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 providing an explanation of the research process, from beginning to end, and the regulations that govern clinical research. This training guide also offers helpful hints and tips, checklists, personal experiences, and detailed discussions, including how monitoring responsibilities vary and the importance of the informed consent process and its relationship to IRBs, research centers, and patients to operate a safe and ethical clinical trial.

Topics include:

• 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

Recommended for:

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