Most noncompliance stems from inadequate and inconsistent documentation at sites. In this always-popular full-day workshop, you will learn techniques to better manage your regulatory files and prepare to answer sponsors and inspectors regarding screening/enrollment numbers, subject withdrawal, informed consent, recruitment efforts, delegation of authority, PI oversight, protocol violations, and adverse events through the use of adequate source. Explore methods by which one can assess feasibility to determine if a study is a good fit for your site. Speakers will provide tips for managing the regulatory file through tools/worksheets/templates and interactive activities. More than 200 pages of templates and tools will be provided. These techniques and tools will position your site to be best prepared for a monitoring visit or site audit/inspection.
To register, select Workshop 005. NOTE: Workshops at not included with Full-Conference Registration and require a separate registration fee.
Contact Hours / CEUs: 7.0 (ACRP)