The PI's Guide to Conducting Clinical Research

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