Hi, Lakshmi.
I'm assuming that the other researcher is at the same institution, so no shipping documents will be generated as part of this transfer. I'm also assuming you are asking this question on behalf of the CRO or the PI, not the study sponsor.
The best regulatory advice is probably to ship the drug back to the Sponsor and let the Sponsor do whatever it wants to do with it once it has it in hand, including donating to another researcher. If that is not an option for some reason...
Once your PI has accounted for all drug received by the site, they should have a complete inventory of the drug that was not used during the study, and which now must be disposed of somehow. I would write a formal letter from your PI to the other researcher, stating that Sponsor Y provided your PI with X units of Drug A to use in the conduct of Study Z under IND# ______, that your PI has completed this study and now has Y units of unused study drug on hand for disposition. I would have your PI state that Sponsor Y has directed your PI to dispose of these X unused units by transferring them directly to the other researcher. I would include a complete inventory of the units to be transferred, with lot/batch numbers, etc, in the body of the letter if practical, or as an attachment if not. I would copy the Sponsor on this letter.
Since will be no third-party shipping documentation available, I would also follow up with the other researcher to get documentation of what they received, which should be an exact match with your inventory of unused study drug that your PI "shipped" to them. If both researchers are at the same institution, this could potentially be accomplished in a face-to-face hand-off, in which the other researcher wasn't permitted to walk away with the unused drug until the they provided your PI with signed documentation of what it was that they were walking away with.
I would also want a letter from the Sponsor on file to support the PI's claim that this disposition method was "per the Sponsor's instructions."
Finally, I would probably consider fielding this question to the ACRP forum too...
------------------------------
Julie Omohundro, ex-RAC (US, EU), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 18-May-2016 13:03
From: Lakshmi Venkatakrishnaiah
Subject: drug accountability-IND study
This question involves a study conducted under an IND with a marketed drug at a US site.
At the end of the study, the site requests the sponsor to donate the drug
for use by another researcher at the site, for use in a different study.
I realize there are many reasons to refuse this request, however, if the sponsor
wants to do go ahead with the donation, what is the best regulatory advise
and what documentation is needed?