Hi Rikki,

A little late to the game here, but at UVA we do a lot of clinical trials for drugs and devices.  You need to check either in the contract or in the protocol about the retention of the records - as the sponsor will often put in language about the retention.  Most commonly used is "maintain the records until released by the sponsor." Meaning that you have to get sponsor permission before destruction.  In some contracts/protocols there may also be a requirement to inform the sponsor of where the records are located and any time they change location.

In terms of the difference between the FDA requirements and those in Canada it is dependent on whether the drug company will use the data reported during your trial as justification for approval for marketing in that country.  And if it's a drug/device to be approved in the EU I've heard the retention time could be even longer.   Also in many cases, a sponsor does not want to know or should not know the identity or the data collected from specific human participants.  Their identities need to be retained by the trial site in case you are required to contact them about their participation in the trial.

I'd be happy to discuss this issue in more detail off line - feel free to email me or call me.
Caroline

Caroline J. Walters, MA, MLS, CRM
University Records Officer
Information Security, Policy & Records Office (ISPRO)
University of Virginia
Box 400898
Charlottesville, VA 22904
(434) 243-9162
fax  (434) 243-9197
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www.virginia.edu/recordsmanagement

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