NOTICE- Study Archives:
There has been some confusion regarding file storage for research studies. Health Canada, Food and Drug Regulations require that a study sponsor maintain all study records in archive for a period of 25 years. The responsibility for both the cost and space for storage of records is with the sponsor. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/reg/1024-eng.php
It is recommended that all study budgets include a line item for approximately $2,500.00 (relative to study and subject to change) for off-site archiving at a secure facility for 25 years (i.e. Iron Mountain)
Storage for study documents are not currently available at Covenant Health facilities.
NOTICE: Study Information Sheets
All Patient Information Sheets should list contact information as follows:
*Covenant Health - Patient Relations Office: 780.735.7494 |