The CRA’s Guide to Monitoring Clinical Research, Sixth Edition

Job confidence. Job advancement. Training for new CRAs.

Keep your clinical research practices up to date with the newest edition of The CRA’s Guide to Monitoring Clinical Research. CRAs are currently facing a rapidly changing industry amidst technological advancements, new research methods, and the recent global pandemic. The sixth edition of this manual provides the most current and robust overview of the CRA role to help both novice and experienced CRAs navigate these transitions.

The guide examines the career outlook for CRAs as the clinical research industry becomes more global and technologically focused. As with past editions, specific FDA regulations, best clinical practices standards, and other crucial areas are closely examined, while chapters are also updated throughout to focus on new and developing areas, including:

• Decentralized trial methods
• Diversity and inclusion
• New clinical research site models
• Remote monitoring
• CRA Training

Throughout, you’ll gain helpful tips, strategies, checklists, and training resources to help you build job confidence and advance your career. You’ll learn about:

• Study initiation, monitoring and closeout
• Stages of clinical research and phases of trials
• Adverse events and safety monitoring
• Statistical methods
• IRB review and reporting
• Inspections and audits
• Informed consent process
• Background and principles of good clinical practice (GCP)
• FDA regulations and guidance on clinical trial monitoring
• Post-COVID adjustments and implications
• Stakeholders the CRA must work with
• New technologies to capture and manage data
• Development of new roles in clinical trials

Get answers on your most-asked clinical research questions and accelerate your CRA career today with the sixth edition of The CRA’s Guide to Monitoring Clinical Research, a training and educational tool sure to be a mainstay of your reference library.

About the Contributor

Elizabeth Weeks-Rowe is an independent clinical research consultant who provides CRA training, content creation, and clinical operations support services. She has more than 20 years of diverse clinical research experience as a study coordinator, CRA, CRA trainer and CRA manager, and authored the 2016 and 2019 updates to The CRAs Guide to Monitoring Clinical Research and the 2019 update to The PI’s Guide to Conducting Clinical Research.