 182
False Claims Act 185
Certifications and FCA Liability 186
Industry Guidance 196
Arrangements Prosecuted Under the FCA 198
Future Enforcement Areas 205
Conclusion 206
Notes and References 207
Contents ^9
CHAPTER SIX
Uses and Disclosures of Identifiable Information in
Clinical Research: National and International
Considerations 221
M. Peter Adler and Jeffrey G. Micklos
Introduction: The Challenge of Protecting Health Information
in the Clinical Trial Process 221
Data Management and Data Hows during Clinical Trials 223
U.S. Privacy Protections Affecting the Clinical Trial Process 226
Canadian Law 238
European Law 243
The Data Transfer Agreement 251
The De identification of Information 252
Unambiguous Informed Consent 253
Unified Approach to Compliance 256
Notes and References 259
CHAPTER SEVEN
Identifying Applicable Laws and Reducing Key Risks
in Nonregistrational, Postmarketing Studies 265
Judith E. Beach and Nancy Strehlow
Introduction 265
The Increasing Need for Nonregistrational, Postmarketing Studies 266
Key Laws and Regulations Applicable to Nonregistrational,
Postmarketing Studies 267
Laws and Regulations That Generally Do Not Apply to Nonregistrational,
Postmarketing Studies 268
The Antikickback Statute 269
The False Claims Act 280
Debarment 286
Reporting Postmarketing Adverse Drug Experiences and
Unanticipated Adverse Device Effects 287
Health Insurance Portability and Accountability Act 287
The Common Rule 288
^^M Contents
Federal Acquisition Regulations 290
Promotion and Charging for Investigational Medical Products 290
Food and Drug Administration Modernization Act (FDAMA) 290
21 CFR Part 50 (Informed Consent) 291
Disqualification 291
ICH GCP 292
21 CFR Part 56 (IRB Review) 292
Laws and Regulations That Generally Do Not Apply to Nonregistrational,
Postmarketing Studies 293
Conclusion 296
Glossary of Terms 296
Additional Resources 297
Notes and References 297
CHAPTER EIGHT
Key Compliance Issues for Institutional Review Boards 299
Michael J. Meehan and Marleina Thomas Davis
Introduction 299
Research Review Process 300
Is It Really Research? 300
Initial Review 302
Continuing Review 305
Expedited Review 306
Exempt Research 308
The Investigators 309
Adverse Events and Unanticipated Problems 310
Obtaining Consent 310
IRB Staff, Policies, and Records 316
Privacy 319
Conflicts of Interest 328
Conclusion 329
Notes and References 330
Contents ^ffl
CHAPTER NINE
Conflicts of Interest in Biomedical Research—Avoiding Bias 335
Kendra Dimond and Joseph B. Clamon
Introduction 335
Transformation of Biomedical Research: Increase in
Academic Government Industry Collaboration 336
Conflicts of Interest: A Threat to Collaboration 338
Conclusion 355
Notes and References 355
CHAPTER TEN
Enhancing Data Quality and Patient Safety through
the Use of Technology in Clinical Trials 361
Jeffrey A. Green and Marc Shlaes
Introduction: Inevitable Advancement of Technology Use in Clinical Trials 361
Quantifying the Value Proposition—What Is at Stake? 362
It s All about Process 364
Steps to Success with Global EDC Implementations 365
EDC and Patient Safety in Clinical Trials 368
Current Status 372
The Clinical Care Parallel—Accentuating Timeliness 374
The EKG Parallel—Accentuating Accuracy 375
The Governmental Parallel—Accentuating Universality 376
Critic s Corner on Safety Concerns 377
What Is Needed? 381
Conclusion 382
Notes and References 383
|
| adam_txt |
CONTENTS
CHAPTER ONE
Key Compliance Issues for Academic Medical
Organizations 1
Joan Booth and Katherine Hammerhofer
Introduction 1
Operational Interventions to Enhance Compliance 5
Resources 43
Notes and References 57
CHAPTER TWO
Contract Issues in Clinical Trials 59
Donna f. Meyer
Role of the Research Contract 59
Key Issues in Private Research Contracts 62
Regulation of Health Care Transactions 67
Other Financial Relationships in Sponsored Research 70
Avoiding Private Benefit for Use of
Public Resources in Sponsored Research 74
Defining Publication Rights 76
Conclusion 79
Notes and References 80
iii
^^m Contents
CHAPTER THREE
Clinical Research Billing: Process and Monitoring Issues 107
John E. Steiner, Jr and F. Lisa Murtha
Introduction 107
Clinical Research Billing Process Issues 108
Clinical Trial Monitoring Issues 119
Notes and References 121
Appendix A 122
Appendix B 125
CHAPTER FOUR
Clinical Research Trials: Operational and Budget Issues 145
Bill Hunt and Sue O'Connell
Control Mechanisms 146
Budget Preparation 151
Negotiating Services with a Sponsor 164
Research Charging Operations 165
CHAPTER FIVE
Fraud and Abuse in Clinical Research 169
Karen Owen Dunlop, William A. Sarraille, and Bryan Lee
Introduction 169
The Antikickback Statute 171
Administrative Guidance 174
Industry Guidance 178
Application of Antikickback Principles to Clinical Research 182
False Claims Act 185
Certifications and FCA Liability 186
Industry Guidance 196
Arrangements Prosecuted Under the FCA 198
Future Enforcement Areas 205
Conclusion 206
Notes and References 207
Contents ^9
CHAPTER SIX
Uses and Disclosures of Identifiable Information in
Clinical Research: National and International
Considerations 221
M. Peter Adler and Jeffrey G. Micklos
Introduction: The Challenge of Protecting Health Information
in the Clinical Trial Process 221
Data Management and Data Hows during Clinical Trials 223
U.S. Privacy Protections Affecting the Clinical Trial Process 226
Canadian Law 238
European Law 243
The Data Transfer Agreement 251
The De identification of Information 252
Unambiguous Informed Consent 253
Unified Approach to Compliance 256
Notes and References 259
CHAPTER SEVEN
Identifying Applicable Laws and Reducing Key Risks
in Nonregistrational, Postmarketing Studies 265
Judith E. Beach and Nancy Strehlow
Introduction 265
The Increasing Need for Nonregistrational, Postmarketing Studies 266
Key Laws and Regulations Applicable to Nonregistrational,
Postmarketing Studies 267
Laws and Regulations That Generally Do Not Apply to Nonregistrational,
Postmarketing Studies 268
The Antikickback Statute 269
The False Claims Act 280
Debarment 286
Reporting Postmarketing Adverse Drug Experiences and
Unanticipated Adverse Device Effects 287
Health Insurance Portability and Accountability Act 287
The Common Rule 288
^^M Contents
Federal Acquisition Regulations 290
Promotion and Charging for Investigational Medical Products 290
Food and Drug Administration Modernization Act (FDAMA) 290
21 CFR Part 50 (Informed Consent) 291
Disqualification 291
ICH GCP 292
21 CFR Part 56 (IRB Review) 292
Laws and Regulations That Generally Do Not Apply to Nonregistrational,
Postmarketing Studies 293
Conclusion 296
Glossary of Terms 296
Additional Resources 297
Notes and References 297
CHAPTER EIGHT
Key Compliance Issues for Institutional Review Boards 299
Michael J. Meehan and Marleina Thomas Davis
Introduction 299
Research Review Process 300
Is It Really Research? 300
Initial Review 302
Continuing Review 305
Expedited Review 306
Exempt Research 308
The Investigators 309
Adverse Events and Unanticipated Problems 310
Obtaining Consent 310
IRB Staff, Policies, and Records 316
Privacy 319
Conflicts of Interest 328
Conclusion 329
Notes and References 330
Contents ^ffl
CHAPTER NINE
Conflicts of Interest in Biomedical Research—Avoiding Bias 335
Kendra Dimond and Joseph B. Clamon
Introduction 335
Transformation of Biomedical Research: Increase in
Academic Government Industry Collaboration 336
Conflicts of Interest: A Threat to Collaboration 338
Conclusion 355
Notes and References 355
CHAPTER TEN
Enhancing Data Quality and Patient Safety through
the Use of Technology in Clinical Trials 361
Jeffrey A. Green and Marc Shlaes
Introduction: Inevitable Advancement of Technology Use in Clinical Trials 361
Quantifying the Value Proposition—What Is at Stake? 362
It's All about Process 364
Steps to Success with Global EDC Implementations 365
EDC and Patient Safety in Clinical Trials 368
Current Status 372
The Clinical Care Parallel—Accentuating Timeliness 374
The EKG Parallel—Accentuating Accuracy 375
The Governmental Parallel—Accentuating Universality 376
Critic's Corner on Safety Concerns 377
What Is Needed? 381
Conclusion 382
Notes and References 383 |
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| spellingShingle | Clinical research law and compliance handbook Medizin Recht Clinical trials Law and legislation United States Medicine Research Law and legislation United States |
| title | Clinical research law and compliance handbook |
| title_auth | Clinical research law and compliance handbook |
| title_exact_search | Clinical research law and compliance handbook |
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| title_full | Clinical research law and compliance handbook ed. by John E. Steiner, Jr |
| title_fullStr | Clinical research law and compliance handbook ed. by John E. Steiner, Jr |
| title_full_unstemmed | Clinical research law and compliance handbook ed. by John E. Steiner, Jr |
| title_short | Clinical research law and compliance handbook |
| title_sort | clinical research law and compliance handbook |
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