Dear All,
Any pharmaceutical bods able to assist here?
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As usual we're trying to find the quickest route to the confidential bin
for large amounts of records - in this case research records. One
sub-plot that has emerged is the relationship between ICHGCP, the
research sponsor and the investigating institution.
Question: Does the following example reflect a possible reality as a
consequence of observing ICHGCP?
1. A pharmaceutical company provides funding for a University research
study in relation to the development of a drug.
2. The study finished 25 years ago.
3. The University has asked the sponsor twice if the institution can now
destroy the records - the answer is No.
4. Reason given is that the drug has been discovered to possess other
properties for which the University study is still relevant. In short
the drug is still under development
5. When it comes to the management of documentation, the company
subscribes to ICHGCP guidance.
6. Section 4.9.5 and 5.5.12 of the ICHGCP guidance places a clear
obligation on the sponsor to inform the institution when the essential
documentation is no longer required. (It provides no leeway to the
institution in respect of destruction decisions)
On this understanding of ICHGCP the records could conceivably (provided
the drug is still under development), be kept for a very, very long time
and with no retention period or trigger event to propel them into the
bin. (ie the decision to destroy would always rest with the sponsor and
be contingent upon the drug no longer being under development)
Any opinion welcome.
Gerry.
Mr.G.Dane
University of Newcastle
Newcastle upon Tyne
NE1 7RU
Email: [log in to unmask]
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