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Principles and practice of clinical research [[electronic resource] /] / edited by John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research [[electronic resource] /] / edited by John I. Gallin, Frederick P. Ognibene |
| Edizione | [3rd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 |
| Descrizione fisica | 1 online resource (797 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-283-73518-0
0-12-382168-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Ethical, regulatory and legal issues -- pt. 2. Biostatistics and epidemiology -- pt. 3. Technology transfer, protocol development, and funding -- pt. 4. Clinical research infrastructure. |
| Record Nr. | UNINA-9910461642703321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical research [[electronic resource] /] / edited by John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research [[electronic resource] /] / edited by John I. Gallin, Frederick P. Ognibene |
| Edizione | [3rd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 |
| Descrizione fisica | 1 online resource (797 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| ISBN |
1-283-73518-0
0-12-382168-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Ethical, regulatory and legal issues -- pt. 2. Biostatistics and epidemiology -- pt. 3. Technology transfer, protocol development, and funding -- pt. 4. Clinical research infrastructure. |
| Record Nr. | UNINA-9910790274103321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical research / / edited by John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research / / edited by John I. Gallin, Frederick P. Ognibene |
| Edizione | [3rd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 |
| Descrizione fisica | 1 online resource (797 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| ISBN |
1-283-73518-0
0-12-382168-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Ethical, regulatory and legal issues -- pt. 2. Biostatistics and epidemiology -- pt. 3. Technology transfer, protocol development, and funding -- pt. 4. Clinical research infrastructure. |
| Record Nr. | UNINA-9910816074403321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 |
| Descrizione fisica | 1 online resource (447 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-05227-2
9786611052270 0-08-048956-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front cover; Principles and Practice of Clinical Research; Copyright page; Table of contents; Preface; Acknowledgements; Contributors; Chapter 1: A Historical Perspective on Clinical Research; 1. THE EARLIEST CLINICAL RESEARCH; 2. THE GREEK AND ROMAN INFLUENCE; 3. MIDDLE AGES AND RENAISSANCE; 4. SEVENTEENTH CENTURY; 5. EIGHTEENTH CENTURY; 6. NINETEENTH CENTURY; 7. TWENTIETH CENTURY AND BEYOND; Acknowledgment; References and Notes; PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES; Chapter 2: Ethical Principles in Clinical Research; 1. DISTINGUISHING CLINICAL RESEARCHFROM CLINICAL PRACTICE
