The QI Virtual Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:
The Virtual Regulatory Binder is comprised of sections that apply to the range of human subject studies. Each binder section outlines the regulatory requirements, institutional policies and GCP guidelines for organization and recordkeeping. At the bottom of each section are QI tips and links to additional resources (e.g., federal regulations, policies and forms, QI tools).