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, it is recommended that the investigator delegates staff to provide the IPs to the subjects in accordance with their randomization assignment. All members associated with the study at the site should make an attempt to remain masked, except for designated staff who will be dispensing IP and completing IP dispensation and collection records. These records 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 unused products are available for return to the study sponsor, as directed • All used lidding foils are available for return to the study sponsor, as directed Unscheduled Visits and Early Termination Visits are allowed, if necessary. Study lenses will be provided to the subjects to take home for daily wear during the course of the trial. Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lenses. If a subject cannot be successfully fit (either study lens) according to the study lens fitting guides as determined by the investigator, they will be required to exit from the study. Lubrication/rewetting drops will not be permitted during this study.

Accountability Procedures. Upon receipt of the IPs, the investigator Investigator or delegate must conduct an inventory. During the study, it is recommended that the investigator delegates unmasked designated study staff to must provide the IPs to the subjects in accordance with their randomization assignment. All members associated with Throughout the study, the unmasked designated study at the site should make an attempt to remain masked, except for designated staff who will be dispensing IP and completing must maintain records of IP dispensation and collection recordsfor each subject. These records 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. 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 • All used lidding foils Any study lenses associated with a device deficiency or with any product-related AE (ie, ADE or SADE) are available for return 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 sponsor, as directed Unscheduled Visits products associated with these events. • Every effort should be made to return opened and Early Termination Visits unopened investigational lenses from those subjects lost to follow-up. • All supplies are allowed, if necessary. Study lenses will to be provided to retrieved from the subjects to take home for daily wear during subject at the course of the trial. Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lensesfinal visit. If a subject cannot misses the final visit, all efforts MUST be successfully fit (either study lens) made to reschedule the final visit provided it is scheduled within the visit window. The Investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the study lens fitting guides as determined by instructions provided in the investigator, they will be required to exit from the study. Lubrication/rewetting drops will not be permitted during this studyMOP.