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The Sourcebook for Clinical Research

A Practical Guide for Study Conduct

  • 1st Edition - August 1, 2018
  • Latest edition
  • Authors: Jeff Nelligan, Natasha Martien
  • Language: English

A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has ex… Read more

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Description

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: https://www-elsevier-com.ucc.idm.oclc.org/books-and-journals/book-companion/9780128162422/order-display-posters. 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

Readership

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 Requirements1.1 What is the Purpose of Medical Research?1.2 Defining the Types of Research Studies1.3 Mandatory Regulations and ICH GCP (International Council for Harmonisation Good Clinical Practice) Ethical Guidelines1.4 How to Secure a Clinical Trial and How to Market Your Medical Facility to Sponsors1.5 Principal Investigator (PI) Responsibilities1.6 Research Coordinator (RC) Responsibilities1.7 Understanding the Role of HIPAA and PHI in Clinical Research Endnotes

CHAPTER 2: Preparation Before a Clinical Trial Begins2.1 Clinical Trial Feasibility Analysis2.2 Financial Conflict of Interest Regulations in a Clinical Trial2.3 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 Documentation2.5.1 Waiver or Alteration of Consent2.5.2 Waiver of Documentation of Consent2.5.3 Short Form Consent2.5.4 Assent2.6 The Clinical Trial Budget2.7 Study Start-Up and Sponsor Documentation Requirements2.8 The Medicare Coverage Analysis2.9 How to Register a Clinical Trial at www.ClinicalTrials.gov2.10 Flowchart for Sequence/Timing of All Tasks in This Chapter

CHAPTER 3: Recruiting Clinical Research Subjects3.1 Activities Preparatory to Research: Identifying and/or Contacting Subjects for Study Recruitment3.2 Introduction to Recruiting Subjects for a Clinical Study3.2.1 Methods for Recruiting Subjects Internally3.3 Methods for Recruiting Subjects Externally3.4 External Subject Recruiting Strategies Involving Direct Media3.5 FDA Guidance Governing Direct Advertising

CHAPTER 4: Clinical Trial Conduct—A Daily Perspective4.1 HIPAA (Health Insurance Portability and Accountability Act) and De-Identified Chart Reviews and Databases4.2 Translation and Interpretation4.3 Blinding and Unblinding in a Clinical Trial4.4 Adverse Events and Reporting in a Clinical Trial4.5 The Various Forms Used in a Clinical Trial4.5.1 Delegation of Authority (DOA)/Delegation of Responsibility4.6 Project Management for Clinical Trials4.7 Coding for Clinical Trial Claims4.8 Choosing a CTMS

CHAPTER 5: Organizations With Oversight Responsibility in Clinical Research5.1 The Institutional Review Board5.2 The Central Institutional Review Board5.3 Data Safety Monitoring Board, Also Known as the Data Monitoring Committee5.4 Clinical Endpoint Committee5.5 Association for the Accreditation of Human Research Protection Programs, Inc5.6 What You Need to Know About FDA Inspections, Compliance, & Enforcement

CHAPTER 6: Exceptional Circumstances in Clinical Research6.1 Expanded Access (Compassionate Use)6.2 Charging for an Investigational New Drug in a Clinical Trial6.3 Emergency Use of a Test Article6.4 Research on Decedents and PHI in Clinical Research6.5 Vulnerable Populations6.6 Legally Authorized Representative and Witness6.7 What to do When a PI Departs From a Study or Institution6.8 Consequences of Clinical Research Non-Compliance and How to Respond to Non-Compliance

CHAPTER 7: Education and Certification in Clinical Research7.1 Bachelors and Masters Degree Programs in Clinical Research7.2 Certification Organizations7.3 Training Requirements for Personnel Conducting Clinical Trials

CHAPTER 8: The Newest Changes in Clinical Research8.1 Human Subjects Protection: Acceptance of Data From Clinical Investigations for Medical Devices8.2 The New Common Rule8.3 Payment and Reimbursement to Research Subjects8.4 The Single Institutional Review Board (sIRB)8.5 New Changes to Certificates of Confidentiality8.6 New ICH GCP E6 R2 (Revision 2) Guidelines8.7 Electronic Common Technical Document (eCTD)8.8 New Changes in ClincialTrials.gov Registration and Reporting

CHAPTER 9: After the Study Has Ended9.1 Study Closeout9.2 Essential Documents and Regulations for Document Retention in Clinical Research9.3 Publishing the Results of a Clinical Research Study

APPENDICES - Found on Companion Website1. Adverse Events Plus Reporting Table2. Research Coordinator Work Queue3. Feasibility Analysis Checklist4. Contract Content Checklist5. Consent Form Template5.A. New Common Rule Consent Form Template6. Per Patient Budget Template7. Cost Reimbursable Budget Template8. MACs by State List (2016)9. IDE—JH and JL—Submission Checklist10. IDE Study Criteria Checklist and Crosswalk Table11. ClinicalTrials.gov NIH Applicable Clinical Trial Checklist12. Representations for Reviews Preparatory to Research13. Screening and Enrollment Log14. Regulatory Binder Checklist15. Delegation of Authority/Responsibilities Log a. Delegation of Authority Log b. Delegation of Responsibility Log16. CTMS Decision Worksheet17. FDA Form 482 sample18. FDA Form 483 sample19. 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 IND20. Consent Question and Answer Form21. Clinical Trials Timetable for Document Retention22. Study Closeout Checklist23. Quick Reference Pocket Cards24. Medicare Coverage Analysis Flowchart25. Subject Recruitment Tracking Log26. Study Start Up Checklist27. Assent Form Templates a. 27.A. Assent for Children Ages 7-11 Years Old b. 27. B. Assent for Children Ages 12 – Age of Adulthood28. 45 CFR 46 Subpart A Common Rule Revision Comparison Document29. PI Notification of Study Enrollment to PCP30. Example of PI Marketing Letter31. Checklist for Emergency Use of a Test Article32. Sample letter to the IRB for Notification of Emergency Use of a Test Article33. Resource Links34. Clinical Trial Site Scorecard35. FDA Form 345436. FDA Form 345537. CDA/NDA Template38. FDA Audit Documentation Checklist

Product details

  • Edition: 1
  • Latest edition
  • Published: August 8, 2018
  • Language: English

About the authors

JN

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

NM

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

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