This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.
- 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
Please Note: This is an On Demand product, delivery may take up to 11 working days after payment has been received.
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 [external URL] 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 ClincialTrials.gov 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
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. ClinicalTrials.gov 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
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.
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.