The Office of the Clinical Director includes the Office of Clinical Affairs for protocol, IRB and DSMB support, and prtocol monitors and FDA regulatory expertise under contract with SAIC-Frederick. Activities of the Office include receipt of protocols by an electronic submission system, selecting scientific and biostatistic reviewers, performing a pre-IRB review of content and organization, submission to IRB after satisfactory responses from investigators and submittint approved protocol to the Office of Protocol Service. The Office also interacts with eth Office of Human Subjects Research Protections, especially regarding unexpected serious adverse events possible related to research participation. In the comining year, the Office will also provide protocol navigators and data managers to research teams.
