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A Step by Step Guide to Clinical Trials : Cancer Nursing Ser. - Marilyn Mulay

A Step by Step Guide to Clinical Trials

Cancer Nursing Ser.

Hardcover Published: 4th October 2000
ISBN: 9780763715694
Number Of Pages: 143

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Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well-organized study. 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.

Prefacep. xi
Acknowledgmentsp. xv
The Business of Research
The Cancer Problemp. 3
Treatmentp. 4
Clinical Trialsp. 5
Phase I Studyp. 6
Phase II Studyp. 8
Phase III Studyp. 9
Phase IV Studyp. 9
Data Collectionp. 10
The Protocol Processp. 11
Understanding the Protocolp. 11
The Title Pagep. 12
Getting the Basicsp. 15
Background and Objectivesp. 16
Inclusion and Exclusion Criteriap. 16
Study Proceduresp. 17
Adverse Eventsp. 17
Statisticsp. 19
Appendicesp. 19
Really Understanding the Protocolp. 19
Regulatory Issuesp. 21
Institutional Review Boardsp. 21
The Need for the IRBp. 21
Ethics and the IRBp. 22
Informed Consentp. 23
Clarity of Languagep. 24
Level of Detailp. 24
Need for Translationp. 24
Late Details and Revisionsp. 24
Preparing a Consent Formp. 25
Consent Approvalp. 27
Form 1572p. 28
Statement of Economic Interestp. 28
Lay Language Summaryp. 28
Regulatory Binderp. 28
Protocolp. 28
Informed Consentp. 29
IRB Documentsp. 29
Study Correspondencep. 29
Tracking Logsp. 30
Signature Logp. 30
Delegation of Authority Formp. 30
The Budgetp. 35
Understanding the Basic Expensesp. 35
Determining Your Costsp. 37
Fixed Costsp. 37
Cycle 1 Costsp. 37
Sponsor Inputp. 39
Investigator Inputp. 40
Unreimbursed Expensesp. 40
Overheadp. 41
Award Synposisp. 41
Budget Adjustmentsp. 41
Payment Schedulep. 41
Billing Issuesp. 43
The Contractp. 45
Contract Negotiationp. 45
Signing the Contractp. 46
Protocol Amendmentsp. 46
Setting the Foundation
Initiating the Protocolp. 49
Investigators' Meetingp. 49
Site Visitp. 50
Site Initiation Visitp. 50
Case Report Formsp. 50
Preparing for Treatmentp. 53
Preparing the Ordersp. 53
Laboratory Requisitionsp. 55
Study Packetsp. 58
Appointment Schedulingp. 58
Inservicing the Treatment Staffp. 58
The Clinical Side
The Enrollment Processp. 63
Enrolling Patientsp. 63
Screening by Telephonep. 64
Preparing a Research Chartp. 66
The Screening Visitp. 67
The Waiting Roomp. 67
Medical Recordsp. 67
Vital Signs and Other Essentialsp. 68
Medications, Allergies, and Pregnancyp. 68
Other Options and Informed Consentp. 68
Signing and Distributing the Consentp. 69
The Investigator's Responsibilitiesp. 70
Confirming Contactsp. 70
Completing the Processp. 71
Treating the Patientp. 73
The Ordersp. 73
Recording the Patient's Visitsp. 74
Cycle Assessmentsp. 76
Restagingp. 76
Complete Responsep. 77
Partial Responsep. 77
Stable Diseasep. 77
Progressive Diseasep. 78
Study Coordinator's Rolep. 79
End of Treatmentp. 79
Follow-upp. 79
Pharmacokinetic Samplingp. 81
Understanding Pharmacokineticsp. 81
Preparing for PK Samplingp. 81
Shipping PK Samplesp. 82
The Data Side
Data Collectionp. 87
Understanding the Processp. 87
Screening Datap. 88
Past Medical Historyp. 88
Past Treatment Historyp. 89
Baseline Lesion Assessmentp. 91
Baseline Laboratory Testsp. 93
Baseline Signs and Symptomsp. 95
Treatment Datap. 96
Adverse Eventsp. 96
Serious Adverse Eventsp. 97
End of Studyp. 99
Follow-upp. 102
Commentsp. 103
Missing or Unknown Datap. 103
Tracking Datap. 103
The Monitoring Processp. 105
The Monitorp. 105
Visit Frequency and Overviewp. 105
Letter of Intentp. 106
Letter of Follow-upp. 106
The Common Goalp. 106
Preparing for the Visitp. 106
Data Correctionsp. 107
Pulling the Datap. 107
Queriesp. 108
Auditsp. 109
Preparing for an Auditp. 110
Protocol Violationsp. 110
Closing the Studyp. 113
Drug Disposalp. 113
Document Storagep. 113
Organizational Issues
Organizing a Research Programp. 117
Small Program--Heavy Workloadp. 117
Larger Program--More Balanced Workloadp. 118
Hiring Personnelp. 118
Decentralizing Responsibilitiesp. 118
Standard Operating Proceduresp. 121
Mission Statementp. 121
Site Administrationp. 121
Other Documentationp. 122
Appendixes
Understanding Physical Exam Findingsp. 127
Electronic Resourcesp. 131
Glossaryp. 133
Indexp. 139
Table of Contents provided by Syndetics. All Rights Reserved.

ISBN: 9780763715694
ISBN-10: 0763715697
Series: Cancer Nursing Ser.
Audience: Tertiary; University or College
Format: Hardcover
Language: English
Number Of Pages: 143
Published: 4th October 2000
Publisher: Jones and Bartlett Publishers, Inc
Country of Publication: US
Dimensions (cm): 22.23 x 15.88  x 1.91
Weight (kg): 0.22

Earn 293 Qantas Points
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