The Sourcebook for Clinical Research: A Practical Guide for Study Conduct

A clinical trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines, and specific protocol instructions to follow. The Sourcebook for Clinical Trials provides a comprehensive overview of the clinical trial process covering the basics to more advances topics. The book discusses foundational elements defining clinical trials and types of research studies, research personnel and responsibilities, and understanding the role of HIPAA and PHI. The book also covers pre-trial preparation and regulatory requirements, subject recruitment, mechanics and trial conduct, review boards and agencies involved in the clinical trial process as well as post-trial study closeout. The inclusion of helpful resources, sample forms, and checklists make The Sourcebook for Clinical Trials an essential step-by-step resource for those involved in conducting, managing, or overseeing clinical trials.

Offers guidance that is crucial for guaranteeing compliance to clinical trial protocols during each stage of the clinical trial processLays out vital information in an easy, accessible format to keep investigative teams current on federal regulations and good clinical practiceProvides up-to-date and extensive coverage of Federal and IRB regulations and helpful worksheets, templates, checklists, and protocol resources for clinical trial personnel to utilize

1. Foundational Elements and Regulatory Requirements 2. Preparation Before a Clinical Trial Begins 3. Recruiting Clinical Research Subjects 4. Clinical Trial Conduct—A Daily Perspective 5. Organizations With Oversight Responsibility in Clinical Research 6. Exceptional Circumstances in Clinical Research 7. Education and Certification in Clinical Research 8. The Newest Changes in Clinical Research 9. After the Study Has Ended