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CLINICAL TRIAL AGREEMENT TEMPLATE - updated 9-27-06.doc
SAMPLE
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement (“Agreement”) dated as of the ____ day of_______, 200__ is by
and between ________(“Sponsor”) and _______________________(“Institution”) to conduct a
medical research study (the "Study") entitled "title "_________________________________"
(the "Protocol"), protocol number ___________________________and all subsequent Protocol
amendments. Institution agrees that the principal investigator for the Study will be
____________________________.
In consideration of the premises and mutual promises and undertakings herein contained, the
parties hereto agree as follows:
1.
DEFINITIONS
1.1
"Drug" means ______________________________________________.
1.2
“FDA” means the U. S. Food and Drug Administration.
1.3
“Protocol” means the Protocol entitled "___________________________"
attached hereto as Exhibit A.
2.
TERM AND TERMINATION
2.1
This Agreement shall be effective as of___________________________.
2.2
This Agreement shall remain in effect until all work under this Agreement has
been completed, unless it is terminated earlier in accordance with the terms of this
Agreement.
2.3
Either party may terminate this Agreement for any reason upon sixty (60) days
prior written notice to the other. Sponsor may terminate the Agreement
immediately if:
1.
Within sixty days after Institution’s receipt of Drug supplies, Institution
has not enrolled the first qualified patient/subject (as defined in Exhibit B)
in the Study;
2.
Any of the conditions for termination set forth at section 7.4 apply; or
3.
FDA halts the Study or requests that the Study be suspended.
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CLINICAL TRIAL AGREEMENT TEMPLATE - updated 9-27-06.doc
Immediately upon receiving a notice of termination from Sponsor or upon issuing
a notice of termination, Institution shall cease all Study activities as soon as
possible in accordance with good medical practice. In