Noncompliance

Any failure to follow: 1) applicable federal regulations, state or local laws, institutional policies, or other institutional oversight governing human subject protections, or 2) the requirements or determinations of the IRB, including the requirements of the approved protocol (i.e., a protocol deviation(s)). Noncompliance can result from performing an act that violates these requirements or failing to act when required. Noncompliance may be minor or sporadic or it may be serious or continuing. Any noncompliance that is not potential Serious Noncompliance nor Continuing Noncompliance is not Promptly Reportable Information (PRI) and must be documented in the research record (e.g., study deviation log) with a Corrective and Preventive Action (CAPA) Plan, as applicable. UNC-Chapel Hill OHRE SOP 1401