Please click here for an updated table showing progress to date on master template negotiations. The big news is that negotiations on the Astra-Zeneca master are complete and the master is undergoing the final VA concurrence process. Several other masters – Amgen, Merck, Pfizer and Sanofi-Aventis - are close to completion.

In an email, Jeff Moore stated, “The companies highlighted in green mean their CRADAs can be used on a single site basis today.” To obtain one of these for a single-study/site CRADA, send an email to Jeffrey.Moore@va.gov.

Jeff asks, “If any NPCs have contacts with companies not on the list, and they think a master template CRADA would be good to have with that company, please tell them to forward the contact info to me. Or better yet they can make introductions between me and their contact.

” OGC has completed its concurrence review of the updated Phase III&IV Clinical Trial CRADA. This has just been posted on the VA web site (http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm), and should be used in lieu of the model published in June 2007. An updated Phase I&II CT CRADA will follow shortly. A number of user-friendly improvements have been made in these models, many of which originated with suggestions from sponsor attendees at the conference on CRADAs in February.

This week the CRADA Work Group is performing a final review of the model PI-Initiated Clinical Study CRADA and the model VA Data Collection Agreement. The final step in the approval process will be OGC concurrence which is expected to be complete before the end of the summer.

Please note: In the coming weeks, in addition to being posted on the VA intranet (http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm), model CRADAs will be available on VA’s publicly available tech transfer web site. See: http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm This will make the models more accessible to NPCs and sponsors. SOPs and annotations for each model will remain only on the VA intranet at http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm.