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A Step-by-Step Guide provides a practical approach to understanding the components of a clinical research trial, as well as the tools to conduct a well-organized study. This text is designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data.

Tabla de contenidos provista por Syndetics

• Preface(p. xi)
• Acknowledgments(p. xv)
• Part I The Business of Research
• Chapter 1 The Cancer Problem(p. 3)
• Treatment(p. 4)
• Clinical Trials(p. 5)
• Phase I Study(p. 6)
• Phase II Study(p. 8)
• Phase III Study(p. 9)
• Phase IV Study(p. 9)
• Data Collection(p. 10)
• Chapter 2 The Protocol Process(p. 11)
• Understanding the Protocol(p. 11)
• The Title Page(p. 12)
• Getting the Basics(p. 15)
• Background and Objectives(p. 16)
• Inclusion and Exclusion Criteria(p. 16)
• Study Procedures(p. 17)
• Adverse Events(p. 17)
• Statistics(p. 19)
• Appendices(p. 19)
• Really Understanding the Protocol(p. 19)
• Chapter 3 Regulatory Issues(p. 21)
• Institutional Review Boards(p. 21)
• The Need for the IRB(p. 21)
• Ethics and the IRB(p. 22)
• Informed Consent(p. 23)
• Clarity of Language(p. 24)
• Level of Detail(p. 24)
• Need for Translation(p. 24)
• Late Details and Revisions(p. 24)
• Preparing a Consent Form(p. 25)
• Consent Approval(p. 27)
• Form 1572(p. 28)
• Statement of Economic Interest(p. 28)
• Lay Language Summary(p. 28)
• Regulatory Binder(p. 28)
• Protocol(p. 28)
• Informed Consent(p. 29)
• IRB Documents(p. 29)
• Study Correspondence(p. 29)
• Tracking Logs(p. 30)
• Signature Log(p. 30)
• Delegation of Authority Form(p. 30)
• Chapter 4 The Budget(p. 35)
• Understanding the Basic Expenses(p. 35)
• Determining Your Costs(p. 37)
• Fixed Costs(p. 37)
• Cycle 1 Costs(p. 37)
• Sponsor Input(p. 39)
• Investigator Input(p. 40)
• Unreimbursed Expenses(p. 40)
• Overhead(p. 41)
• Award Synposis(p. 41)
• Budget Adjustments(p. 41)
• Payment Schedule(p. 41)
• Billing Issues(p. 43)
• Chapter 5 The Contract(p. 45)
• Contract Negotiation(p. 45)
• Signing the Contract(p. 46)
• Protocol Amendments(p. 46)
• Part II Setting the Foundation
• Chapter 6 Initiating the Protocol(p. 49)
• Investigators' Meeting(p. 49)
• Site Visit(p. 50)
• Site Initiation Visit(p. 50)
• Case Report Forms(p. 50)
• Chapter 7 Preparing for Treatment(p. 53)
• Preparing the Orders(p. 53)
• Laboratory Requisitions(p. 55)
• Study Packets(p. 58)
• Appointment Scheduling(p. 58)
• Inservicing the Treatment Staff(p. 58)
• Part III The Clinical Side
• Chapter 8 The Enrollment Process(p. 63)
• Enrolling Patients(p. 63)
• Screening by Telephone(p. 64)
• Preparing a Research Chart(p. 66)
• The Screening Visit(p. 67)
• The Waiting Room(p. 67)
• Medical Records(p. 67)
• Vital Signs and Other Essentials(p. 68)
• Medications, Allergies, and Pregnancy(p. 68)
• Other Options and Informed Consent(p. 68)
• Signing and Distributing the Consent(p. 69)
• The Investigator's Responsibilities(p. 70)
• Confirming Contacts(p. 70)
• Completing the Process(p. 71)
• Chapter 9 Treating the Patient(p. 73)
• The Orders(p. 73)
• Recording the Patient's Visits(p. 74)
• Cycle Assessments(p. 76)
• Restaging(p. 76)
• Complete Response(p. 77)
• Partial Response(p. 77)
• Stable Disease(p. 77)
• Progressive Disease(p. 78)
• Study Coordinator's Role(p. 79)
• End of Treatment(p. 79)
• Follow-up(p. 79)
• Chapter 10 Pharmacokinetic Sampling(p. 81)
• Understanding Pharmacokinetics(p. 81)
• Preparing for PK Sampling(p. 81)
• Shipping PK Samples(p. 82)
• Part IV The Data Side
• Chapter 11 Data Collection(p. 87)
• Understanding the Process(p. 87)
• Screening Data(p. 88)
• Past Medical History(p. 88)
• Past Treatment History(p. 89)
• Baseline Lesion Assessment(p. 91)
• Baseline Laboratory Tests(p. 93)
• Baseline Signs and Symptoms(p. 95)
• Treatment Data(p. 96)
• Adverse Events(p. 96)
• Serious Adverse Events(p. 97)
• End of Study(p. 99)
• Follow-up(p. 102)
• Comments(p. 103)
• Missing or Unknown Data(p. 103)
• Tracking Data(p. 103)
• Chapter 12 The Monitoring Process(p. 105)
• The Monitor(p. 105)
• Visit Frequency and Overview(p. 105)
• Letter of Intent(p. 106)
• Letter of Follow-up(p. 106)
• The Common Goal(p. 106)
• Preparing for the Visit(p. 106)
• Data Corrections(p. 107)
• Pulling the Data(p. 107)
• Queries(p. 108)
• Audits(p. 109)
• Preparing for an Audit(p. 110)
• Protocol Violations(p. 110)
• Chapter 13 Closing the Study(p. 113)
• Drug Disposal(p. 113)
• Document Storage(p. 113)
• Part V Organizational Issues
• Chapter 14 Organizing a Research Program(p. 117)
• Small Program--Heavy Workload(p. 117)
• Larger Program--More Balanced Workload(p. 118)
• Hiring Personnel(p. 118)
• Decentralizing Responsibilities(p. 118)
• Chapter 15 Standard Operating Procedures(p. 121)
• Mission Statement(p. 121)
• Site Administration(p. 121)
• Other Documentation(p. 122)
• Appendixes
• A. Understanding Physical Exam Findings(p. 127)
• B. Electronic Resources(p. 131)
• Glossary(p. 133)
• Index(p. 139)