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Model Agreements
License
CRADAs
Clinical Trial Cooperative Research and Development (CT CRADA)
CT CRADA phase I or II
This agreement is only to be used for a phase I or II Clinical Trial where the sponsor (company) writes the protocol and holds the IND.
CT CRADA phase III or IV
This agreement is only to be used for a phase III or IV Clinical Trial where the sponsor writes the protocol and holds the IND.
Principle Investigator Initiated Cooperative Research and Development Agreement (PII CRADA)
The PII CRADAs shall be used when a VAMC participates in a study of an FDA approved drug or device already on the market, for which a VA investigator designs the protocol and holds any investigational new drug (IND) application. A commercial company may provide funds, materials and/or equipment. The study may involve human subjects or materials derived from humans.
Investigational Device Clinical Trial Cooperative Research and Development
The Device CRADA model shall be used for collaborative research, development, engineering, testing or evaluation studies involving devices.
Data Collection Agreement (NEW)
This agreement is only for use with projects that meet all of the following criteria:
(a) The SOW calls for the retrospective or prospective collection of data from patient medical records, such as Registries, data mining and outcomes analysis.
(b) The SOW does not call for any interaction with patients.
(c) No intellectual property is anticipated from the project and neither party is interested in pre-commitment of intellectual property rights.
(d) The sponsor is not seeking individually identifiable information as defined in this agreement. See paragraph 5.2
Basic Science Research Cooperative Research and Development
Basic Science CRADA model shall be used only for collaborative research, development, engineering, testing or evaluation studies when a VA investigator designs or contributes substantively to the design of the statement of work, and the study does not involve human subjects or materials derived from humans.
For a copy of the current model, please contact Noahline Stuart (noahline.stuart@va.gov) .
Material Transfer Cooperative Research and Development (MT CRADA)
This agreement is to be used when VA is the recipient of a material and the company would like the right to license any improvement or intellectual property (IP) that might stem from the research conducted from the transfer of the material. If IP is an issue this agreement must be used. If IP is not an issue please use the basic MTA below.
Other Agreements
Model Cooperative Technology Administration Agreement (CTAA)
The Model CTAA is intended for use as a draft and should be viewed as a starting point for beginning negotiations with VA. Partners are encouraged to mark-up this draft with requested changes and submit to Noahline Stuart (noahline.stuart@va.gov) for review and final negotiation.
Model Confidential Disclosure Agreement
This Confidential Disclosure Agreement is made as of the last dated signature, by and between the United States Department of Veterans Affairs as represented by the Technology Transfer Program, Office of Research and Development.
Basic Material Transfer Agreement (MTA)
This Basic Material Transfer Agreement (MTA) can be used when VA is the recipient or provider. Please note: with this MTA no intellectual property rights are given. If VA is the recipient of a material and the company would like an IP commitment please use the MT CRADA above. If VA is the provider of a material please use this MTA.
Forms
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