Conduct Policy and Guidance

Conduct of all DF/HCC clinical trials must follow all DF/HCC Policies and Operations. The Office of Human Research Studies (OHRS) and The Office of Data Quality (ODQ) have created various guidance documents and information sheets to assist researchers in the management of their studies. ODQ also offers data management services for investigator-sponsored studies. Serious Adverse Event Reporting and Continuing Review requirements are essential elements of trial conduct. The Clinical Operations Committee (CLINOPS) provides a forum for research management at the DF/HCC member institutions.

This section provides information and required documents for policies and guidance associated with protocol conduct.