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Destruction of Study Records at a Site

By Bonnie Adorno-Perez posted 06-16-2011 11:57 AM

  
I am curious if anyone has gone thru the process of actually destroying study records at a site after notifying the Sponsor.

 per the regulations 21 CFR 312.62c

 An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

If so, what type of process was followed? Once sponsor was notified that the site would destroy the records and acknowledgement received did sponsor or investigator notify the FDA that the records would be destroyed?

Any feed back would be welcomed!
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Comments

Raja' Sammour
06-22-2011 03:40 AM

Done this before for bioequivalence research. We send sponsors that we are going to destroy study documents and when the approval comes we do. The destruction is carried out and documented without providing notices to regulatory bodies because the period that is manadated has elapsed.