{"product_id":"a-clinical-trials-manual-from-the-duke-clinical-research-institute-isbn-9781405195157","title":"A Clinical Trials Manual From The Duke Clinical Research Institute","description":"\"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity.\"\u003cbr\u003e —\u003cb\u003eRobert Harrington\u003c\/b\u003e, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA  \u003cp\u003eThe Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical \"nuts and bolts\" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.\u003c\/p\u003e \u003cp\u003eDesigned for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.\u003c\/p\u003e \u003cp\u003eUpdated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eIn-depth information on conducting clinical trials of medical devices and biologics\u003c\/li\u003e \u003cli\u003eThe role and responsibilities of Institutional Review Boards, and\u003c\/li\u003e \u003cli\u003eRecent developments regarding subject privacy concerns and regulations.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEthical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.\u003c\/p\u003e \u003cp\u003eForeword by Robert A. Harrington xiii\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eList of Abbreviations xviii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 The Process: Developing New Drugs, Biologics, and Devices 13\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Drug Development Process 14\u003c\/p\u003e \u003cp\u003eBackground Information 14\u003c\/p\u003e \u003cp\u003ePre-Clinical Studies 15\u003c\/p\u003e \u003cp\u003eThe Investigational New Drug Application 16\u003c\/p\u003e \u003cp\u003eClinical Trial Phases 17\u003c\/p\u003e \u003cp\u003eApplication to Market New Drugs and Biologics 20\u003c\/p\u003e \u003cp\u003eFDA Review Groups 21\u003c\/p\u003e \u003cp\u003eEarly or Expanded Access to Unapproved Drugs and Biologics 24\u003c\/p\u003e \u003cp\u003eOrphan Drugs 25\u003c\/p\u003e \u003cp\u003eDeveloping New Devices 26\u003c\/p\u003e \u003cp\u003eBackground Information 27\u003c\/p\u003e \u003cp\u003eWhat is a Medical Device? 28\u003c\/p\u003e \u003cp\u003eMedical Device Classification 29\u003c\/p\u003e \u003cp\u003eRequirements for Marketing New Devices 33\u003c\/p\u003e \u003cp\u003eHumanitarian Use Devices 36\u003c\/p\u003e \u003cp\u003eEarly or Expanded Access to Unapproved Medical Devices 36\u003c\/p\u003e \u003cp\u003eFDA Device Review 38\u003c\/p\u003e \u003cp\u003eCombination Products 38\u003c\/p\u003e \u003cp\u003ePostmarketing Surveillance of Drugs, Biologics, and Devices 39\u003c\/p\u003e \u003cp\u003ePhase 4 Postmarketing Drug and Biologics Studies 40\u003c\/p\u003e \u003cp\u003ePhase 4 Postmarketing Device Studies 40\u003c\/p\u003e \u003cp\u003eDirect Reporting Based on Observations 41\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Good Clinical Practice and the Regulations 49\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGood Clinical Practice 50\u003c\/p\u003e \u003cp\u003eRegulations 50\u003c\/p\u003e \u003cp\u003eGuidelines 59\u003c\/p\u003e \u003cp\u003eLocal Laws 60\u003c\/p\u003e \u003cp\u003eResponsibilities in the Code of Federal Regulations 62\u003c\/p\u003e \u003cp\u003ePrincipal Investigator Responsibilities 62\u003c\/p\u003e \u003cp\u003eInstitutional Review Board Responsibilities 67\u003c\/p\u003e \u003cp\u003eSponsor Responsibilities 68\u003c\/p\u003e \u003cp\u003eSponsor-Investigators 70\u003c\/p\u003e \u003cp\u003eWhere to Obtain Information and Guidance for the Regulations and GCP 70\u003c\/p\u003e \u003cp\u003eThe Federal Register 70\u003c\/p\u003e \u003cp\u003eFDA Guidance Documents 71\u003c\/p\u003e \u003cp\u003eOnline Resources 71\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Informed Consent and the Regulations 73\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat Is Informed Consent? 