The Sourcebook for Clinical Research

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 www.ClinicalTrials.gov
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

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. 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