| | OTT Cooperative and Development Research Agreements (CRADA)
Review and Approval Process
CRADA Signatures
By law, a 30-day
period exists in which to disapprove or modify a CRADA after
its finalization by NIMH. When no changes are required, the
CRADA is signed and returned to the NIMH Technology Transfer
Office to obtain the proper signatures required for execution,
namely signatures by the NIMH Director and by the collaborator.
The date of the last signature may be specified as the execution
date for the CRADA.
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CRADA Term Length
CRADA agreements
have no mandatory term length, but are often designated for
a one- to four-year term. If there is no substantial change
in the Research Plan and a CRADA has been in existence for
less than 4 years, it can be extended for a minimal period
of time by the parties' mutual agreement. Because scientific
objectives and circumstances change over time, however, any
substantial changes to the Research Plan must be reviewed
by the NIH CRADA Subcommittee or its chairman, as appropriate.
Accordingly, while a fully signed CRADA may be amended as
research progresses, all amendments must be made through the
NIMH Technology Transfer Office. Informal amendments made
between the investigators cannot be assumed to be valid.
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"Jump-starting" A CRADA: Letters of Intent
In order to expedite the commencement of the Research Plan, prior to final execution of the CRADA, the NIMH Technology Transfer Office can assist you in executing an interim Letter
of Intent (LOI) with a CRADA partner.
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