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A Step-By-Step Guide to Clinical Trials

by: Mulay, Marilyn

A Step-By-Step Guide to Clinical Trials

by: Mulay, Marilyn

ISBN 13:
9780763715694
ISBN 10:
0763715697
Edition: 1st
Format: Paperback
Copyright: 10/01/2000
Publisher: Jones & Bartlett

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Summary

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.

Preface

Acknowledgments

PART I The Business of Research

The Cancer Problem

(8)

Treatment

(1)

Clinical Trials

(5)

Phase I Study

(2)

Phase II Study

(1)

Phase III Study

(1)

Phase IV Study

(1)

Data Collection

(1)

The Protocol Process

(10)

Understanding the Protocol

(8)

The Title Page

(3)

Getting the Basics

(1)

Background and Objectives

(1)

Inclusion and Exclusion Criteria

(1)

Study Procedures

(1)

Adverse Events

(2)

Statistics

(1)

Appendices

(1)

Really Understanding the Protocol

(2)

Regulatory Issues

(14)

Institutional Review Boards

(2)

The Need for the IRB

(1)

Ethics and the IRB

(1)

Informed Consent

(5)

Clarity of Language

(1)

Level of Detail

(1)

Need for Translation

(1)

Late Details and Revisions

(1)

Preparing a Consent Form

(2)

Consent Approval

(1)

Form 1572

(1)

Statement of Economic Interest

(1)

Lay Language Summary

(1)

Regulatory Binder

(7)

Protocol

(1)

Informed Consent

(1)

IRB Documents

(1)

Study Correspondence

(1)

Tracking Logs

(1)

Signature Log

(1)

Delegation of Authority Form

(5)

The Budget

(10)

Understanding the Basic Expenses

(2)

Determining Your Costs

(3)

Fixed Costs

(1)

Cycle 1 Costs

(2)

Sponsor Input

(1)

Investigator Input

(1)

Unreimbursed Expenses

(1)

Overhead

(1)

Award Synopsis

(1)

Budget Adjustments

(1)

Payment Schedule

(2)

Billing Issues

(2)

The Contract

(4)

Contract Negotiation

(1)

Signing the Contract

(1)

Protocol Amendments

(3)

PART II Setting the Foundation

Initiating the Protocol

(4)

Investigators' Meeting

(1)

Site Visit

(1)

Site Initiation Visit

(1)

Case Report Forms

(3)

Preparing for Treatment

(10)

Preparing the Orders

(2)

Laboratory Requisitions

(3)

Study Packets

(1)

Appointment Scheduling

(1)

Inservicing the Treatment Staff

(5)

PART III The Clinical Side

The Enrollment Process

(10)

Enrolling Patients

(1)

Screening by Telephone

(2)

Preparing a Research Chart

(1)

The Screening Visit

(3)

The Waiting Room

(1)

Medical Records

(1)

Vital Signs and Other Essentials

(1)

Medications, Allergies, and Pregnancy

(1)

Other Options and Informed Consent

(1)

Signing and Distributing the Consent

(1)

The Investigator's Responsibilities

(1)

Confirming Contacts

(1)

Completing the Process

(2)

Treating the Patient

(8)

The Orders

(1)

Recording the Patient's Visits

(2)

Cycle Assessments

(1)

Restaging

(3)

Complete Response

(1)

Partial Response

(1)

Stable Disease

(1)

Progressive Disease

(1)

Study Coordinator's Role

(1)

End of Treatment

(1)

Follow-up

(2)

Pharmacokinetic Sampling

(6)

Understanding Pharmacokinetics

(1)

Preparing for PK Sampling

(1)

Shipping PK Samples

(5)

PART IV The Data Side

Data Collection

(18)

Understanding the Process

(1)

Screening Data

(8)

Past Medical History

(1)

Past Treatment History

(2)

Baseline Lesion Assessment

(2)

Baseline Laboratory Tests

(2)

Baseline Signs and Symptoms

(1)

Treatment Data

(3)

Adverse Events

(1)

Serious Adverse Events

(2)

End of Study

(4)

Follow-up

102

(1)

Comments

103

(1)

Missing or Unknown Data

103

(1)

Tracking Data

103

(2)

The Monitoring Process

105

(8)

The Monitor

105

(1)

Visit Frequency and Overview

105

(1)

Letter of Intent

106

(1)

Letter of Follow-up

106

(1)

The Common Goal

106

(1)

Preparing for the Visit

106

(1)

Data Corrections

107

(1)

Pulling the Data

107

(1)

Queries

108

(1)

Audits

109

(4)

Preparing for an Audit

110

(1)

Protocol Violations

110

(3)

Closing the Study

113

(4)

Drug Disposal

113

(1)

Document Storage

113

(4)

PART V Organizational Issues

Organizing a Research Program

117

(4)

Small Program---Heavy Workload

117

(1)

Larger Program---More Balanced Workload

118

(1)

Hiring Personnel

118

(1)

Decentralizing Responsibilities

118

(3)

Standard Operating Procedures

121

(12)

Mission Statement

121

(1)

Site Administration

121

(1)

Amazon no longer offers textbook rentals. We do!

A Step-By-Step Guide to Clinical Trials

A Step-By-Step Guide to Clinical Trials

9780763715694

0763715697

Summary

Table of Contents

Supplemental Materials

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