The CRC's Guide To Coordinating Clinical Research,9781930624467

The CRC's Guide To Coordinating Clinical Research

by
Edition: 1st
ISBN13: 9781930624467
ISBN10: 1930624468
Format: Paperback
Pub. Date: 2004-09-01
Publisher(s): Centerwatch Inc
List Price: $85.35

Rent Textbook

Select for Price
Add to Cart
There was a problem. Please try again later.

New Textbook

We're Sorry
Sold Out

Used Textbook

We're Sorry
Sold Out

eTextbook

We're Sorry
Not Available

Buy from our Marketplace starting at $4.06

How Marketplace Works:

  • This item is offered by an independent seller and not shipped from our warehouse
  • Item details like edition and cover design may differ from our description; see seller's comments before ordering.
  • Sellers much confirm and ship within two business days; otherwise, the order will be cancelled and refunded.
  • Marketplace purchases cannot be returned to eCampus.com. Contact the seller directly for inquiries; if no response within two days, contact customer service.
  • Additional shipping costs apply to Marketplace purchases. Review shipping costs at checkout.

Summary

This comprehensive guide offers CRCs, and those who would like to become CRCs, the information they need to successfully coordinate a clinical trial from study startup to closeout and beyond. Book jacket.

Author Biography

Karen E. Woodin, Ph.D., is a consultant/trainer to the pharmaceutical industry in the areas of clinical operations, GCPs, SOPs, IRBs and site monitoring. She is actively involved in DIA, chairing workshops relevant to clinical trial management activities.

