Subject Confidentiality. 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 Study Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Study Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information will be transmitted to the Study Sponsor. The Study Sponsor may release anonymized study data to external researchers for purposes of future research directly related to the study objectives, or future research that is beyond the scope of the current study objectives. The Informed Consent Form explains this to study subjects. Anonymization means that all identifiable information will be removed from the dataset and all links to the subjects in the study will be removed. Anonymization of the data will maintain confidentiality of the subjects who participate in the study so that they cannot be identified by external researchers. The anonymized data set will contain records from all of the subjects in the current study, but the anonymization process might change the data set in some ways, so external researchers will be informed that they might not be able to duplicate some of the results from this study.
Subject Confidentiality. The investigator must ensure that the subject’s identity is kept confidential 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. The study sponsor may collect a copy of the enrollment log without any directly identifying subject information. The study sponsor may share patient-level data collected in this trial with qualified researchers to help facilitate product development or enhancements in research that is not directly related to the study objectives. The Informed Consent explains this to the study subject.
Subject Confidentiality. 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.
Subject Confidentiality. In order to maintain subject confidentiality, only a site number, subject number and subject initials will identify all study subjects on CRFs and other documentation submitted to the Sponsor. If specific consent is given, the subject’s CFF patient registry number will also be collected. Additional subject confidentiality issues (if applicable) are covered in the Clinical Study Agreement.
Subject Confidentiality. Subject confidentiality must be contained at all material submitted to the key sponsor contact. The following rules are to be applied. • Subjects will be identified by a unique identification number • Date of birth or year of birth/age at time of enrollment will be reported according with local laws and regulations For reporting of serious adverse events, subjects will be identified by their respective subject identification number, initials and data of birth (as per their local reporting requirements for both initials and date of birth) Per federal regulations and ICH/GCP guidelines, investigators and institutions are required to permit authorization to the sponsor, CRO, IRB/IEC and regulatory agencies to subject’s original source documents for verification of study data. The investigator is responsible for informing potential subjects that such individuals will have access to their medical records which includes personal information.
Subject Confidentiality. Subject confidentiality must be maintained for all material submitted to the key sponsor contact. The following rules are to be applied. • Subjects will be identified by a unique ID number. • Date of birth or year of birth/age at time of enrollment will be reported according with local laws and regulations. For reporting of SAEs, subjects will be identified by their respective subject ID number, initials, and date of birth or year of birth (as per their local reporting requirements for both initials and date of birth). Per federal regulations and International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) guidelines, investigators and institutions are required to permit authorization to the sponsor, Contract Research Organization (CRO), IRB/IEC, and regulatory agencies to subject’s original source documents for verification of study data. The investigator is responsible for informing potential subjects that such individuals will have access to their medical records, which includes personal information.
Subject Confidentiality. The Investigator must ensure that the subject’s anonymity is maintained. In the eCRFs or other documents submitted to the Sponsor and/or designated CRO, subjects should be identified by a subject identification number and/or randomization number. Documents that are not for submission to the Sponsor and/or designated CRO (e.g., signed informed consent forms and subject information sheets) should be kept in strict confidence by the Investigator in compliance with local regulations/ICH GCP Guidelines. It is required that the Investigator and institution permit authorized representatives of the Sponsor, of the regulatory agency, and the IRB/IEC direct access to review the subject’s original medical records for verification of study-related procedures and data. Direct access includes examining, analyzing, verifying, and reproducing any records and reports that are important to the evaluation of the study. The Investigator is obligated to inform the subject that his/her study-related records will be reviewed by the above named representatives, although the confidentiality of his/her records will be maintained as much as reasonably possible. For the purposes of the study, only the data set forth in this protocol (including the CRFs) will be obtained regarding participating subjects (whether screen failures or enrolled subjects). Such data shall: • be processed in accordance with this Protocol or as otherwise instructed by the Sponsor; • be processed solely for the purposes of the study and in the manner specified in this Protocol; • not be processed in any manner incompatible with the purposes of the study; • be accurate, up to date and corrected to address any inaccuracies or omissions; Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***]. Protocol VB-201-064 VB-201 • be maintained (as specified in this Protocol/using reasonable measures) to protect against accidental or unlawful destruction, accidental loss or damage, alteration, unauthorized disclosure or access and against other unauthorized or unlawful forms of processing; • not be disclosed to any third party without the Sponsor’s prior written consent; and • be maintained as detailed in Section 13.3 unless a longer period is required by applicable laws or regulations. Any reasonably requested assistance shall be provided to assist the Sponsor to enable it to comply with any data-related notification obligations ...
Subject Confidentiality. All patient data collected and processed for the purposes of this study will be managed by the sponsor with adequate precautions to ensure the confidentiality of those data, and in accordance with applicable national and/local laws and regulations on personal data protection. No patient identifiable data will be obtained. In any presentations of the results of this study; at meetings or in publications, the patients’ identity will remain confidential.
Subject Confidentiality. Results obtained from the analysis of data obtained in this study may be submitted for publication by the investigators. No personal identifying information will be included in publications. All study documentation will be identified by the unique study IDs assigned to participants with no personal identifiers of the participants. All records will be stored in locked cabinets. Electronic database access is password protected and any data exported and shared for analysis purposes from the database, will contain only study IDs and no personal identifiers. No data will be shared with parties not involved in the study through data collection, monitoring, analysis or sponsoring of the study. New ethical approval will be obtained for any data sharing beyond the scope of this project.
Subject Confidentiality. The investigator and members of the site staff must ensure that the subject’s confidentiality is maintained: All electronic information regarding study participants will be kept on a password protected computer. The study sites’ data management and clinical staff will be the only personnel with access to the protected health information of the study participant. All research records will be kept according to ethics committee, ICH and regulatory requirements (whichever is the longer duration) following closure of the study. Identifiable information will not be stored in the eCRF and will not leave the site. Original records pertaining to this study may be inspected / audited at any time by Opthea employees or their duly authorized representatives, a regulatory authority or the IEC / IRB. All records accessed will be strictly confidential. Consent to participate in this study includes consent to direct access to records and these inspections / audits.
