Product Details
The principal investigator is charged with meeting the demands of conducting faster clinical trials… adhering to stricter requirements from sponsors and regulatory bodies… managing increased competition in the market… all while maintaining the highest quality and patient safety standards.
The PI’s Guide to Conducting Clinical Research is the only industry resource designed to assist both novice and experienced PIs in meeting these higher, more challenging expectations to conduct better, safer and more efficient clinical trials.
In this edition:
- The impact of Common Rule and ICH E6 revisions
- Inspections and audits of investigators and their sites
- New requirements for oversight of investigational drugs
- Challenges involved in maintaining electronic systems and ensuring compliance
- Delegation of authority and oversight of sub-investigators
- The role of registry studies and retrospective data collection studies
- Informed consent training of staff
- Coordinating with testing centers
- Innovative patient recruiting methods
- Risk-based and remote monitoring methods
This guide is packed with information regarding your responsibilities including practical and ethical study conduct, site and financial management, and responsibilities imposed by ICH E6(R2). It’s your guide to understanding 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
Order your copy today!
Who Will Benefit
- Physician investigators, principal investigators, sub-investigators and clinical research scientists interested in or already conducting clinical trials for pharmaceutical or biotech companies
- Instructors conducting clinical research training and educational programs
- Professors or researchers developing college curriculums
About the Author
Elizabeth Weeks-Rowe is an experienced CRA and clinical trial consultant. The author of the fifth edition of The CRA’s Guide to Monitoring Clinical Research, she has 20 years of experience conducting and monitoring clinical trials.
Softcover
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Author:
Elizabeth Weeks-Rowe
ISBN-13:
978-1-60430-101-4
Publication date:
October 2019
Page count:
574