The PI's Guide to Conducting Clinical Research, Second Edition

Product Description As the clinical research enterprise continues to evolve at a rapid pace, the physician investigator is charged with meeting the demands of conducting faster clinical trials, adhering to stricter requirements from sponsors and regulatory bodies and managing increased competition in the market all while maintaining the highest quality and patient safety standards. The PI s Guide to Conducting Clinical Research, first published in 1997 and previously titled Becoming a Successful Clinical Research Investigator, 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. Investigators will learn to: -Understand investigator responsibilities from practical and ethical study conduct to site and financial management -Secure new clinical studies, assess feasibility and create study budgets Comply with changing federal regulatory guidelines -Practice ICH-GCP guidelines Implement and adhere to strict standard operating procedures -Recruit and retain study volunteers Understand informed consent and human subject protection -Prepare for sponsor or IRB audits -Prepare for certification exams and more Recommended for: -Physician 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 -Sponsors, CROs, SMOs and academic institutions interested in providing a reference manual for their investigators About the Author Elizabeth Weeks-Rowe, LVN, CCRA, has spent over 18 years in a variety of clinical research roles including study coordinator, CRA, CRA trainer, CRA manager and clinical research writer. She has developed training content and presented clinical research topics for leading industry training and education organizations. She has created marketing content, website content and clinical operations newsletters for European and U.S.-based clinical research organizations. She is a contributing writer for several leading industry publications, including a recurring clinical research column for a leading clinical research news publication. She has authored a white paper on best industry practices for co-monitoring assessments, and unblinded pharmacy monitoring/ monitoring practice. She is the author of a clinical research novella entitled, Clinical Research Trials and Triumphs; a heart warming novel following a nurse s journey into clinical research. She is an instructor for a well known clinical research training company and speaks at global industry clinical research meetings. For the last 7 years, she has worked in a critical site selection and training role for a leading CRO.