2 .3 Description J1790 / Version 7.0 / December 10, 2020 47 8.2 .4 Packaging and Labeling Information - - - - 8. 2 .5 Preparation 8. 2 .6 Storage 8. 2 .7 Stability 8. 2 .8 Route of Administration 8. 2 .9 Subject Care Implications J1790 / Version 7.0 / December 10, 2020 48 8. 2 . 10 Returns and Reconciliation The investigator is responsible for keeping accurate rec ords of the clinical supplies, the amount dispensed to, and returned by the subjects and the amount remaining at the conclusion of the trial. Upon co m pletion or ter m ination of the study, all unused and/or partially used investigational product will be des troyed at the site per institutional policy. It is the Investigat o r ’s respon s ibility to arrange for disposal of all empty containers, provided that procedures for proper disposal have been established according to applicable federal, state, local and institutional guidelines and procedures, and provided that appropriate records of disposal are kept. 8.3 CRS - 207 8. 3 .1 Agent Accountability The IND S ponsor or the IND Sponsor’s representative shall take responsibility for and shall take all steps to maintain appropriate records and ensure appropriate supply, storage, handling, distribution and usage of investigational product in accordance with the protocol and any applicable laws and regulations. 8.