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The Sourcebook for Clinical Research - 1st Edition - ISBN: 9780128162422, 9780128162439

The Sourcebook for Clinical Research

1st Edition

A Practical Guide for Study Conduct

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Authors: Natasha Martien Jeff Nelligan
Paperback ISBN: 9780128162422
eBook ISBN: 9780128162439
Imprint: Academic Press
Published Date: 8th August 2018
Page Count: 274
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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics.

This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.

Key Features

  • Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP)
  • Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process
  • Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits
  • Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately.
  • Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly


Principal Investigators, Physicians, Research Nurses, Pharmacists, IRB members, Human Research Protections Office staff at all levels, Clinical Research Coordinators, CRO (Contract Research Organization) staff at all levels, hospital compliance office staff at all levels

Table of Contents

CHAPTER 1: Foundational Elements and Regulatory Requirements
1.1 What is the Purpose of Medical Research?
1.2 Defining the Types of Research Studies
1.3 Mandatory Regulations and ICH GCP (International Council for Harmonisation Good Clinical Practice) Ethical Guidelines
1.4 How to Secure a Clinical Trial and How to Market Your Medical Facility to Sponsors
1.5 Principal Investigator (PI) Responsibilities
1.6 Research Coordinator (RC) Responsibilities
1.7 Understanding the Role of HIPAA and PHI in Clinical Research Endnotes

CHAPTER 2: Preparation Before a Clinical Trial Begins
2.1 Clinical Trial Feasibility Analysis
2.2 Financial Conflict of Interest Regulations in a Clinical Trial
2.3 Confidentiality Disclosure Agreement (Also Known as a Non-Disclosure Agreement)
2.4 The Clinical Trial Contract (Also Known as a Clinical Services Agreement/CSA or a Clinical Trial Agreement/CTA)
2.5 Consent Forms and Documentation
2.5.1 Waiver or Alteration of Consent
2.5.2 Waiver of Documentation of Consent
2.5.3 Short Form Consent
2.5.4 Assent
2.6 The Clinical Trial Budget
2.7 Study Start-Up and Sponsor Documentation Requirements
2.8 The Medicare Coverage Analysis
2.9 How to Register a Clinical Trial at
2.10 Flowchart for Sequence/Timing of All Tasks in This Chapter

CHAPTER 3: Recruiting Clinical Research Subjects
3.1 Activities Preparatory to Research: Identifying and/or Contacting Subjects for Study Recruitment
3.2 Introduction to Recruiting Subjects for a Clinical Study
3.2.1 Methods for Recruiting Subjects Internally
3.3 Methods for Recruiting Subjects Externally
3.4 External Subject Recruiting Strategies Involving Direct Media
3.5 FDA Guidance Governing Direct Advertising

CHAPTER 4: Clinical Trial Conduct—A Daily Perspective
4.1 HIPAA (Health Insurance Portability and Accountability Act) and De-Identified Chart Reviews and Databases
4.2 Translation and Interpretation
4.3 Blinding and Unblinding in a Clinical Trial
4.4 Adverse Events and Reporting in a Clinical Trial
4.5 The Various Forms Used in a Clinical Trial
4.5.1 Delegation of Authority (DOA)/Delegation of Responsibility
4.6 Project Management for Clinical Trials
4.7 Coding for Clinical Trial Claims
4.8 Choosing a CTMS

CHAPTER 5: Organizations With Oversight Responsibility in Clinical Research
5.1 The Institutional Review Board
5.2 The Central Institutional Review Board
5.3 Data Safety Monitoring Board, Also Known as the Data Monitoring Committee
5.4 Clinical Endpoint Committee
5.5 Association for the Accreditation of Human Research Protection Programs, Inc
5.6 What You Need to Know About FDA Inspections, Compliance, & Enforcement

CHAPTER 6: Exceptional Circumstances in Clinical Research
6.1 Expanded Access (Compassionate Use)
6.2 Charging for an Investigational New Drug in a Clinical Trial
6.3 Emergency Use of a Test Article
6.4 Research on Decedents and PHI in Clinical Research
6.5 Vulnerable Populations
6.6 Legally Authorized Representative and Witness
6.7 What to do When a PI Departs From a Study or Institution
6.8 Consequences of Clinical Research Non-Compliance and How to Respond to Non-Compliance

CHAPTER 7: Education and Certification in Clinical Research
7.1 Bachelors and Masters Degree Programs in Clinical Research
7.2 Certification Organizations
7.3 Training Requirements for Personnel Conducting Clinical Trials

