Gerry,

You've hit on a very important loophole in ICH GCP (for non-health records
managers, ICH GCP is an international standard followed in Europe, the USA,
Japan and most other developed regions for the conduct of clinical research,
see http://www.emea.eu.int/Inspections/GCPgeneral.html ).

The retention requirements for clinical trial records have always been
rather vague and it was hoped that with the implementation of the GCP and
Clinical Trial Directives, the numerous ambiguities would be resolved. In
fact, the GCP Records Managers Association made direct representation to the
European Commission regarding a range of important records management
issues. Unfortunately, these fell on deaf ears and we have two EU Directives
contracting each other and no clear guidance on retention periods. In fact
industry is still waiting for supporting guidance to the Directive to be
issued by the Commission following the withdrawal of a very poor draft
document (guidance documents have been issued for all other topics mandated
by the Directive). I have requested an explanation from the Commissioner
concerned... no response!

Back to your specific query however! I think the issue will come back to
what is in the clinical trial contract that was signed between the sponsor
and investigating institution. It is most likely that in agreeing to conduct
the trial, you agreed to comply with ICH GCP. This implies you agreed to the
investigator's responsibilities for records retention outlined in ICH GCP
i.e.  

"4.9.5 Essential documents should be retained until at least 2 years after
the last approval of a marketing application in an ICH region and until
there are no pending or contemplated marketing applications in an ICH region
or at least 2 years have elapsed since the formal discontinuation of
clinical development of the investigational product. These documents should
be retained for a longer period however if required by the applicable
regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to
when these documents no longer need to be retained."

However, when you signed the contract (over 25 years ago?), you signed up to
one of the earier versions of GCP presumably, which most likley had a
retention period of 15 years. This is one argument you could follow. Should
you now be bound by more stringent controls that you had no knowledge about
when you agreed the contract?

When I worked in industry, we often had investigators contacting us, as
sponsors, requesting that they be allowed to destroy trial records. It was
unusual for permission to be denied for records over 25 years old. Far be it
for me to promote this practice but several institutions claimed they would
destroy the records regardless of the sponsor's wishes. In reality, the
sponsor has much to lose by their destruction and would invariably pay for
their storage in suitable commercial archives. It is unlikely that a large
sponsor would initiate litigation to force record retention.... its just not
in their interest. A compromise position would be to recommend secure
off-site storage paid for by the sponsor. My last calculations estimated an
average cost of around £100 per trial centre for 15 years retention.... a
paltry sum for most pharma companies!

Hope this help.

Regards,
Eldin Rammell.
 
 
Rammell Consulting
Organisational Effectiveness through
Records & Information Management
 
Mobile: 07940 859721
Tel: 01304 381691
Fax: 0871 6610507
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-----Original Message-----
From: The UK Records Management mailing list
[mailto:[log in to unmask]] On Behalf Of Gerry Dane
Sent: 23 June 2004 14:30
To: [log in to unmask]
Subject: ICHGCP and Research Study Records

Dear All,

Any pharmaceutical bods able to assist here?

-------------------------------------------------

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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