Food and Drug Regulations

C.08.017 An experimental studies investigator shall

• (a) use the new drug only in accordance with the outline of the experimental study;

• (b) report immediately to the Director all serious adverse drug reactions associated with the use of the new drug;

• (c) report promptly to the Director, on request, the results of the experimental study;

• (d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

• (e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;

• (f) report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and

• (g) account to the Director, on request, for all quantities of the new drug received by him.