INVESTIGATOR AGREEMENT FOR A CLINICAL INVESTIGATION OF THE (Specify Investigational Device) (Protocol Number and Study Title)Investigator Agreement • September 8th, 2023
Contract Type FiledSeptember 8th, 2023Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
GEORGIA INSTITUTE OF TECHNOLOGY INSTITUTIONAL REVIEW BOARD INVESTIGATOR AGREEMENT FOR A CLINICAL INVESTIGATION OF THE (Specify Investigational Device) (Protocol Number and Study Title)Investigator Agreement • May 5th, 2020
Contract Type FiledMay 5th, 2020Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.