Contracts and CDAs

Confidentiality Disclosure Agreements:

Executed CDA’s are a normal part of the initial contracting process. The CDAs bind one or both parties to keep all information regarding pre-study data confidential prior to the execution of the CRADA (see below). Since there is no financial aspects to the CDA’s, only the PI and the VA medical center director need to sign off on these agreements. The VA has CDA models they prefer to use, however corporate CDAs are acceptable, though they need to be reviewed by the VA STAR attorney team prior to execution.

Cooperative Research And Development Agreements

On December 26, 2007, then Under Secretary for Health Michael Kussman, MD, signed the VHA Directive 2007-044 Mandating Use of Cooperative Research and Development Agreements (CRADAs), described at 15 USC §3710a. CRADAs must be used to establish terms and conditions for industry sponsored research studies. CRADAs are a highly flexible form of federal contracting. They offer sponsors protections for their pre-existing inventions and a means to establish in advance ownership and treatment of any inventions that may result from the collaboration.

Each CRADA is a three-way contract signed by the industry sponsor, the medical center director at the given VA healthcare facility and its associated Non-profit Foundation. Because each CRADA legally binds the VA to specifics within the CRADA, each CRADA must undergo review and approval by VA STAR attorneys prior to CRADA execution. Model CRADAs have been developed as negotiating starting points for the various given research scenarios, Basic Science, Data Collection, Device Trials, Phase I-IV clinical trials and Principal Investigator Initiated trials.