Hi Rikki,
Several questions come to my mind:
1.  Are the drug trial records a result of a research project at Emory
University?
2.  If yes, do these records support the final project submission for
approval?  If yes, then they probably need to be retained the same as the
research project submission for approval; and possibly as long as the drug
is on the market.
3.  If these records are in your custody for another entity then you need
to consider what other regulations may apply to drug research records - not
just the trials.  If they are for research/reference purposes you probably
need the drug trial records as well as the approvals and all other records
that provide the full story of the product.

In many cases, a research project is considered a record category, and all
pertinent and relevant documents should be retained as a cohesive group.
So you may need to consider, "How long do we need to retain the information
on this research project?  Is the product still on the market?  How long is
the potential liability for the drug? " etc.

I'm not saying that every extraneous piece of information is required, but
very careful that keep the whole story.  This applies to most research
projects but I think drug research records carry a high level of risk so be
careful before you shred.

Mary
Mary W. Haider, MBA, CRM
Records & Information Manager and Consultant
[log in to unmask]
865-983-1371



On Mon, May 7, 2012 at 9:49 AM, Chesley, Rikki <[log in to unmask]>wrote:

> Hello list.
>
> I wonder if anyone out there is willing to help me?
>
> I have the FDA rules on drug trials, and I know this is going to shock and
> amaze you all, but  one of my researchers doesn't feel that this is quite
> long enough and is certain that there is an international standard out
> there that trumps and exceeds the FDA standards on the retention of drug
> trail information.  I have not found it.  I will be honest I only gave a
> modest effort knowing I could come to you and some of you must work in
> Pharma and know the regs inside and out.
>
> So, my question,  is there some ISO standard or standards governing
> retention of drug trial data and if so, will you please point me to it?
>
> Thanks and have a smashing Monday morning.
>
>
> Rikki Chesley, CRM
> University Records Manager
> Manuscript, Archives, and Rare Book Library
> Emory University
> Robert W. Woodruff Library
> 540 Asbury Circle
> Atlanta, Georgia 30322
> 404-727-8816
> [log in to unmask]
>
>
>
>
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