Pending development of model CRADAs
and master CRADAs with major pharmaceutical companies, the ORD
Technology Transfer Program (TTP) is offering the interim measure
detailed in the email below from TTP Director Amy Centanni.
This allows use of clinical trial agreements (CTAs) on a
case-by-case basis.
To facilitate approval, attach
to the email to Ms. Centanni a copy of the CTA proposed for the
study. To aid NPCs, NAVREF has reinstated its
Legal
Resources link:
Link to
the NAVREF model CTA and
relevant guidance.
From:
Centanni, Amy
Sent: Friday, July 28,
2006 10:51 AM
To: VHA CO 12 ACOS
Cc: Kupersmith, Joel;
Francis, Joe
Subject: CRADA interim
resolution
We are aware that the field continues
to experience difficulties in processing Clinical Trial (CT) CRADAs in
phase III and IV clinical studies. If you have this type of CRADA in
process, and the agreement needs to be completed quickly, ORD and TTP will
consider using an interim process with a short turn around time frame to
expedite the clinical trial.
In these cases, please contact me via
email, and we can discuss a resolution consistent with VA policy.
Please use the phrase “CRADA Interim Solution: [Insert Project Name]” as
a heading so that I may easily identify the e-mail and respond
expeditiously.
For
those CRADA agreements that are proceeding through the newly implemented
CRADA process without complications, please continue to follow the
standard procedures.
Thank
you.
Amy Centanni
Director, Technology Transfer (12TT)
Department of Veterans Affairs
810 Vermont Ave, NW
Washington, DC 20420
(202) 254-0199
(202) 254-0460 (fax)
