Accountability Procedures. 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.
Appears in 1 contract
Sources: Investigator Agreement
Accountability Procedures. It is the investigatorInvestigator’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 sponsorStudy Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event AE (i.e.ie, 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 Investigator is responsible for proper disposition of all unused IPs at the return conclusion of study products associated with these events.the study,
Appears in 1 contract
Sources: Investigator Agreement
Accountability Procedures. It is the investigatorInvestigator’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 sponsorStudy Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event AE (i.e.ie, 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 Investigator is responsible for proper disposition of all unused IPs at the return conclusion of study products associated with these events.the study,
Appears in 1 contract
Sources: Investigator Agreement