Clinical Research Law and Compliance HandbookJohn E. Steiner The purpose of the anthology is to provide timely, practical analysis and advice for people engaged in clinical research trials to advance medical knowledge and its application, for those who support such efforts, and for participants in clinical trials. Contributors from both law and medicine consider such aspects as contract issues, process and m |
Contents
CHAPTER | 1 |
Resources | 14 |
Notes and References | 57 |
Regulation of Health Care Transactions | 67 |
Avoiding Private Benefit for Use | 74 |
Notes and References | 80 |
CHAPTER THREE | 107 |
Notes and References | 121 |
Debarment | 286 |
Federal Acquisition Regulations | 290 |
Conclusion | 296 |
Initial Review | 302 |
Exempt Research | 308 |
IRB Staff Policies and Records | 316 |
Conflicts of Interest | 328 |
CHAPTER NINE | 335 |
CHAPTER FOUR | 145 |
Negotiating Services with a Sponsor | 164 |
Industry Guidance | 178 |
Industry Guidance | 196 |
CHAPTER | 221 |
Canadian Law | 238 |
The Data Transfer Agreement | 251 |
Notes and References | 259 |
CHAPTER SEVEN | 265 |
The False Claims Act | 280 |
Conclusion | 355 |
CHAPTER | 361 |
EDC and Patient Safety in Clinical Trials | 368 |
The Clinical Care ParallelAccentuating Timeliness | 374 |
What Is Needed? | 381 |
CHAPTER ELEVEN | 385 |
Other Regulatory Considerations | 398 |
CHAPTER TWELVE | 411 |
Practical Considerations | 435 |
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Common terms and phrases
adverse event Agreement Antikickback Statute applicable approval audit authorization Belmont Report billing certification charges Cleveland Clinic clinical investigators clinical research trials clinical trial Code compliance comply conduct conflicts of interest contract costs covered entity Data Protection Directive Department device disclose disclosure document drug enrollment ensure False Claims False Claims Act federal financial interests grant guidance guidelines health information HIPAA human subjects ical identify individual informed consent Institutional Review Board involving issues manufacturer Medicare ment monitoring Nuremberg Code obtain OHRP organization participants parties patient payment personal information pharmaceutical physicians PIPEDA policies postmarketing studies potential practice Privacy Rule procedures protocol qui tam regulations regulatory reimbursement research subjects responsible risk safe harbor Safe Harbor Principles specific standard study budget tion violations yes yes yes