VA CRADAs

For those without access to the VA Intranet, request copies of the current documents from the TTP staff assistant, Ms. Noahline Stuart (Noahline.Stuart@va.gov).

Model CRADAs, annotations and SOPs will be updated from time to time so it is important to download the current version of the appropriate model each time CRADA negotiations are initiated.  Models are linked below only for identification purposes and may not be the most current versions.

NPCs that do not currently have access to the VA intranet are encouraged to pursue one of the following:

1. Obtain VA intranet access for at least one designated NPC staff member. This involves obtaining a VA email address and undergoing VA training. Consult the local Information Security Officer (ISO) or IT Office for assistance.

2. Work with the facility Research Office to designate a VA staff member who will download these documents for you as needed.

If neither of these is possible, request copies of the current documents from TTP staff assistant, Ms. Noahline Stuart (Noahline.Stuart@va.gov).

NAVREF encourages NPCs to arrange their own direct access to the VA intranet. New master template CRADAs, new models CRADAs as well as updated versions of existing models and guidance will be posted from time to time so convenient access to the VA intranet is recommended.

 

2.  VHA CRADA Implementing Directive and FAQs

On December 26, 2007, Under Secretary for Health Michael Kussman, MD, signed the VHA directive mandating use of CRADAs.  As described in the FAQs, use of CRADAs will be mandatory as of March 26, 2008, ninety days after signing of the directive.  Please take a few minutes to become familiar with the FAQs and the directive.

VHA Directive 2007-044 Mandating Use of CRADAs
CRADA FAQs

For comprehensive information about VA CRADAs and CRADAs in general, please go to the VA R&D web site regarding technology transfer:  http://www.research.va.gov/programs/tech_transfer/crada/default.cfm

Use the links at the left of the web page to navigate the site.

 

4. Timely Communications

On December 13, 2011, TTP and OGC conducted a national conference call for NPCs to clarify policy regarding "re-use" of an approved CRADA. 

Click below for a link to the audio recording of the call and the applicable SOP - Re-Use of Previously Negotiated CRADAs.

• Audio recording

• SOP

• Sample Memo requesting Regional Counsel review of a CRADA 

• Sample Memo requesting Medical Center Director signature on an approved CRADA 

• CT CRADA compliance with AAHRPP requirements regarding sponsored clinical studies agreements
   

• CRADA Statute - 15 U.S.C. §3710a
• CRADA Statute re: Royalties - 15 U.S.C. §3710c