The Sourcebook For Clinical Research

The Sourcebook for Clinical Research Book Summary

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 process Lays out vital information in an easy, accessible format to keep investigative teams current on federal regulations and good clinical practice Provides 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