Hi Judith:
Here at Merial, we do require an archive statement that is signed by the
submitter. (I can send you an example offline if you like) It contains the
contents of what is being submitted. The archivist will verify the contents,
sign the form and send a copy back to the person to let them know it arrived
safely.
If the study is GLP, then we - of course - follow CFR 21: part 58 and archive
it immediately after study director signs the final report. There are not
really any industry regulations or guidelines that say "HOW" to archive, only
that your archive have limited access and conditions of storage shall
minimize deterioration of the documents and/or specimens in accordance with
requirements for the time period of retention. (and of course, that you can
retrieve it in a timely manner)
We archive only original study information (protocol, study report, raw data,
lab notebooks, etc)
When bulk studies are sent, the majority of the volume is raw data, we
require the submitter to give page ranges and the archivist will check that.
They do not go through page by page.
Hope this helps!
-----Original Message-----
From: Records Management Program [mailto:[log in to unmask]] On Behalf
Of Johnston, Judith
Sent: Wednesday, June 25, 2008 1:27 PM
To: [log in to unmask]
Subject: [RM] Additional Information on Best Practices/ Requirements for
Submitting items to Archives
Hi Again,
Thanks to everyone for all of the quick feedback. My apologies for
several things that I have already been made aware of:
- I neglected to fill in the subject-sorry!
- I neglected to introduce myself, again, my apologies.
My name is Judi Johnston. I am a Records Manager at Solvay
Pharmaceuticals, a mid-sized global pharma firm. I have been in RM for
about 9 years.
_______
Also, I noticed that the post below was truncated. I'll paste again,
just in case:
I would like to get consensus on how regulated industry (pharma and
non-pharma) handle archival submissions. That is, is there a system in
place to handle these? Are paper and/ or e-forms used? Is there a need
felt to maintain information on who and when something was submitted for
archiving, or just note that something has been received? What
regulations and/or standards are used?
Also, if bulk submissions are received, are there expectations that
inventories will accompany them, or is it just the responsibility of the
archivist? If so, is (and/ or how) is this enforced?
________
Maybe I should be more specific...When someone submits paper documents
or media (something physical) to an archive, what are some of the
examples of the things they need to do? Fill out a form (paper or
online), give a "head's up" e-mail that something is coming to be
archived, submit a form or something through an electronic system that
spits out a barcode (thanks Melissa from Vertex Pharma!)etc.?
How is this different when there are electronic records? Perhaps they
are submitted on media or maybe through an e-mail, etc. Does the same
form or procedure apply? If not, how is it different?
Does everyone conceed that collecting information about who submitted
the document to the archive is important? I am also especially
interested in what global counterparts might be doing as well. Hope this
helps...
Kind Regards,
Judi
-----Original Message-----
From: Records Management Program [mailto:[log in to unmask]] On
Behalf Of Peter Kurilecz
Sent: Wednesday, June 25, 2008 12:59 PM
To: [log in to unmask]
Subject: Archival submissions was Re: [RM]
Hi judith
are you speaking of true archival submissions ie items that have
longterm historical value or are you using the term "archival
submission" like an IT person would ie for storage? Or are you asking
for the storage practices for inactive records.
On Wed, Jun 25, 2008 at 12:00 PM, Johnston, Judith <
[log in to unmask]> wrote:
> Dear All,
>
> I would like to get consensus on how regulated industry (pharma and
> non-pharma) handle archival submissions.
--
Peter Kurilecz CRM CA
[log in to unmask]
Richmond, Va
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