This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.
Offers certifications for clinical research professionals including CCRC® – Certified Clinical Research Coordinator, CCRA® – Certified Clinical Research Associate, and CPI® – Certified Physician Investigator
- Now offering a new Certified Professional credential, ACRP-CP®
FDA Form 3500A: For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting
NOTE: might need to choose Open with Adobe Acrobat, opening with browser might not work
This comprehensive guide offers CRCs, and those who would like to become CRCs, the information they need to successfully coordinate a clinical trial from study startup to closeout and beyond. Book jacket.
Recommended by the National Institutes of Health, the Office of Health and Human Services and the FDA, Protecting Study Volunteers in Research is a 250-page manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers. This convenient and portable manual has become required reading in academic institutions, IRBs and independent investigative sites. Many sponsor and CRO companies have also made this manual mandatory reading for their staff and service providers. Developed in accordance with the essentials and standards of the ACCME, readers can apply for CME credits or Nursing Credit Hours. An exam is provided with each manual. pics include... Historical perspectives on human subject research; Ethics and federal regulations; Roles and responsibilities of institutions and independent sites; Roles and responsibilities of investigators and study staff.