The new Model Clinical Trial CRADA for Phase III and IV studies is accessible on the VA intranet at http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

This new model is the result of a great deal of effort by the aptly named CRADA Work Group which is comprised of TTP, OGC and NAVREF representatives. Outside of the WG itself, a large number of OGC attorneys and ORD personnel have been valuable resources throughout development of the new model. In recent weeks, additional VA attorneys, FRAC members and NPC personnel from around the country have helped greatly by reviewing successive versions of the model and providing valuable input from the field perspective.

NAVREF thanks to all for their contributions to this significant achievement.

The new CT CRADA is being sent today to NAVREF’s NPC contacts, the ACOS/R at VA facilities and to VA attorneys. TTP and OGC will present it to pharmaceutical companies next week during the International Contracting and Negotiating Clinical Trials Conference. Nancy Watterson-Diorio, executive director of the Boston VA Research Institute, will also attend to respond to questions about NPCs and their role in CRADAs.

Anyone negotiating Phase III or IV CRADAs may use the new model and is encouraged to do so. However, TTP is giving everyone time to become familiar with it so the current flexibility on use of CRADAs, and the TTP waiver process for clinical trial agreements, will remain in place until further notice. For the present, please review the new model and get acquainted with it. For your convenience, click here for an index of articles and subsections in the CRADA.

The CRADA Work Group is exploring holding a conference call or some other form of interactive communication to update NPC personnel and VA attorneys on the continuing transition to CRADAs and to answer questions about the new model. Please watch for an announcement about the format, date and time. In the meantime, questions may be directed to Amy.Centanni@va.gov or Jeffrey.Moore@va.gov in TTP.