All prospective Principal Investigators (PIs) should contact LAVREC’s Executive Director to discuss opening a clinical research trial at the Southeast Louisiana Veterans Health Care System (SLVHCS). PIs and research staff are required to be affiliated with SLVHCS prior to initiating any clinical research trial with LAVREC. Prospective PIs without current affiliation should contact the Joseph Constans, Associate Chief of Staff for Research, to discuss possible affiliation.
Opening a clinical study requires a great deal of preliminary paperwork as well as approval by various entities at the VA. LAVREC can assist PIs with this process, which includes:
Negotiation and preparation of Confidential Disclosure Agreement (CDA)
Assistance with budget negotiations between study sponsor and PI
Negotiation and preparation of Collaborative Research and Development Agreement (CRADA)
Preparation and submission of documents required for approval of study by Institutional Review Board (IRB)
Submission of IRB-approved study to the VA’s Safety and Research & Development (R&D) committees for approval
Preparation and submission of modification and/or continuing approval documents to the IRB as required
Assistance with internal audits of the study conducted by the Regional Compliance Officer