Confidentiality {27}
PID
Every effort shall be made to protect participant privacy and confidentiality to the extent permitted by law. All trial-related information shall be stored securely at the trial site.All paper-based participant information shall be stored in lockable file cabinets in areas with access limited to trial staff. Data collection, process, and administrative forms, laboratory specimens, and other reports shall be identified by a coded number only, to maintain participant confidentiality. Participant identifiers (PID) shall contain the number of the trial site and the individual participant number allocated at randomization.All records that contain names or other personal identifiers, such as locator forms, participant identification code list and informed consent forms, shall be stored separately from study records identified by code number. Only the trial health-care personnel directly responsible for the participant’s care and one designated data management member of staff shall have access to these records.All databases shall be secured with password-protected access systems.If the participant’s name appears on any other document (e.g., pathologist report), it shall be obliterated before a copy of the document is supplied to ISGlobal.Participants’ study data, as identified by PID number only, shall not be released without the participant’s written permission, except as necessary for review and monitoring by:•Authorized study representatives•Local and international RAs•IECs/ IRBs•Sponsor Monitors•Sponsor and third-party AuditorsWhen the results of the study are published, the participant’s identity shall remain confidential