CHAPTER 8: The Newest Changes in Clinical Research
8.1 Human Subjects Protection: Acceptance of Data From Clinical Investigations for Medical Devices
8.2 The New Common Rule
8.3 Payment and Reimbursement to Research Subjects
8.4 The Single Institutional Review Board (sIRB)
8.5 New Changes to Certificates of Confidentiality
8.6 New ICH GCP E6 R2 (Revision 2) Guidelines
8.7 Electronic Common Technical Document (eCTD)
8.8 New Changes in Registration and Reporting

CHAPTER 9: After the Study Has Ended
9.1 Study Closeout
9.2 Essential Documents and Regulations for Document Retention in Clinical Research
9.3 Publishing the Results of a Clinical Research Study


APPENDICES - Found on Companion Website
1. Adverse Events Plus Reporting Table
2. Research Coordinator Work Queue
3. Feasibility Analysis Checklist
4. Contract Content Checklist
5. Consent Form Template
5.A. New Common Rule Consent Form Template
6. Per Patient Budget Template
7. Cost Reimbursable Budget Template
8. MACs by State List (2016)
9. IDE—JH and JL—Submission Checklist
10. IDE Study Criteria Checklist and Crosswalk Table
11. NIH Applicable Clinical Trial Checklist
12. Representations for Reviews Preparatory to Research
13. Screening and Enrollment Log
14. Regulatory Binder Checklist
15. Delegation of Authority/Responsibilities Log
   a. Delegation of Authority Log
   b. Delegation of Responsibility Log
16. CTMS Decision Worksheet
17. FDA Form 482 sample
18. FDA Form 483 sample
19. Two CPA Template Letters of Certification for Charging for an IND
   a. 19.A. CPA Template Letter_Charging for an IND
   b. 19.B. CPA Template Letter_Charging for an Expanded Access IND
20. Consent Question and Answer Form
21. Clinical Trials Timetable for Document Retention
22. Study Closeout Checklist
23. Quick Reference Pocket Cards
24. Medicare Coverage Analysis Flowchart
25. Subject Recruitment Tracking Log
26. Study Start Up Checklist
27. Assent Form Templates
   a. 27.A. Assent for Children Ages 7-11 Years Old
   b. 27. B. Assent for Children Ages 12 – Age of Adulthood
28. 45 CFR 46 Subpart A Common Rule Revision Comparison Document
29. PI Notification of Study Enrollment to PCP
30. Example of PI Marketing Letter
31. Checklist for Emergency Use of a Test Article
32. Sample letter to the IRB for Notification of Emergency Use of a Test Article
33. Resource Links
34. Clinical Trial Site Scorecard
35. FDA Form 3454
36. FDA Form 3455
37. CDA/NDA Template
38. FDA Audit Documentation Checklist


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© Academic Press 2018
8th August 2018
Academic Press
Paperback ISBN:
eBook ISBN:

About the Authors

Natasha Martien

Natasha Martien, MBA, CCRP, SSBBP, CRCP, is a Human Subjects Research regulatory expert with 25 years of clinical research and healthcare management experience at institutes including Johns Hopkins Hospital, The Center for Cardiac and Vascular Research, and Scripps Clinic and Research Foundation. Martien has performed every operational role in clinical research at sites, including: training IRB members, Investigators and Research Coordinators; regulatory management; working for Naan Office of Human Research Protections supporting an IRB; Research Coordination; writing and negotiating clinical trial agreements and budgets; financial management and billing; Coverage Analysis; CTMS acquisition; data analysis; credentialing; Quality Assurance; writing consent forms and study materials; compliance; advertising and recruiting; and the creation of a Clinical Trials Office. Martien has conducted and managed Investigator Initiated, Industry and Grant funded studies in 24 medical disciplines and for all study types, such as INDs, IDEs, biologics, stem cells, behavioral, pilot, observational, chart reviews and clinical trial Phases I through IV.

Affiliations and Expertise

Human Subjects Research regulatory expert

Jeff Nelligan

Jeff Nelligan, J.D., is a Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience in three Federal Cabinet Agencies and in the Legislative branch, including: as a Director at the Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of Health and Human Services; as a Managing Director at the U.S. Government Accountability Office (GAO); and, as a senior staffer for three Members of Congress in the U.S. Senate and the U.S. House of Representatives. He is a graduate of Williams College and Georgetown University Law Center.

Affiliations and Expertise

Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience

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