74\u003c\/p\u003e \u003cp\u003eEthical Codes Regarding Informed Consent 75\u003c\/p\u003e \u003cp\u003eThe Belmont Report: Application of Respect for Persons 75\u003c\/p\u003e \u003cp\u003eThe Declaration of Helsinki 76\u003c\/p\u003e \u003cp\u003eThe Nuremberg Code 77\u003c\/p\u003e \u003cp\u003eRegulatory Requirements for Informed Consent 77\u003c\/p\u003e \u003cp\u003eGeneral Requirements for Informed Consent (21 CFR 50.20) 78\u003c\/p\u003e \u003cp\u003eExceptions from the General Requirements (21 CFR 50.23) 79\u003c\/p\u003e \u003cp\u003eExceptions from Informed Consent Requirements for Emergency Research (21 CFR 50.24) 79\u003c\/p\u003e \u003cp\u003eElements of Informed Consent (21 CFR 50.25) 80\u003c\/p\u003e \u003cp\u003eDocumentation of Informed Consent (21 CFR 50.27) 82\u003c\/p\u003e \u003cp\u003eConsent from Vulnerable Subjects 85\u003c\/p\u003e \u003cp\u003eHIPAA\/Privacy Rule Requirements 90\u003c\/p\u003e \u003cp\u003eThe Informed Consent Process 92\u003c\/p\u003e \u003cp\u003eWriting the Consent Form 92\u003c\/p\u003e \u003cp\u003eObtaining Informed Consent 95\u003c\/p\u003e \u003cp\u003eDocumenting Informed Consent 96\u003c\/p\u003e \u003cp\u003eContinuing Informed Consent 97\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Institutional Review Boards 101\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat is an Institutional Review Board? 102\u003c\/p\u003e \u003cp\u003eTypes of IRBs 103\u003c\/p\u003e \u003cp\u003eIRB Membership 104\u003c\/p\u003e \u003cp\u003eIRB Activities 107\u003c\/p\u003e \u003cp\u003eReviewing Research 107\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Problems Involving Risks to Subjects or Others 109\u003cbr\u003e \u003cbr\u003e Establishing Written Procedures 110\u003c\/p\u003e \u003cp\u003eTypes of IRB Review 111\u003c\/p\u003e \u003cp\u003eFull Committee Review 111\u003c\/p\u003e \u003cp\u003eExpedited Review 112\u003c\/p\u003e \u003cp\u003eItems That Must be Submitted for IRB Review 113\u003c\/p\u003e \u003cp\u003eExemptions: When IRB Approval Is Not Required 113\u003c\/p\u003e \u003cp\u003eContinuing Review after Initial Study Approval 114\u003c\/p\u003e \u003cp\u003eReview of Adverse Events and Unanticipated Problems 115\u003c\/p\u003e \u003cp\u003eCommunication between IRBs and Investigators 116\u003c\/p\u003e \u003cp\u003eInvestigator Notification of the Outcome of IRB Review 116\u003c\/p\u003e \u003cp\u003eCommunication During Study 116\u003c\/p\u003e \u003cp\u003eIRB Notification at Study Completion 117\u003c\/p\u003e \u003cp\u003eCommunication between IRBs and Study Sponsors 117\u003c\/p\u003e \u003cp\u003eIRB Records and Reports 118\u003c\/p\u003e \u003cp\u003eAccreditation of IRBs 119\u003c\/p\u003e \u003cp\u003eRegistration 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhy Collect Adverse Event Data? 124\u003c\/p\u003e \u003cp\u003eSafety Profile 125\u003c\/p\u003e \u003cp\u003eBenefits and Risks Evaluation 125\u003c\/p\u003e \u003cp\u003ePackage Insert 125\u003c\/p\u003e \u003cp\u003eAdverse Events 125\u003c\/p\u003e \u003cp\u003eInternal and External Adverse Events 126\u003c\/p\u003e \u003cp\u003eSerious Adverse Events 126\u003c\/p\u003e \u003cp\u003eUnanticipated Problems Involving Risks to Subjects or Others 127\u003c\/p\u003e \u003cp\u003eInvestigator Responsibilities 129\u003c\/p\u003e \u003cp\u003eCollecting Adverse Event Data 129\u003c\/p\u003e \u003cp\u003eReporting Adverse Event Data 130\u003c\/p\u003e \u003cp\u003eExpedited Reporting of Adverse Events 131\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Problems Involving Risks to Subjects or Others 