Negotiating A CRADA

A full CRADA requires two types of negotiations, the Research Plan and the "boilerplate." The Research Plan is a detailed description of the research to be performed. The reagents to be used, the methods to be used, the problem to be solved, and the relative contributions of the parties need to be set forth in great detail. The Principal Investigators on both sides of the CRADA work together to sculpt a proper Research Plan. The NIMH Technology Transfer Office assists them, by providing guidance with regard to the format required for NIH review of the CRADA. As appropriate, the "boilerplate" may be modified by the parties, subject to conformance to applicable law and policy. As soon as both participating scientists negotiate the Research Plan (namely, the written description of the research and development project, including each party's contribution to the planned research and development), a written CRADA should be developed. NIH has a model CRADA, available elsewhere on this web site, which is required and used as the basis for all negotiations with outside parties.

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The Model PHS CRADA

The model CRADA contains three appendices:

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

Additional appendices addressing reporting requirements or issues specific to the research project may also be included.

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Clinical Trial CRADAs

CRADAs are appropriate for both basic research projects and for projects involving clinical trials. The same PHS model CRADA agreement is used for both types of research; however, a Clinical Trial CRADA (CTC) has additional terms added to Appendix C which address such issues as INDs, protection of human subjects, adverse reactions, etc. (Click here to view the Appendix C modifications for Intramural or Extramural Clinical Trial CRADAs.)

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Other Investigator Information

NIMH Principal Investigators (PIs) pursuing CRADAs are required by law to fill out and attach a Conflict of Interest 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.

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Signing Off: Getting CRADA Approval

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. 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.

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