VA CRADAs
Publication of the Novartis Master Template - October 22, 2007
Email from
Dr. Kupersmith:
Letter
signed by Novartis
Decision memo signed by VA
I am pleased to
announce that the Technology Transfer Program (TTP)
and Office of General Counsel (OGC) have
successfully negotiated the first master
template CRADA with Novartis Pharmaceuticals.
The Acting General Counsel has concurred and the
Under Secretary of Health has approved for
nationwide implementation in Phase II/III, III,
or IV Novartis clinical trials (see attached).
In addition, attached is a
letter from Novartis’ Chief Scientific Officer,
U.S. Clinical Development that states the
approval for use by Novartis. The approved
Master CRADA Template will greatly simplify and
reduce the negotiating time for clinical trials
with Novartis.
If you use this
Master CRADA template, I encourage you to read
it thoroughly and familiarize yourself with the
agreed upon terms. Since this CRADA is a highly
negotiated document and the terms are considered
confidential it will not be posted on the
website. As soon as you are contacted to
participate in a Novartis study please e-mail
Noahline Stuart (Noahline.Stuart@va.gov)
to request a copy of the VA/Novartis master
template CRADA.
In addition,
please note that the language negotiated in the
master template CRADA is specific to this CRADA.
No parts of this master template CRADA should be
integrated into single CRADAs that are
negotiated locally, unless approved by Central
Office.
Key
points
·
The Novartis Master CRADA should be used only
when all of the following criteria have been
met: 1) the clinical trial is a phase II/III,
III, or IV clinical trial;
2) Novartis writes the protocol and 3) Novartis holds the
investigational new drug (IND) application
·
No part of the CRADA template may be
renegotiated at the local level; thus the
agreement will not have to come to
central office for review and approval. It
can be approved locally by the regional counsel
attorneys and will be signed by the local
Medical Center Director.
·
Local VA medical centers and non-profit
corporations will need to negotiate the
budget and statement of work (in most
cases the protocol).
·
Proper institutional review board (IRB) and R&D
committee approval must be obtained.
·
Patient Authorization and Informed Consent forms
must be agreed to prior to execution of the
CRADA.
·
Access of monitors: The master template CRADA provides that access to VA source
documents required for monitoring of the
clinical trials shall be provided by VA and that
such monitoring shall be conducted in accordance
with VA policies and procedures. Access of
monitors remains up to the local level to
negotiate. The research office or NPC must
provide VA access requirements (determined by
their local ISO) to Novartis before signing the
CRADA to ensure that the needs of both parties
are met. If you have difficulties in
determining how access will be provided, please
let us know. We can help. If you
cannot reach agreement in monitor access, the
CRADA should not be signed.
·
Genomic Research: If the protocol involves genomic medicine or human biological
specimen banking, there may be a need to contact
Dr. Marilyn Mason (Marilyn.Mason@va.gov).
Human biological specimens collected under a VA
approved protocol are not considered to
be "banked" specimens if they are used for only
the specific purposes defined in the protocol
and are destroyed either when the specific
testing/use is completed or at the end of the
protocol. Dr. Mason does not need to be
contacted under this circumstance. However,
biological specimens collected and stored for
future research purposes that are beyond the
scope of work described in the original protocol
and informed consent or those collected
under a protocol designed for banking of
specimens are considered banked biological
specimens. In these cases please contact
Dr. Mason to fill out the proper VA request
forms. Additional information on banking
can be found on the VA Office and Research and
Development website under programs and VA Tissue
banking program.
·
CRADA Registry:
All executed CRADAs with Novartis should be
entered into the CRADA registry and sent to
Noahline Stuart (Noahline.Stuart@va.gov).
The CRADA registry can be located on the Office
and Research and Development website, Technology
Transfer Program, CRADA link. A copy of
the executed CRADA, either hard copy or
electronically, should be sent to Noahline
Stuart for record keeping.
If you have any
questions about the master CRADA template with
Novartis please contact Jeff Moore (Jeffrey.Moore@va.gov)
at 202-701-7628.
Thank you,
Joel Kupersmith,
MD
Chief Research
and Development Officer
