Author: Karen E. Woodin, Ph.D., and John C. Schneider

The CRA’s Guide to Monitoring Clinical Research is an excellent resource for both the novice and experienced CRA. It provides an explanation of the research process and the regulations that govern clinical research, along with helpful hints and tips, checklists, personal experiences and more! After reading this guidebook, you will be able to describe the role of the CRA including responsibilities and role significance. The CRA’s Guide teaches you to demonstrate how regulations, GCPs, and SOPs can be applied to everyday operations of conducting and monitoring clinical trials. The manual will discuss how monitoring responsibilities vary based on the different phases within a clinical trial and assess the importance of the informed consent process including its working relationship with IRBs, research centers and patients to operate a safe and ethical clinical trial.

Book topics:

• Preparing for a study and selecting investigators
• Obtaining and monitoring informed consent
• Preparing for a monitoring visit
• Recruiting and retaining study subjects
• Conducting adverse event and safety monitoring
• Preparing for audits and detecting fraud

Book also includes the following guidelines and worksheets:

• 21 CFR Parts 50, 54, 56 & 312 Guidelines
• Monitoring visit checklist, site evaluation checklist, and informed consent checklist
• Study Documentation File Verification Log
• 1572 Form

Perfect for:

• Novice and experienced CRAs
• Health professionals interested in pursuing a career as a study monitor
• Instructors conducting training and educational programs