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ACOS Letter to a Clinical
Study Sponsor
Some sponsors require assurance that VA
will allow a foundation-funded study to be conducted using VA facilities
and involving VA patients. The following letter has been reviewed by VA
and is acceptable for use when necessary. It may be signed by the ACOS
R&D (or by the medical center director with appropriate
modifications). This letter is not part of the clinical study agreement.
It is a separate document from VA to the sponsor and may be sent on VA
letterhead.
Sample Letter
(On VA Letterhead)
(Date)
(Sponsor Contact Person)
(Sponsor)
(Address)
(City, State Zip Code)
SUBJ: (Protocol Number - or other
reference information) ____________
Dear (Name of Contact):
The research that (Name of Principal
Investigator) has proposed to perform at the (Name of Facility) VA
Medical Center entitled (Title of Study), was approved by our Research
and Development (R&D) Committee on (Date). The R&D Committee has
responsibility for approving the scientific conduct of all research done
at this medical center. The study will be performed as part of
(Principal Investigator's) official VA duties, for which he/she may not
receive any additional compensation beyond his/her VA salary. The duties and authority of the Principal
Investigator shall include those inherent to the conduct of the study,
confidentiality terms, provision of reasonable access to study site(s)
for review of procedures and data, and assuring compliance herewith by
all subinvestigators pursuant, in each case, to the terms of the
agreement signed between (Sponsor) and (Name of Nonprofit Research
Corporation).
(Principal investigator) has designated
that funds be sent to the (Nonprofit Research Corporation) to be
administered. The foundation is a 501 (c)(3) non-profit corporation
which supports research and related education at this medical center.
The contact person for the (Nonprofit Research Corporation) is (Name of Contact),
Executive Director. The address, telephone, fax, and federal ID numbers
are:
__________________________________
(Name of Nonprofit Research Corporation)
________________________________________
(Address)
________________________________________
(City, State & Zip Code)
________________________________________
Telephone
________________________________________
Fax
Federal ID#:
_____________________________
We appreciate (Sponsor) sponsoring this
research and hope that all necessary information has been provided in
this letter. If you have any questions or need additional information,
please call me at (Telephone Number).
Sincerely,
(Name of ACOS for Research and
Development)
ssociate Chief of Staff for Research and Development
Last updated 7/2/97
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