Common use of Accountability Procedures Clause in Contracts

Accountability Procedures. Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the study, designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the 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 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 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 IPs, the Investigator investigator or delegate must conduct an inventory. During the study, designated the masked investigator must designate study staff must to provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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 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 AE 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 MOP for 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 IPs, the Investigator or delegate must conduct an inventory. During the study, unmasked designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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. 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 AE 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 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 IPs, the Investigator or delegate must conduct an inventory. During the study, designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the 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 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 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 IPs, the Investigator or delegate must conduct an inventory. During the study, unmasked designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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. 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 AE 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 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 IPsIP, the Investigator or delegate must conduct an inventory. During the study, designated study Masked Investigator must designate unmasked staff must to provide the IPs IP to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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 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 AE 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 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 IPs, the Investigator or delegate must conduct an inventory. During the study, unmasked designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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. 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 IPsIP, the Investigator or delegate must conduct an inventory. During the study, designated study Masked Investigator must designate unmasked staff must to provide the IPs IP to the subjects in accordance with their randomization assignment. Throughout the study, the designated study staff 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 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 AE 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 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.