2. WHAT DOES ETHICS HAVE TO DOWITH CLINICAL RESEARCH?3. HISTORY OF ETHICAL ATTENTION TOCLINICAL RESEARCH; 4. CODES OF RESEARCH ETHICSAND REGULATIONS; 5. ETHICAL FRAMEWORK FORCLINICAL RESEARCH; 6. ETHICAL CONSIDERATIONS IN RANDOMIZED CLINICAL TRIALS; 7. CONCLUSION; References; Chapter 3: Researching a Bioethical Question; 1. TYPES OF BIOETHICAL ISSUES; 2. TYPES OF BIOETHICAL RESEARCH METHODOLOGIES; 3. EXAMPLES OF IMPORTANT BIOETHICAL RESEARCH; 4. SPECIAL CONSIDERATIONS INBIOETHICAL RESEARCH; References and Notes; Chapter 4: Integrity in Research: Individual and Institutional Responsibility 1. GUIDELINES FOR THE CONDUCTOF RESEARCH2. SCIENTIFIC INTEGRITY AND MISCONDUCT; 3. MENTOR-TRAINEE RELATIONSHIPS; 4. DATA ACQUISITION, MANAGEMENT, SHARING, AND OWNERSHIP; 5. RESEARCH INVOLVING HUMAN AND ANIMAL SUBJECTS; 6. COLLABORATIVE SCIENCE; 7. CONFLICT OF INTEREST AND COMMITMENT; 8. PEER REVIEW; 9. PUBLICATION PRACTICES AND RESPONSIBLE AUTHORSHIP; Acknowledgment; References; Chapter 5: Institutional Review Boards; 1. HISTORICAL, ETHICAL, ANDREGULATORY FOUNDATIONSOF CURRENT REQUIREMENTSFOR RESEARCH INVOLVINGHUMAN SUBJECTS; 2. INSTITUTIONAL REVIEW BOARDS; 3. CLINICAL RESEARCHERSAND IRBs 4. THE CURRENT IRB SYSTEM UNDER EVALUATION5. CONCLUSION; References and Notes; Chapter 6: Data and Safety Monitoring Boards; 1. DESCRIPTION OF THE DATA ANDSAFETY MONITORING BOARD; 2. DATA AND SAFETY MONITORINGBOARD FUNCTIONS; 3. DATA AND SAFETY MONITORINGBOARD DECISION MAKING; 4. EXAMPLES; 5. CONCLUSIONS; References; Chapter 7: Data Management in Clinical Trials; 1. THE RESEARCH TEAM; 2. PLANNING THE TRIAL; 3. WHERE ARE DATA?; 4. WHO CAN COLLECT DATA?; 5. SITE INITIATION VISIT; 6. INFORMED CONSENT; 7. ELIGIBILITY; 8. REGISTRATION; 9. WHAT DATA DO YOU COLLECT?; 10. TREATMENT PLAN 11. CONCURRENT THERAPY12. ADVERSE EVENT MONITORING; 13. ROUTINE MONITORING VISITS; 14. AUDIT TRAIL; 15. ELECTRONIC DATABASE; 16. SUMMARY; References; Chapter 8: Unanticipated Risk in Clinical Research; 1. THE REASONS; 2. THE DRUG; 3. THE TARGET; 4. THE TRIALS; 5. CASSANDRA REVEALED; 6. EXTENDED STUDIES; 7. FIAU TOXICITY; 8. REASSESSING THEPRECLINICAL STUDIES; 9. RESEARCH OVERSIGHT; 10. THE INVESTIGATIONS BEGIN; 11. SCIENTIFIC MISCONDUCT; 12. THE FDA; 13. THE NATIONAL INSTITUTES OF HEALTH; 14. THE INSTITUTE OF MEDICINE; 15. THE MEDIA; 16. THE CONGRESS; 17. THE LAW; 18. EPILOGUE Acknowledgments |
| Record Nr. | UNINA-9910458652203321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 |
| Descrizione fisica | 1 online resource (447 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| ISBN |
1-281-05227-2
9786611052270 0-08-048956-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front cover; Principles and Practice of Clinical Research; Copyright page; Table of contents; Preface; Acknowledgements; Contributors; Chapter 1: A Historical Perspective on Clinical Research; 1. THE EARLIEST CLINICAL RESEARCH; 2. THE GREEK AND ROMAN INFLUENCE; 3. MIDDLE AGES AND RENAISSANCE; 4. SEVENTEENTH CENTURY; 5. EIGHTEENTH CENTURY; 6. NINETEENTH CENTURY; 7. TWENTIETH CENTURY AND BEYOND; Acknowledgment; References and Notes; PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES; Chapter 2: Ethical Principles in Clinical Research; 1. DISTINGUISHING CLINICAL RESEARCHFROM CLINICAL PRACTICE
