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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.

    For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

    Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

    All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.

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.

    For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

    Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

    All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.

Principal 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.

    For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

    Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

    All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.


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.

    For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

    Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

    All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.

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

For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.


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 VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.


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.

    For VA Employees only. All CRADA model agreements (except master CRADAs) can be retrieved from the VA intranet link below.

    Copy and paste this URL into your browser: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

    All other institutions should contact Noahline Stuart (noahline.stuart@va.gov) for a copy of the current models listed below.

Other Agreements


Model Confidential Disclosure Agreement

TTP, together with OGC, has prepared three model Nondisclosure agreements, for use when VA is sending confidential information, when VA is receiving Confidential information, and when there is a mutual exchange of Confidential information. While these documents are undergoing final review, they are available for use. The titles of the documents are self-explanatory. The bolded language needs to completed at the site. The authority to execute the document is the VAMC Director or whoever he/she designates per VA Directive.

Basic Material Transfer Agreement (MTA)

The Basic Material Transfer Agreement (MTA) (42 KB, Word) can be used when VA is the recipient or provider of material and no intellectual property rights are transferred. If VA is the recipient of a material and the provider would like an IP commitment please use the MT CRADA. If VA is the provider of a material please use this MTA. MTA's that do not contain IP provisions (whether or not based on VA's model agreement) may be approved locally and signed by the ACOS for Research. When in doubt, please contact the TTP office.


Forms


NOTE: CTAA TEMPLATES ARE BEING REVISED