Common use of Accountability Procedures Clause in Contracts

Accountability Procedures. Upon receipt of the IP, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator must designate unmasked staff to provide the IP to the subjects in accordance with their randomization assignment. 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 IP must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • 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 (ie, 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 IP, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator must designate unmasked staff to provide the IP to the subjects in accordance with their randomization assignment. 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 IP must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: •  All study products are accounted for and not used in any unauthorized manner •  All used foils and unused supplies are returned by each subject •  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 (ie, 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 IPIPs, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator designated study staff must designate unmasked staff to provide the IP IPs to the subjects in accordance with their randomization assignment. Throughout the study, the Investigator or delegate designated study staff 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 IP IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • 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 AE (ie, 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 MOP for 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 IPIPs, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator unmasked designated study staff must designate unmasked staff to provide the IP IPs to the subjects in accordance with their randomization assignment. 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 IP IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • 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 AE (ie, 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 IPIPs, the Investigator investigator or delegate must conduct an inventory. During the study, Masked Investigator the masked investigator must designate unmasked study staff to provide the IP IPs to the subjects in accordance with their randomization assignment. Throughout the study, the Investigator 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 IP IPs sent to the investigator must be accounted for by Study Sponsor 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 Investigatorinvestigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • All unused products are available for return to the Study Sponsorstudy sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event (iei.e., ADE or SADE) are returned to the Study Sponsor study sponsor for investigation, unless otherwise directed by the Sponsorsponsor. 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 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 IPIPs, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator unmasked designated study staff must designate unmasked staff to provide the IP IPs to the subjects in accordance with their randomization assignment. 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 IP IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • 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 (ie, 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 IPIPs, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator designated study staff must designate unmasked staff to provide the IP IPs to the subjects in accordance with their randomization assignment. Throughout the study, the Investigator or delegate designated study staff 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 IP IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: •  All study products are accounted for and not used in any unauthorized manner •  All used foils and unused supplies are returned by each subject •  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 AE (ie, 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 MOP for 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 IPIPs, the Investigator or delegate must conduct an inventory. During the study, Masked Investigator unmasked designated study staff must designate unmasked staff to provide the IP IPs to the subjects in accordance with their randomization assignment. 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 IP IPs sent to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized situation. It is the Investigator’s responsibility to ensure that: •  All study products are accounted for and not used in any unauthorized manner •  All used foils and unused supplies are returned by each subject •  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 (ie, 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.