Acknowledgments

Foreword

Introduction

Federal Regulations Governing the Obligations of Clinical Investigators of Regulated Articles

The Clinical Research Organization

Contract Research Organizations and Site Management Organizations
Good Clinical Practice Guidelines
Declaration of Helsinki
Sponsor of a Clinical Trial

Investigator Responsibilities

Condensed Version
Clinical Trial Monitoring of Documentation
Investigator Responsibilities

Duties of the Clinical Research Coordinator

Compiling Prestudy Documents
Creating and Maintaining Study Files
Obtaining CLIA Laboratory Certification as It Pertains to Clinical Research

The Creation of Study Source Documents

Source Documents – What Are They?
Source Document Examples
Types of Medical Reports Generated While a Subject Is Enrolled in a Study
Good Clinical Research Documentation Details
Source Documentation Suggestions
Meeting the Requirements of Source Documentation
Data Clarification and Adverse Event Reporting
Queries
Identifying Data Problems

Obtaining Informed Consent and Assent Approval

Obtaining Informed Consent
Obtaining Institutional Review Board Approvals
Reviewing the Protocol and Obtaining Signatures
HIPAA Regulations and Clinical Research
Clinical Research: Study Assent in Adolescents/Children

Pertinent Forms and Study Records

The Test Article Inventory System
The Drug Accountability Record
Paper Case Report Forms
Authorized Representative Signature Record (Site Signature Log)
The Adverse Experience Form
Specimen Handling and Submission Forms
The Subject Enrollment Form
The Site Visit Log (Monitor Log)
The Telephone Log
Delegation of Authority Log

The Prestudy Site Visit

Site Initiation Visit

Recruiting and Enrolling Subjects

Prospective Subject Groups
Methods of Publicizing the Study
Presenting the Study to the Subject

Conducting the Study and Keeping Records

Study Activities
Subjects Lost to Follow-Up
Withdrawing a Subject
Site Visits During the Study
Closing the Study and Retaining Records

Preparing for an FDA Audit

FDA Inspections of Clinical Trials
Types of FDA Inspections
Parts of the Investigation
Preparation and Instructions for an FDA Audit
Common FDA Inspection Findings
Common Problems Identified in Audits of Clinical Trials

Clinical Research: Potential Liability

Fraud
Negligence
Legal Liability and the Clinical Research Coordinator

Writing the Study Summary

Biostatistical Report
Integrated Clinical Study Report
Articles for Publication

Achieving Credibility and Recognition as a Clinical Research Coordinator

Attending Investigator Meetings
How to Work With a Difficult Clinical Research Associate
Electronic Data Capture and Clinical Trials

Appendices

Appendix I: Helpful Sources

Names and Addresses of Clinical Research Resources
Important FDA Websites for Institutional Review Boards and Clinical Investigators

Appendix II: Forms Used During the Course of a Clinical Study

Form 1. Information Regarding Participation in a Clinical Trial
Form 2. The Statement of Investigator Form (FDA 1572)
Form 3. Bill of Rights for Study Subject Volunteers
Form 4. The MedWatch Adverse Experience Form
Form 5. Informed Consent Form
Form 6. The Administrative Checklist
Form 7. Initial Adverse Experience Report Sheet
Form 8. Source Sample Telephone Log
Form 9. Sample Study Advertisement Office Sign
Form 10. Sample Screen Visit Letter
Form 11. Sample Baseline Visit Letter
Form 12. Ongoing Study Visit Letter
Form 13. Sample Final Study Letter
Form 14. Sample Financial Disclosure Certification Form
Form 15. Sample HIPAA Authorization to Access Protected Health Information
Form 16. STOP: Before Any Med Changes
Form 17. STOP: This Patient Is a Participant in a Research Project
Form 18. Transporting Study Material from Main Site to Satellite Sites
Form 19. Sample Principal Investigator Delegation of Responsibility Form
Form 20. Sample Curriculum View Form
Form 21. Patient Assent Form

Appendix III: Conversion Tables

Conversion to Military Time
Measures and Equivalents
Conversion Charts for Height and Weight Measurements

Appendix IV: Common Terms and Acronyms
Appendix V: Glossary of Terms

About the Author