Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:

• failure to obtain/maintain approval for research,
• failure to obtain informed consent when required,
• failure to file adverse event reports,
• performance of an unapproved study procedure,
• performance of research at an unapproved site,
• failure to file protocol modifications and
• failure to adhere to an approved protocol.