When registering for this workshop (additional fee required), please be sure to select “WS1” on your registration form.
Mirror, Mirror, on the wall, who’s the fairest site of all? Most noncompliance stems from inadequate and inconsistent documentation at sites. 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. Tips for managing the regulatory file will be provided through tools/worksheets/templates and interactive activities. Over 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. Be prepared and be preferred!
Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant
Deborah Rosenbaum, CCRC, CCRA, CCRP, FACRP, Clinical Research Consultant, Sarrison Clinical Research