2. WHAT DOES ETHICS HAVE TO DOWITH CLINICAL RESEARCH?3. HISTORY OF ETHICAL ATTENTION TOCLINICAL RESEARCH; 4. CODES OF RESEARCH ETHICSAND REGULATIONS; 5. ETHICAL FRAMEWORK FORCLINICAL RESEARCH; 6. ETHICAL CONSIDERATIONS IN RANDOMIZED CLINICAL TRIALS; 7. CONCLUSION; References; Chapter 3: Researching a Bioethical Question; 1. TYPES OF BIOETHICAL ISSUES; 2. TYPES OF BIOETHICAL RESEARCH METHODOLOGIES; 3. EXAMPLES OF IMPORTANT BIOETHICAL RESEARCH; 4. SPECIAL CONSIDERATIONS INBIOETHICAL RESEARCH; References and Notes; Chapter 4: Integrity in Research: Individual and Institutional Responsibility 1. GUIDELINES FOR THE CONDUCTOF RESEARCH2. SCIENTIFIC INTEGRITY AND MISCONDUCT; 3. MENTOR-TRAINEE RELATIONSHIPS; 4. DATA ACQUISITION, MANAGEMENT, SHARING, AND OWNERSHIP; 5. RESEARCH INVOLVING HUMAN AND ANIMAL SUBJECTS; 6. COLLABORATIVE SCIENCE; 7. CONFLICT OF INTEREST AND COMMITMENT; 8. PEER REVIEW; 9. PUBLICATION PRACTICES AND RESPONSIBLE AUTHORSHIP; Acknowledgment; References; Chapter 5: Institutional Review Boards; 1. HISTORICAL, ETHICAL, ANDREGULATORY FOUNDATIONSOF CURRENT REQUIREMENTSFOR RESEARCH INVOLVINGHUMAN SUBJECTS; 2. INSTITUTIONAL REVIEW BOARDS; 3. CLINICAL RESEARCHERSAND IRBs 4. THE CURRENT IRB SYSTEM UNDER EVALUATION5. CONCLUSION; References and Notes; Chapter 6: Data and Safety Monitoring Boards; 1. DESCRIPTION OF THE DATA ANDSAFETY MONITORING BOARD; 2. DATA AND SAFETY MONITORINGBOARD FUNCTIONS; 3. DATA AND SAFETY MONITORINGBOARD DECISION MAKING; 4. EXAMPLES; 5. CONCLUSIONS; References; Chapter 7: Data Management in Clinical Trials; 1. THE RESEARCH TEAM; 2. PLANNING THE TRIAL; 3. WHERE ARE DATA?; 4. WHO CAN COLLECT DATA?; 5. SITE INITIATION VISIT; 6. INFORMED CONSENT; 7. ELIGIBILITY; 8. REGISTRATION; 9. WHAT DATA DO YOU COLLECT?; 10. TREATMENT PLAN 11. CONCURRENT THERAPY12. ADVERSE EVENT MONITORING; 13. ROUTINE MONITORING VISITS; 14. AUDIT TRAIL; 15. ELECTRONIC DATABASE; 16. SUMMARY; References; Chapter 8: Unanticipated Risk in Clinical Research; 1. THE REASONS; 2. THE DRUG; 3. THE TARGET; 4. THE TRIALS; 5. CASSANDRA REVEALED; 6. EXTENDED STUDIES; 7. FIAU TOXICITY; 8. REASSESSING THEPRECLINICAL STUDIES; 9. RESEARCH OVERSIGHT; 10. THE INVESTIGATIONS BEGIN; 11. SCIENTIFIC MISCONDUCT; 12. THE FDA; 13. THE NATIONAL INSTITUTES OF HEALTH; 14. THE INSTITUTE OF MEDICINE; 15. THE MEDIA; 16. THE CONGRESS; 17. THE LAW; 18. EPILOGUE Acknowledgments |
| Record Nr. | UNINA-9910784640603321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene
| Principles and practice of clinical research [[electronic resource] /] / [edited by] John I. Gallin, Frederick P. Ognibene |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 |
| Descrizione fisica | 1 online resource (447 p.) |
| Disciplina | 616.0072 |
| Altri autori (Persone) |
GallinJohn I
OgnibeneFrederick P |
| Soggetto topico | Clinical medicine - Research |
| ISBN |
1-281-05227-2
