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The CRC's guide to coordinating clinical research / Karen E. Woodin.
Holman Biotech Commons R853.C55 .W66 2004
Available
Levy Dental Medicine Library - Stacks R853.C55 W66 2004
Available
- Format:
- Book
- Author/Creator:
- Woodin, Karen E.
- Language:
- English
- Subjects (All):
- Clinical trials--Law and legislation--United States.
- Clinical trials.
- Drugs--Testing--Law and legislation--United States.
- Drugs.
- Clinical Trials as Topic--standards.
- Drugs--Testing--Law and legislation.
- Clinical trials--Law and legislation.
- United States.
- Clinical Trials as Topic--legislation & jurisprudence.
- Drug Approval--organization & administration.
- Ethics, Research.
- Guideline Adherence.
- Research Design.
- Medical Subjects:
- Clinical Trials as Topic--standards.
- United States.
- Clinical Trials as Topic--legislation & jurisprudence.
- Drug Approval--organization & administration.
- Ethics, Research.
- Guideline Adherence.
- Research Design.
- Physical Description:
- 411 pages : illustrations ; 23 cm
- Other Title:
- Coordinating clinical research
- Clinical research coordinator's guide to coordinating clinical research
- Place of Publication:
- Boston, MA : Thomson CenterWatch, [2004]
- Summary:
- This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.
- Contents:
- Chapter 1 The Clinical Research Coordinator (CRC) 1
- Background and Training of the CRC 1
- Personality and Skills 2
- Where Do CRCs Work? 3
- CRC Responsibilities 4
- Problems and Opportunities 7
- Chapter 2 Institutional Review Boards (IRBs) 9
- Types of IRBs 10
- IRB Membership 10
- IRB Operations 11
- IRB Responsibilities 11
- Vulnerable Subjects 13
- State and Local Regulations 13
- IRB Review of Proposed Research 14
- Materials Submitted to the IRB by an Investigator 14
- IRB Deliberations 15
- Investigator Reporting Responsibilities 16
- Continuing Review of a Research Study 17
- Expedited Review 18
- Conflict of Interest 18
- CRC Duties and Responsibilities 19
- Chapter 3 Informed Consent 21
- Preparing the Informed Consent Document 22
- Obtaining Informed Consent 27
- The Consent Process 29
- Exceptions from Consent 31
- Chapter 4 Regulations and Good Clinical Practices (GCPs) 35
- FDA Regulations for Clinical Trials 36
- ICH Guidelines for Good Clinical Practice 36
- FDA Compliance Program Guidance Manuals 37
- NIH Regulated Research 38
- FDA Bioresearch Monitoring Program (BIMO) 38
- Good Clinical Practice (GCP) 38
- Contacting the FDA 39
- HIPAA 39
- HIPAA Authorization 39
- Protected Health Information (PHI) 40
- Recruitment of Study Subjects 41
- Obtaining Informed Consent under HIPAA 43
- The Declaration of Helsinki (1964) 44
- The Belmont Report (1979) 44
- Chapter 5 An Overview of Research 47
- Pre-Clinical Research 47
- Clinical Trials 50
- Notes on Studies in Women and Children 54
- Chapter 6 Standard Operating Procedures (SOPs) 59
- Writing SOPs 60
- Approval, Training and Implementation 66
- SOPs for Investigative Sites 66
- Key Things to Remember 72
- Chapter 7 Protocols and Case Report Forms (CRFs) 73
- Electronic Data Capture (EDC) 86
- Good, High Quality Data 87
- Internal Quality Assurance 88
- Chapter 8 Preparing for a Study 91
- Site Assessments (Site Evaluations) 91
- Protocol Feasibility 94
- Grants, Budgeting and Contracts 95
- Investigative Site Study Files 98
- Storage of Study Materials 102
- Study Documents 103
- Financial Disclosure 104
- Investigator Meetings 106
- Study Initiation Meetings 107
- Working With CRAs 109
- Other Sponsor Interactions 109
- Shipping of Biological Samples 110
- Chapter 9 Working with Study Subjects 113
- Recruitment of Study Subjects 113
- Advertising for Study Subjects 117
- Other Recruitment Methods 120
- Information for Potential Study Subjects 122
- Compensation to Research Subjects 122
- Incentive Payments to Healthcare Professionals 123
- Scheduling Subjects 125
- Retention of Study Subjects 127
- Subject Compliance 131
- Chapter 10 Study Closure 139
- Reasons for Study Closure 139
- Closure Procedures 140
- Investigator's Final Report to the Sponsor and the IRB 141
- Administrative Issues 142
- Record Retention 142
- Post-Study Critique 143
- Chapter 11 Adverse Events and Safety Monitoring 147
- Regulations 147
- Adverse Events (AEs) on Marketed Products 150
- Adverse Events (AEs) in Clinical Trials 151
- Investigator Reporting Responsibilities 155
- Sponsor Responsibilities 155
- Differences Between Clinical Studies and Clinical Practice 156
- Assessing the Relationship of an AE to the Study Drug 157
- Common Reporting Problems 158
- Chapter 12 Audits 161
- Sponsor Audits of Investigative Sites 161
- IRB Audits of Investigative Sites 163
- FDA Audits of Investigative Sites 163
- Consequences 168
- Appendix E Code of Federal Regulations 223
- Appendix F Harmonized Tripartite Guideline for Good Clinical Practice 341
- Appendix G Examination 395.
- Notes:
- Includes bibliographical references.
- Readers of this guide can take an online exam to apply for approximately 10 nursing contact hours. Thomson CenterWatch and Thomson American Health Consultants, providers of this continuing education offering, are accredited by the American Nurses Credentialing Center's Commission on Accreditation.
- ISBN:
- 1930624468
- OCLC:
- 56968786
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