Pathways to Begin a Multi-Center, Pharmaceutical-Initiated, Industry, Clinical Research Study at the VA
Contract negotiation and regulatory preparation can happen concurrently when working with the VA. The above diagram shows the steps necessary to get a trial fully approved and opened at the VA.
* PI = Principal Investigator; PO = Privacy Officer; ISO = Information Security Officer
** R&D = Research and Development
*** Many large pharmaceutical companies have an existing Master CDA and/or existing Master CRADA in place with the VA. See list of companies with Master CRADAs in place. New CRADAs are negotiated for companies with no Master CRADAs in place.