Common use of Subject Confidentiality and Methods Used to Minimize Bias Clause in Contracts

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor.‌‌‌ This study is double-masked with subjects randomized to use both DD T2 and the assigned control product (in a randomized sequence) for the duration of the treatment period. The Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial.

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor.‌‌‌ Sponsor. This study is double-masked with subjects randomized to use both DD T2 and the assigned control product (in a randomized sequence) for the duration of the treatment period. The Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial. ‌‌‌ Alcon - Business Use Only Protocol - Clinical‌‌‌ Effective Date: 02-Nov-2017 Document: TDOC-0054506 Status: Effective Version: 1.0; CURRENT; Most-Recent; Effective Page 36 of 38 It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the eCRF are consistent with the original source data. Only designated individuals may complete the eCRFs. The eCRFs will be submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The Principal Investigator is responsible for reviewing and certifying that the eCRFs are accurate and complete. The only subject identifiers recorded on the eCRFs will be subject number, and subject demographic information.

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor.‌‌‌ sponsor. This study is double-masked with subjects randomized to use both DD T2 and the assigned control product (in a randomized sequence) PRECISION1 or INFUSE for the duration of one-week treatment period and then crossover and use the other study product for one-week treatment period. The Investigator subjects, investigators, and Sponsor sponsor personnel (other than site monitors, lead clinical site managerClinical Operations Lead, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial.

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor.‌‌‌ Sponsor. This study is double-masked with subjects randomized to use both DD T2 and the assigned control product (in a randomized sequence) BIOFINITY or BIOFINITY ENERGYS for the duration of the 7 ± 2 day treatment period. The Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study with the exception of the Clinical Project Lead, who may also remain unmasked throughout the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial. Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 01-Mar-2018 Document: TDOC-0054838 Status: Effective Version: 2.0; Most-Recent; Effective; CURRENT It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the eCRF are consistent with the original source data. Only designated individuals may complete the eCRFs. The eCRFs will be submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The Principal Investigator is responsible for reviewing and certifying that the eCRFs are accurate and complete. The only subject identifiers recorded on the eCRFs will be subject number, and subject demographic information.

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor.‌‌‌ Sponsor. This study is doublesubject-masked with subjects randomized to use both DD T2 LID017569 or Biofinity for 30 days and then crossover and use the assigned control other study product (in a randomized sequence) for the duration of the treatment period30 days. The Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, CDMA PL, Alcon Observer, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial.