Common use of Accountability Procedures Clause in Contracts

Accountability Procedures. Upon receipt of the IPs, the investigator or delegate must conduct an inventory. Throughout the study, the investigator or delegate must maintain records of IP dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the investigator must be accounted for by study sponsor personnel, and in no case be used in an unauthorized situation. The investigator should make every effort to collect unused lenses, foils, and supplies from subjects. It is the investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All unused products are available for return to the study sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events. The investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the MOP.

Accountability Procedures. Upon receipt of the IPs, the investigator or delegate must conduct an inventory. Throughout the study, the investigator or delegate must maintain records of IP dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. All IPs sent to the investigator must be accounted for by study sponsor personnel, and in no case be used in an unauthorized situation. The investigator should make every effort to collect unused lenses, foils, and supplies from subjects. It is the investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All unused products are available for return to the study sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events. The investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the MOP. 9.6 Changes to concomitant medications, treatments/ procedures