The CRC will work with investigators, study staff, Scientific Review Committee (SRC) and institutional review boards (IRB), clinical trial sponsors and federal regulatory agencies to assure compliance with study protocols, data documentation, reporting requirements, ensure that regulatory requirements for clinical trials are met. Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc.