160.33—Study director.
For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. The study director shall assure that:
(b)
All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c)
Unforseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
(f)
All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.