Cooperative Research & Development Agreements (CRADAS)

HOW AND WHEN TO USE C AADAs

http://intramural.nimh.nih.gov/techtran/cradal.htm

The Model PHS
CRADA

1. Appendix A: The Research Plan
2. Appendix B: Financial and Staffing Contributions, and
3. Appendix C: Modification to Agreement Provisions.

Other
investigator
Information
Signing Off:
Getting CRADA
Approval
CRADA
Signatures

Additional appendices addressing reporting requirements or issues specific
to the research project may also be included. Click here!for detailed
descriptions ofeachAppendi.
NIMH Principal Investigators (PIs) pursuing CRADAs are required by law
to fill out and attach a Conflict ofInterest and Fair Access Survey form.
The purpose of this form is to assure that any PI collaborating with a
company in a CRADA situation does not have a financial interest in the
company,thus raising a conflict of interest. The NIMH Technology
Transfer Office is available to help scientists draft an acceptable CRADA
and related Appendices and to proffer advice in the development of the
overall agreement. The Office will also negotiate the CRADA and
Appendices in conjunction with the appropriate company representative.
In addition to the originating scientist, the negotiated CRADA must be
approved by his or her Laboratory or Branch Chief, the NIMH Technology
Advisory Committee (TAC), and the Scientific Director for the Intramural
Research Program (IRP), NIMH. It is then reviewed by both the NIH OTT
and Office of General (OGC) before being forwarded to the NIH CRADA
Subcommittee. After addressing any changes recommended by the
CRADA Subcommittee, it is then returned to the OTT and OGC as a
prelude to final approval recommendation to the Deputy Director for
Intramural Research, NIH. Each of these parties must sign off on an
internal CRADA Clearance Form.
Bylaw, 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.
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, they may also be extended 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.
In order to expedite the commencement of the Research Plan, prior to final
execution ofthe CRADA, the NIMH Technology Transfer Office has the
authority to sign an interim Letter of Intent with a CRADA partner.

CRADA Term
Length

"Jump-starting"
A CRADA:
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Posted March 17,1997

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3/24/98 2:49 AM