Yesterday, the CRADA Work Group completed a few revisions to the model Phase III and IV Clinical Trial CRADA and released for use a new model Phase I and II Clinical Trial CRADA.

Both new CRADAs are available on the VA intranet at http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

The changes in the model Phase III and IV CT CRADA were made in response to suggestions from the field and from sponsors during the recent MAGI Conference on Contracting and Negotiating Clinical Trials during which TTP and OGC presented on VA CRADAs. Changes have been made in Articles 8.2.2, 8.3.1, 8.3.2, 12.1.2, and 13.3. Also, the order of signatures has been changed on the signature page.

The most significant changes are in Article 8, which now more closely reflects the CRADA statute. OGC attorney Renée Szybala explains, “We have done this to provide the most protection available to Collaborator information under FOIA. Courts have been solicitous in finding CRADA info exempt from FOIA under these provisions . . .” This and other CRADA terms will be explained in an annotated version of the model CT CRADA that is currently under development.

The new model Phase I and II CT CRADA is identical to the Phase III and IV model with one important exception: the Phase I and II CT CRADA does not provide the non-exclusive royalty-free license in Article 6.1. However, it does give the collaborator the option to choose its preferred type of license and to negotiate appropriate terms.

Model CRADAs may continue to evolve on the basis of experience and comments from NPCs, VA attorneys and collaborators so before offering a model CRADA to a potential collaborator, please pull the latest version from the VA intranet. Each version is dated in the footer. Also, be sure to offer the CRADA appropriate for the situation. Each model is clearly marked on the cover page.

The WG is working on additional models and new SOPs for processing CRADAs that should be available shortly. And VA attorney Jim Klein, who has been detailed to work on master CRADAs, is contacting major pharmaceutical companies to re-start stalled discussions. Please watch for future notices as the transition to CRADAs continues.