133\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Adverse Device Effects 135\u003c\/p\u003e \u003cp\u003eIRB Responsibilities 135\u003c\/p\u003e \u003cp\u003eReview and Reporting of Serious Adverse Events 135\u003c\/p\u003e \u003cp\u003eReview and Reporting of Unanticipated Problems 136\u003c\/p\u003e \u003cp\u003eSponsor Responsibilities 136\u003c\/p\u003e \u003cp\u003eExpedited Reporting in Drug Trials 137\u003c\/p\u003e \u003cp\u003eExpedited Reporting in Device Trials 138\u003c\/p\u003e \u003cp\u003eRoutine Reporting by Sponsors 139\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Monitoring, Audits, and Inspections 141\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eMonitoring Plan 143\u003c\/p\u003e \u003cp\u003eOn-Site Monitoring 144\u003c\/p\u003e \u003cp\u003eTypes of On-Site Monitoring Visits 145\u003c\/p\u003e \u003cp\u003eDocumenting Monitoring Visits 151\u003c\/p\u003e \u003cp\u003eIn-House Monitoring 152\u003c\/p\u003e \u003cp\u003eComputerized Checks 153\u003c\/p\u003e \u003cp\u003eSource Document Verification Done at the Sponsor or Data Center 153\u003c\/p\u003e \u003cp\u003eProtected Health Information 154\u003c\/p\u003e \u003cp\u003eAudits and Inspections 154\u003c\/p\u003e \u003cp\u003eAudits and Inspections in the Regulations and Guidelines 155\u003c\/p\u003e \u003cp\u003eSponsor Quality Assurance Audits 156\u003c\/p\u003e \u003cp\u003eFDA Inspections 157\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 The Principal Investigator, the Clinical Research Coordinator, and the Study Site 163\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Principal Investigator 164\u003c\/p\u003e \u003cp\u003eCharacteristics of an Effective Principal Investigator 165\u003c\/p\u003e \u003cp\u003eConflict of Interest 167\u003c\/p\u003e \u003cp\u003eInvestigator Delegation of Study Activities 169\u003c\/p\u003e \u003cp\u003eStaffing to Support Clinical Trials 169\u003c\/p\u003e \u003cp\u003eClinical Research Coordinator 169\u003c\/p\u003e \u003cp\u003eSubinvestigators 172\u003c\/p\u003e \u003cp\u003eSupport Personnel 173\u003c\/p\u003e \u003cp\u003eSpace and Resource Needs 173\u003c\/p\u003e \u003cp\u003eWorkspace for the Clinical Research Coordinator 173\u003c\/p\u003e \u003cp\u003eEquipment 174\u003c\/p\u003e \u003cp\u003eStorage Space 174\u003c\/p\u003e \u003cp\u003eAdditional Space 175\u003c\/p\u003e \u003cp\u003eThe Local Institutional Review Board 175\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 The Protocol 177\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eCommon Components of a Protocol 180\u003c\/p\u003e \u003cp\u003eBackground and Rationale 180\u003c\/p\u003e \u003cp\u003eStudy Organization 180\u003c\/p\u003e \u003cp\u003eObjectives\/Endpoints 181\u003c\/p\u003e \u003cp\u003eQuality of Life Parameters 181\u003c\/p\u003e \u003cp\u003eEconomic Factors 182\u003c\/p\u003e \u003cp\u003eSurrogate Endpoints 182\u003c\/p\u003e \u003cp\u003eStudy Design 183\u003c\/p\u003e \u003cp\u003eUse of Control Groups 184\u003c\/p\u003e \u003cp\u003eRandomization 185\u003c\/p\u003e \u003cp\u003eBlinding 187\u003c\/p\u003e \u003cp\u003eObservational Studies 188\u003c\/p\u003e \u003cp\u003eStudy Population 190\u003c\/p\u003e \u003cp\u003eStudy Treatment Plan 191\u003c\/p\u003e \u003cp\u003eSafety Assessment, Management, and Reporting 192\u003c\/p\u003e \u003cp\u003eReplacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects 193\u003c\/p\u003e \u003cp\u003eStatistical Aspects 193\u003c\/p\u003e \u003cp\u003ePower 193\u003c\/p\u003e \u003cp\u003eSample Size 193\u003c\/p\u003e \u003cp\u003eIntention-to-treat Principle 194\u003c\/p\u003e \u003cp\u003eInterim Analysis 195\u003c\/p\u003e \u003cp\u003eData and Safety Monitoring Board 196\u003c\/p\u003e \u003cp\u003eSubject Data and Record Retention 197\u003c\/p\u003e \u003cp\u003eMonitoring 197\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Study Feasibility: Reviewing a Specific Protocol 199\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReviewing a Specific Protocol 200\u003c\/p\u003e \u003cp\u003eStudy Design 200\u003c\/p\u003e \u003cp\u003eResearch Subject Population 201\u003c\/p\u003e \u003cp\u003eInvestigator Time Requirements 202\u003c\/p\u003e \u003cp\u003eClinical Research Coordinator and Other Study Personnel 202\u003c\/p\u003e \u003cp\u003eLaboratory Tests and Procedures 204\u003c\/p\u003e \u003cp\u003eAdditional Space and Equipment 205\u003c\/p\u003e \u003cp\u003eBudget Considerations 206\u003c\/p\u003e \u003cp\u003ePreparing a Budget 207\u003c\/p\u003e \u003cp\u003eBudget Planning 209\u003c\/p\u003e \u003cp\u003eNegotiating a Budget 211\u003c\/p\u003e \u003cp\u003eShould We Do this Study at Our Site? 211\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Study Activities 213\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStudy Start-up Phase 215\u003c\/p\u003e \u003cp\u003eReview the Protocol, Develop a Budget, Prepare Documents for IRB Submission 215\u003c\/p\u003e \u003cp\u003eEstablish the Site Study Team 216\u003c\/p\u003e \u003cp\u003eParticipate in Investigator Meetings 219\u003c\/p\u003e \u003cp\u003eDevelop a Recruitment and Enrollment Plan 219\u003c\/p\u003e \u003cp\u003eConduct Education and Training Sessions for Site Personnel 228\u003c\/p\u003e \u003cp\u003eBegin Randomization and Enrollment of Subjects 230\u003c\/p\u003e \u003cp\u003eStudy Maintenance Phase 230\u003c\/p\u003e \u003cp\u003eComplete Data Forms 231\u003c\/p\u003e \u003cp\u003eReport Serious Adverse Events (SAE) and Unanticipated Problems 231\u003c\/p\u003e \u003cp\u003eConduct Subject Follow-up Visits 231\u003c\/p\u003e \u003cp\u003eEnsure Subject Retention and Compliance 233\u003c\/p\u003e \u003cp\u003eUnblind Study Treatment Only When Required 238\u003c\/p\u003e \u003cp\u003eMaintain Study Drug\/Device Accountability 239\u003c\/p\u003e \u003cp\u003eManage Specimens, Samples, and Other Study-related Materials 239\u003c\/p\u003e \u003cp\u003eObtain Answers to Urgent Clinical Questions 239\u003c\/p\u003e \u003cp\u003eContinue Communication 239\u003c\/p\u003e \u003cp\u003eMaintain Study File 240\u003c\/p\u003e \u003cp\u003eStudy Completion and Close-Out Phase 240\u003c\/p\u003e \u003cp\u003eCompletion of All Subject Data Forms and Resolution of Data Queries 241\u003c\/p\u003e \u003cp\u003eDestruction or Return of Study Materials 241\u003c\/p\u003e \u003cp\u003eReview of Site Study File 241\u003c\/p\u003e \u003cp\u003eSubmission of the Final Report 241\u003c\/p\u003e \u003cp\u003eLong-term Storage of Study Records 242\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Study Documents\/Essential Documents 245\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDocuments at Study Start-Up 246\u003c\/p\u003e \u003cp\u003eConfidentiality Agreement 247\u003c\/p\u003e \u003cp\u003eSigned Protocol and Applicable Amendments 247\u003c\/p\u003e \u003cp\u003eLetter of Agreement 247\u003c\/p\u003e \u003cp\u003eInvestigator’s Brochure 248\u003c\/p\u003e \u003cp\u003eCurriculum Vitae (CV)\/Statement of Investigator Qualifications 248\u003c\/p\u003e \u003cp\u003eMedical Licensure Form 248\u003c\/p\u003e \u003cp\u003eForm FDA 1572 248\u003c\/p\u003e \u003cp\u003eFinancial Disclosure Information 250\u003c\/p\u003e \u003cp\u003eIRB Approval 250\u003c\/p\u003e \u003cp\u003eIRB-Approved Consent Form 252\u003c\/p\u003e \u003cp\u003eRB-Approved Advertisements and Subject Materials 253\u003c\/p\u003e \u003cp\u003eLaboratory Certification and Normal Ranges Form 253\u003c\/p\u003e \u003cp\u003eSite Demographics Form 255\u003c\/p\u003e \u003cp\u003eStudy Personnel CVs\/Résumés and Training Records 255\u003c\/p\u003e \u003cp\u003eContractual Agreement\/Financial Contract 255\u003c\/p\u003e \u003cp\u003eDocuments While the Study is in Progress 256\u003c\/p\u003e \u003cp\u003eProtocol Amendments and IRB Approval 256\u003c\/p\u003e \u003cp\u003eRevised Consent Forms and IRB Approval 257\u003c\/p\u003e \u003cp\u003eUpdated Form FDA 1572 257\u003c\/p\u003e \u003cp\u003eCVs for New PIs and Subinvestigators 257\u003cbr\u003e \u003cbr\u003e Updated Laboratory Certification and Normal Ranges Form 258\u003c\/p\u003e \u003cp\u003eIRB Correspondence 258\u003c\/p\u003e \u003cp\u003eSubject Recruitment Advertisements and Educational Materials 258\u003c\/p\u003e \u003cp\u003eScreening Log 258\u003c\/p\u003e \u003cp\u003eConfidential Master Subject Log 259\u003c\/p\u003e \u003cp\u003eSigned Consent Forms for All Enrolled Subjects 259\u003c\/p\u003e \u003cp\u003eTest Article Accountability Forms 259\u003c\/p\u003e \u003cp\u003eSerious and Reportable Adverse Event Forms 259\u003c\/p\u003e \u003cp\u003eSubject Data Forms and Query Forms 261\u003c\/p\u003e \u003cp\u003eSource Documents 261\u003c\/p\u003e \u003cp\u003eSignature and Delegation Log 263\u003c\/p\u003e \u003cp\u003eSite Visit Log 263\u003c\/p\u003e \u003cp\u003eWritten Communication and Correspondence 263\u003c\/p\u003e \u003cp\u003eDocuments at Study Close-out 263\u003c\/p\u003e \u003cp\u003eOutstanding Data Forms and Query Forms 264\u003c\/p\u003e \u003cp\u003eComplete Sets of All Subject Data Forms 264\u003c\/p\u003e \u003cp\u003eFinal Reports 264\u003c\/p\u003e \u003cp\u003eTest Article Accountability Records 264\u003c\/p\u003e \u003cp\u003eMaintaining Your Site Study File 266\u003c\/p\u003e \u003cp\u003eRecord Retention 266\u003c\/p\u003e \u003cp\u003ePrincipal Investigator Status Change 267\u003c\/p\u003e \u003cp\u003eFinal Financial Disclosure Report 267\u003c\/p\u003e \u003cp\u003eSample Study File Organization 267\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Management of Study Drugs, Biologics, and Devices 271\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStudy Drugs and Biologics 272\u003c\/p\u003e \u003cp\u003eStudy Drug Accountability 272\u003c\/p\u003e \u003cp\u003eStudy Drug Packaging 273\u003c\/p\u003e \u003cp\u003eStudy Drug Receipt 274\u003c\/p\u003e \u003cp\u003eStudy Drug Storage 274\u003c\/p\u003e \u003cp\u003eDispensing Study Drug 274\u003c\/p\u003e \u003cp\u003eStudy Drug Unblinding 277\u003c\/p\u003e \u003cp\u003eFinal Disposition of Study Drug 278\u003c\/p\u003e \u003cp\u003eStudy Devices 278\u003c\/p\u003e \u003cp\u003eDevice Labeling 278\u003c\/p\u003e \u003cp\u003eDevice Accountability 279\u003c\/p\u003e \u003cp\u003eDevice Tracking 279\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Managing Clinical Trial Data 281\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eHIPAA, the Privacy Rule, and Clinical Trial Data 282\u003c\/p\u003e \u003cp\u003eUse of Protected Health Information With Individual Authorization 283\u003c\/p\u003e \u003cp\u003eUse of Protected Health Information Without Individual Authorization 283\u003c\/p\u003e \u003cp\u003eSubject Identifiers 284\u003c\/p\u003e \u003cp\u003eGuidelines and Regulations Regarding Clinical Trial Data 284\u003c\/p\u003e \u003cp\u003eICH E6 Section 2: The Principles of ICH GCP 284\u003c\/p\u003e \u003cp\u003eICH E6 Section 4: Records and Reports 285\u003c\/p\u003e \u003cp\u003e21 CFR 312 and §812 285\u003c\/p\u003e \u003cp\u003eElectronic Data 285\u003c\/p\u003e \u003cp\u003eStudy Site Responsibilities Regarding Clinical Trial Data 287\u003c\/p\u003e \u003cp\u003eRecord the Data in Source Documents 