Charlie Sodano wrote:
>>As Nancy Freeman mentioned,  pre-clinical research data can be shelved
>>and
then revived many years later.

The FDA only has a 2 year retention for pre-clinical records, after submission.  Deciding how long to keep research records is a business decision, not a regulatory requirement.  Is this also your understanding?

We are a little off topic from the original question but pre-clinical  research records is definitely a hot button. My question comes to the fact that most research organizations are 3rd party. They aren't going to know anything about when or if marketing permits are applied for or issued. They also will have no knowledge of batch expirations. I agree that it does become a business decision. It also gets to the discussion of joining the "keep everything forever" club. Does that include keeping records and information that are both electronic and paper from proprietary instruments and applications that have the lifespan of a fruit fly?

We can say it but doing it is another matter. If you say you have it, you have to find and produce it- now and forever. For raw project data 20-50 years down the road that's going to be tough sell and it's going to be a tougher sell to spend resources on keeping that data when the contract is closed and the revenue stream is long gone. It also gets interesting when organizations have bought and sold products and development rights. Which organization has rights to access to the research 20 years down the road?

At what point does that previous data become obsolete either by the passage of time, standards, media, hardware, applications, and even organizational memory? Even if you have it you are going to need to reproduce the study because someone is bound to say the old data is "extremely primitive" with "questionable results" and "archaic standards". Forty years is a long time to maintain records just to hear that snippy comment especially when you have heard it said about research records that are only FIVE years old!

Rob Seibolt, CRM
Supervisor-Records Management
816-360-5480
http://www.mriglobal.org


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