Contracting

Contracting for trials within the VA/NPC (non-profit corporation) has its unique characteristics. All legally binding contracts must be signed by the Medical Center Director. Those would include both CDAs (Confidentiality Disclosure Agreements) and CRADAs (Cooperative Research and Development Agreements (the VA’s standard language for clinical trial agreements)). When there are financial aspects involved, as with CRADAs, the Executive Director of the NPC, in this case the Biomedical Research Foundation (BRF), is also a required signatory. In each case, CDAs and CRADAs, the PI, though not actual party to the agreement, must also sign the document to acknowledge the binding terms between the institutions.

The VA has dedicated attorneys (STAR-Specialty Team Advising Research) for evaluating all research related contractual documents. Having a dedicate group of attorneys for research contracting has vastly improved CRADA turnaround times.

If there are unusual IP issues, the CRADA is forwarded to the office of Technology Transfer Program (TTP) for their input. The recently updated Phase I-IV CRADA model has IP language that is considerably more sponsor friendly, another revision to speed the contractual process.