LEADER 05418nam 22006494a 450 001 9910822795903321 005 20230120004637.0 010 $a1-281-05227-2 010 $a9786611052270 010 $a0-08-048956-7 035 $a(CKB)1000000000364157 035 $a(EBL)294318 035 $a(OCoLC)476057912 035 $a(SSID)ssj0000227224 035 $a(PQKBManifestationID)11188109 035 $a(PQKBTitleCode)TC0000227224 035 $a(PQKBWorkID)10264587 035 $a(PQKB)10557584 035 $a(MiAaPQ)EBC294318 035 $a(Au-PeEL)EBL294318 035 $a(CaPaEBR)ebr10186089 035 $a(CaONFJC)MIL105227 035 $a(EXLCZ)991000000000364157 100 $a20070201d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aPrinciples and practice of clinical research /$f[edited by] John I. Gallin, Frederick P. Ognibene 205 $a2nd ed. 210 $aAmsterdam ;$aBoston $cElsevier/Academic Press$dc2007 215 $a1 online resource (447 p.) 300 $aPrev. ed. cataloged as: Principles and practice of clinical research / John I. Gallin. 311 $a0-12-369440-X 320 $aIncludes bibliographical references and index. 327 $aFront 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 327 $a2. 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 327 $a1. 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 327 $a4. 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 327 $a11. 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 327 $aAcknowledgments 330 $aThe second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to 606 $aClinical medicine$xResearch 615 0$aClinical medicine$xResearch. 676 $a616.0072 676 $a616.0072 701 $aGallin$b John I$01700746 701 $aOgnibene$b Frederick P$01700747 701 $aGallin$b John I$01700746 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910822795903321 996 $aPrinciples and practice of clinical research$94083977 997 $aUNINA