Now Available!

In clinical research, the primary mission of the principal investigator is to conduct fast and efficient clinical trials — all while adhering to stricter requirements from sponsors and regulatory bodies, and maintaining the highest quality and patient safety standards.

Just released in its Third Edition, The PI’s Guide to Conducting Clinical Research is the ideal resource to direct PIs on their evolving responsibilities. This includes taking a deep dive into practical and ethical study conduct, site and financial management, and responsibilities imposed by ICH E6(R3).

In the comprehensively updated Third Edition, PIs at any point in their careers will find insights on:

• The impact of the COVID-19 pandemic on clinical research.
• Post-pandemic adoption of virtual patient visits as a standard practice.
• Increased use of decentralized trials.
• The impact of Common Rule and ICH E6 revisions, including R3.
• Discussion of the challenges involved in maintaining electronic systems and ensuring data compliance.
• Delegation of authority and oversight of sub-investigators.
• Informed consent training of staff.
• Innovative patient recruiting methods.
• Risk-based and remote monitoring methods.

An industry mainstay for the past decade, the new edition of The PI’s Guide to Conducting Clinical Research is the fundamental resource for gaining an in-depth understanding in how to:

• Secure new clinical studies, assess feasibility and create study budgets.
• Comply with changing federal regulatory guidelines.
• Implement and adhere to strict standard operating procedures.
• Recruit and retain study volunteers.
• Conduct informed consent and protect human subjects.
• Prepare for sponsor or IRB audits.
• Prepare for certification exams.

Enhance the impact of your contributions to clinical trials by adopting best practices as a principal investigator. The PI’s Guide to Conducting Clinical Research, Third Edition will show you how.

Order your copy today!

About the Author

Elizabeth Weeks-Rowe, LVN, CCRA, is an experienced CRA and clinical trial consultant. The author of the sixth edition of The CRA’s Guide to Monitoring Clinical Research and the second edition of The PI’s Guide to Conducting Clinical Research, she has more than 20 years of experience conducting and monitoring clinical trials.