Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.
Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;
Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.
Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;
Study means the investigation to be conducted in accordance with the Protocol.