The matter at issue is the ability to use scanned pt records, on
disk, in place of paper and still be able to remain in compliance
with the FDA, NIH et al.

I would greatly appreciate any insight or exposure to this issue that
you could provide. Thanks

Barbara -

All of the items you mentioned along with any other document
associated with the patient record. The entire case book would be
scanned at the conclusion of the study after final review by the
company monitors. The items would be sent to the company that
currently scans our medical records. When they return our material on
a read only CD, we verify through random sample that the material is
contained on the CD. The original records are then put in the
confidential bin for shredding. What you see is what you get with no
opportunity once scanned to modify the record. Of course a paper file
could always be modified, so I'd say that this process is holier than
the current paper process. The printed copy of any page from the CD
looks identical to any printed copy you would make from the original.
If the FDA found a problem with the research outcome they would ask
the company and /or each site to given them what?  The original case
reports allowing each site to retain only a copy while FDA does it
thing or would they ask for copy of all material? If it the later,
what's the issue? If it the former how does the scanned version fail
the smell test for the FDA.

Currently for non-research patient records, the first view of the CD
will have a legal statement noting our standard operating procedure
to scan record in its entirety as digitalized image and indexed for
locating the records.  The statement has yet to be prepared or
reviewed by Fred. I think one statement should be created that covers
any document we scan.

We would really like to push this through as fast as possible for the
company to then confirm it works on their end. I don't know if that
means they will go to FDA or have their legal counsel bless it. We
are rushing to get this all before the next IRB meeting.

Thanks for your help.

>Dear Laura,
>
>What specific records are on the plate? One of the issues that needs
>to be considered is someone raising a scientific misconduct charge
>such as altering records. I assume that you are taking about patient
>case report forms, informed consent forms, written Institutional
>Review Board approval for the conduct of the trial, and records
>regarding the receipt and disposition of the study medication.
>
>What about lab books?
>
>Barbara

Barbara Pifel
Senior Director
Grants and Contracts
Rm: A131
Telephone: (212) 746-6020 6-6058
Fax:       (212) 746-6938

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