287\u003c\/p\u003e \u003cp\u003eComplete Data Forms 290\u003c\/p\u003e \u003cp\u003eCorrect the Data 302\u003c\/p\u003e \u003cp\u003eSubmit the Data 307\u003c\/p\u003e \u003cp\u003eStore\/Archive the Data 308\u003c\/p\u003e \u003cp\u003eSource Document Verification of Clinical Trial Data 308\u003c\/p\u003e \u003cp\u003eRelease of Protected Medical Information 309\u003c\/p\u003e \u003cp\u003eConfidentiality of Clinical Trial Data 310\u003c\/p\u003e \u003cp\u003eEndpoint Adjudication 310\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Global Health and International Trials 313\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eInternational Clinical Trials 314\u003c\/p\u003e \u003cp\u003eEthnic and Racial Differences 315\u003c\/p\u003e \u003cp\u003eEthical Issues and Cultural Sensitivities 316\u003c\/p\u003e \u003cp\u003eWhy International Trials Are Important 317\u003c\/p\u003e \u003cp\u003eHIV\/AIDS 318\u003c\/p\u003e \u003cp\u003eMalaria 318\u003c\/p\u003e \u003cp\u003eTuberculosis 318\u003c\/p\u003e \u003cp\u003ePolio 319\u003c\/p\u003e \u003cp\u003eInternational Regulations 320\u003c\/p\u003e \u003cp\u003eConcerns 321\u003c\/p\u003e \u003cp\u003eFuture Efforts 322\u003c\/p\u003e \u003cp\u003eAppendices 325\u003c\/p\u003e \u003cp\u003eAppendix A 327\u003c\/p\u003e \u003cp\u003eAppendix B 342\u003c\/p\u003e \u003cp\u003eAppendix C 355\u003c\/p\u003e \u003cp\u003eAppendix D 362\u003c\/p\u003e \u003cp\u003eAppendix E 370\u003c\/p\u003e \u003cp\u003eEpilogue by Lisa G. Berdan 379\u003c\/p\u003e \u003cp\u003eGlossary 382\u003c\/p\u003e \u003cp\u003eIndex 395\u003c\/p\u003e  \"This is an excellent guide to how to conduct clinical trials of medical devices and biologics in the light of recent regulatory and clinical developments. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered. This manual also provides sample forms and worksheets for data management.\" (Doody's, 5 August 2011)  \u003cp\u003e\"A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition\" is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge.\" (Journal of Clinical Research Best Practices, 8 August 2011)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e  \u003cb\u003eMargaret Liu\u003c\/b\u003e is a clinical trials consultant based in Singapore and former manager of the Monitoring Group at the Duke Clinical Research Institute (DCRI).  \u003cp\u003e\u003cb\u003eKate Davis\u003c\/b\u003e is Business Development Specialist for DCRI Communications Group, Durham, NC, US.\u003c\/p\u003e  \"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity.\"\u003cbr\u003e —\u003cb\u003eRobert Harrington\u003c\/b\u003e, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA  \u003cp\u003eThe Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical \"nuts and bolts\" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.\u003c\/p\u003e \u003cp\u003eDesigned for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.\u003c\/p\u003e \u003cp\u003eUpdated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eIn-depth information on conducting clinical trials of medical devices and biologics\u003c\/li\u003e \u003cli\u003eThe role and responsibilities of Institutional Review Boards, and\u003c\/li\u003e \u003cli\u003eRecent developments regarding subject privacy concerns and regulations\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEthical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":47988599226597,"sku":"NP9781405195157","price":96.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781405195157.jpg?v=1761780915","url":"https:\/\/k12savings.com\/es\/products\/a-clinical-trials-manual-from-the-duke-clinical-research-institute-isbn-9781405195157","provider":"K12savings","version":"1.0","type":"link"}