Data Retention/Storage
How long do I have to keep study-related records after the study is completed?
*UPDATED August 2022
Regulated Drug and Natural Health Product Studies
Drug or natural health products studies that are regulated by Health Canada require 15-year study-related record retention.
Regulated Medical Device Studies
Sunnybrook strongly recommends a 15 year retention period for clinical trials regulated under a Medical Device ITA unless otherwise advised in writing by the named sponsor of the ITA. For more information, please see our
Note To File_N2SOP 024.
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Other Non-Regulated Studies
There are no defined regulations or standards for other research studies (i.e., non-regulated). The Sunnybrook research ethics board's recommended standard is ten years for non-regulated studies. However, sponsor, publishing journal or professional affiliation standards for record retention may apply.
