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Data collection, management, and confidentiality

OF Oli Abate Fulas
AL André Laferrière
DW D. Mark A. Ware
YS Yoram Shir
TC Terence J. Coderre
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Data will initially be collected on paper-based source documents filled out at every visit. Data will then be transferred promptly into a spreadsheet stored in a password protected drive. Data entry and management will be completed by one of the study coordinators and the sponsor will not have access to the data. All source documents and data sheets used in the clinical trial will not have patient identifying information; instead, patients will be assigned a study code number with the key securely stored to ensure confidentiality. All information pertaining to the study will be retained by the principal investigator for 25 years after completion as per guidelines of Health Canada.

Copyright and License information: The Author(s) ©2021
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