 On-site audits may take place and are independent of and separate from routine monitoring or quality control functions. They may take place at various stages during the registry. The clinical investigators will be informed in writing andor by telephone in a timely manner that an independent audit is to take place along with the scope of the audit, a date and timelines involved. Whenever possible, the auditor will be accompanied by the responsible CRA or Sponsors representative. The auditor may stay at the registry site as long as deemed necessary. 