Table of Contents

Chapter 1: The Clinical Research Coordinator (CRC) 1(8)
Background and Training of the CRC
1(1)
Personality and Skills
2(1)
Where Do CRCs Work?
3(1)
CRC Responsibilities
4(3)
Problems and Opportunities
7(2)
Chapter 2: Institutional Review Boards (IRBs) 9(12)
Introduction
9(1)
Types of IRBs
10(1)
IRB Membership
10(1)
IRB Operations
11(1)
IRB Responsibilities
11(2)
Vulnerable Subjects
13(1)
State and Local Regulations
13(1)
IRB Review of Proposed Research
14(1)
Materials Submitted to the IRB by an Investigator
14(1)
IRB Deliberations
15(1)
Investigator Reporting Responsibilities
16(1)
Continuing Review of a Research Study
17(1)
Expedited Review
18(1)
Conflict of Interest
18(1)
CRC Duties and Responsibilities
19(1)
Key Things to Remember
19(2)
Chapter 3: Informed Consent 21(14)
Introduction
21(1)
Defining Informed Consent
21(1)
Preparing the Informed Consent Document
22(5)
Obtaining Informed Consent
27(2)
The Consent Process
29(2)
Exceptions from Consent
31(3)
Conclusion
34(1)
Key Things to Remember
34(1)
Chapter 4: Regulations and Good Clinical Practices (GCPs) 35(12)
Introduction
35(1)
FDA Regulations for Clinical Trials
36(1)
ICH Guidelines for Good Clinical Practice
36(1)
FDA Compliance Program Guidance Manuals
37(1)
NIH Regulated Research
38(1)
FDA Bioresearch Monitoring Program (BIMO)
38(1)
Good Clinical Practice (GCP)
38(1)
Contacting the FDA
39(1)
HIPAA
39(1)
HIPAA Authorization
39(1)
Protected Health Information (PHI)
40(1)
Recruitment of Study Subjects
41(2)
Obtaining Informed Consent under HIPAA
43(1)
The Declaration of Helsinki (1964)
44(1)
The Belmont Report (1979)
44(1)
Key Things to Remember
45(2)
Chapter 5: An Overview of Research 47(12)
Introduction
47(1)
Pre-Clinical Research
47(3)
Clinical Trials
50(4)
Notes on Studies in Women and Children
54(3)
Summary
57(1)
Key Things to Remember
58(1)
Chapter 6: Standard Operating Procedures (SOPs) 59(14)
Writing SOPs
60(6)
Approval, Training and Implementation
66(1)
SOPs for Investigative Sites
66(6)
Key Things to Remember:
72(1)
Chapter 7: Protocols and Case Report Forms (CRFs) 73(18)
Introduction
73(1)
Protocols
73(9)
Case Report Forms (CRFs)
82(4)
Electronic Data Capture (EDC)
86(1)
Good, High Quality Data
87(1)
Internal Quality Assurance
88(1)
Key Things to Remember
89(2)
Chapter 8: Preparing for a Study 91(22)
Introduction
91(1)
Site Assessments (Site Evaluations)
91(3)
Protocol Feasibility
94(1)
Grants, Budgeting and Contracts
95(3)
Investigative Site Study Files
98(4)
Storage of Study Materials
102(1)
Study Documents
103(1)
Financial Disclosure
104(2)
Investigator Meetings
106(1)
Study Initiation Meetings
107(2)
Working With CRAs
109(1)
Other Sponsor Interactions
109(1)
Shipping of Biological Samples
110(1)
Key Things to Remember
111(2)
Chapter 9: Working with Study Subjects 113(26)
Recruitment of Study Subjects
113(4)
Advertising for Study Subjects
117(3)
Other Recruitment Methods
120(2)
Information for Potential Study Subjects
122(1)
Compensation to Research Subjects
122(1)
Incentive Payments to Healthcare Professionals
123(1)
Summary: Recruitment
124(1)
Scheduling Subjects
125(2)
Retention of Study Subjects
127(4)
Summary: Retention
131(1)
Subject Compliance
131(5)
Key Things to Remember
136(3)
Chapter 10: Study Closure 139(8)
Introduction
139(1)
Reasons for Study Closure
139(1)
Closure Procedures
140(1)
Investigator's Final Report to the Sponsor and the IRB
141(1)
Administrative Issues
142(1)
Record Retention
142(1)
Post-Study Critique
143(4)
Chapter 11: Adverse Events and Safety Monitoring 147(14)
Regulations
147(2)
Definitions
149(1)
Adverse Events (AEs) on Marketed Products
150(1)
Adverse Events (AEs) in Clinical Trials
151(4)
Investigator Reporting Responsibilities
155(1)
Sponsor Responsibilities
155(1)
Differences Between Clinical Studies and Clinical Practice
156(1)
Assessing the Relationship of an AE to the Study Drug
157(1)
Common Reporting Problems
158(1)
Key Things to Remember
159(2)
Chapter 12: Audits 161(10)
Sponsor Audits of Investigative Sites
161(2)
IRB Audits of Investigative Sites
163(1)
FDA Audits of Investigative Sites
163(5)
Consequences
168(1)
Key Things to Remember
169(2)
Afterword 171(2)
Appendix A: Acronyms 173(2)
Appendix B: Glossary 175(6)
Appendix C: Resources 181(4)
Appendix D: Sample Forms, Logs and Checklists 185(38)
Appendix E: Code of Federal Regulations 223(118)
Appendix F: Harmonized Tripartite Guideline for Good Clinical Practice 341(54)
Appendix G: Examination 395(10)
About Thomson CenterWatch 405

An electronic version of this book is available through VitalSource.

This book is viewable on PC, Mac, iPhone, iPad, iPod Touch, and most smartphones.

By purchasing, you will be able to view this book online, as well as download it, for the chosen number of days.

Digital License

You are licensing a digital product for a set duration. Durations are set forth in the product description, with "Lifetime" typically meaning five (5) years of online access and permanent download to a supported device. All licenses are non-transferable.

More details can be found here.

A downloadable version of this book is available through the eCampus Reader or compatible Adobe readers.

Applications are available on iOS, Android, PC, Mac, and Windows Mobile platforms.

Please view the compatibility matrix prior to purchase.