9786611052270 0-08-048956-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front cover; Principles and Practice of Clinical Research; Copyright page; Table of contents; Preface; Acknowledgements; Contributors; Chapter 1: A Historical Perspective on Clinical Research; 1. THE EARLIEST CLINICAL RESEARCH; 2. THE GREEK AND ROMAN INFLUENCE; 3. MIDDLE AGES AND RENAISSANCE; 4. SEVENTEENTH CENTURY; 5. EIGHTEENTH CENTURY; 6. NINETEENTH CENTURY; 7. TWENTIETH CENTURY AND BEYOND; Acknowledgment; References and Notes; PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES; Chapter 2: Ethical Principles in Clinical Research; 1. DISTINGUISHING CLINICAL RESEARCHFROM CLINICAL PRACTICE
2. WHAT DOES ETHICS HAVE TO DOWITH CLINICAL RESEARCH?3. HISTORY OF ETHICAL ATTENTION TOCLINICAL RESEARCH; 4. CODES OF RESEARCH ETHICSAND REGULATIONS; 5. ETHICAL FRAMEWORK FORCLINICAL RESEARCH; 6. ETHICAL CONSIDERATIONS IN RANDOMIZED CLINICAL TRIALS; 7. CONCLUSION; References; Chapter 3: Researching a Bioethical Question; 1. TYPES OF BIOETHICAL ISSUES; 2. TYPES OF BIOETHICAL RESEARCH METHODOLOGIES; 3. EXAMPLES OF IMPORTANT BIOETHICAL RESEARCH; 4. SPECIAL CONSIDERATIONS INBIOETHICAL RESEARCH; References and Notes; Chapter 4: Integrity in Research: Individual and Institutional Responsibility 1. GUIDELINES FOR THE CONDUCTOF RESEARCH2. SCIENTIFIC INTEGRITY AND MISCONDUCT; 3. MENTOR-TRAINEE RELATIONSHIPS; 4. DATA ACQUISITION, MANAGEMENT, SHARING, AND OWNERSHIP; 5. RESEARCH INVOLVING HUMAN AND ANIMAL SUBJECTS; 6. COLLABORATIVE SCIENCE; 7. CONFLICT OF INTEREST AND COMMITMENT; 8. PEER REVIEW; 9. PUBLICATION PRACTICES AND RESPONSIBLE AUTHORSHIP; Acknowledgment; References; Chapter 5: Institutional Review Boards; 1. HISTORICAL, ETHICAL, ANDREGULATORY FOUNDATIONSOF CURRENT REQUIREMENTSFOR RESEARCH INVOLVINGHUMAN SUBJECTS; 2. INSTITUTIONAL REVIEW BOARDS; 3. CLINICAL RESEARCHERSAND IRBs 4. THE CURRENT IRB SYSTEM UNDER EVALUATION5. CONCLUSION; References and Notes; Chapter 6: Data and Safety Monitoring Boards; 1. DESCRIPTION OF THE DATA ANDSAFETY MONITORING BOARD; 2. DATA AND SAFETY MONITORINGBOARD FUNCTIONS; 3. DATA AND SAFETY MONITORINGBOARD DECISION MAKING; 4. EXAMPLES; 5. CONCLUSIONS; References; Chapter 7: Data Management in Clinical Trials; 1. THE RESEARCH TEAM; 2. PLANNING THE TRIAL; 3. WHERE ARE DATA?; 4. WHO CAN COLLECT DATA?; 5. SITE INITIATION VISIT; 6. INFORMED CONSENT; 7. ELIGIBILITY; 8. REGISTRATION; 9. WHAT DATA DO YOU COLLECT?; 10. TREATMENT PLAN 11. CONCURRENT THERAPY12. ADVERSE EVENT MONITORING; 13. ROUTINE MONITORING VISITS; 14. AUDIT TRAIL; 15. ELECTRONIC DATABASE; 16. SUMMARY; References; Chapter 8: Unanticipated Risk in Clinical Research; 1. THE REASONS; 2. THE DRUG; 3. THE TARGET; 4. THE TRIALS; 5. CASSANDRA REVEALED; 6. EXTENDED STUDIES; 7. FIAU TOXICITY; 8. REASSESSING THEPRECLINICAL STUDIES; 9. RESEARCH OVERSIGHT; 10. THE INVESTIGATIONS BEGIN; 11. SCIENTIFIC MISCONDUCT; 12. THE FDA; 13. THE NATIONAL INSTITUTES OF HEALTH; 14. THE INSTITUTE OF MEDICINE; 15. THE MEDIA; 16. THE CONGRESS; 17. THE LAW; 18. EPILOGUE Acknowledgments |
| Record Nr. | UNINA-9910822795903321 |
| Amsterdam ; ; Boston, : Elsevier/Academic Press, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||