NMRC Sample Clauses

NMRC sponsor and primary research organization: NMRC, as sponsor, will submit and hold the IND, will be responsible for negotiating protocol requirements with FDA as needed, and, will be responsible for all obligations of the IND sponsor as set forth in 21 CFR Part 312, including but not limited to study regulatory reporting and appropriate correspondence with the FDA including SAE reporting. NMRC investigators will be responsible for preparing the protocol; securing NMRC IRB, BUMED and other DoD approvals; submitting SAE and periodic reports to the NRMC IRB; and educating trauma center and EMS teams on protocol implementation; the EIC/CCD process (in collaboration with the trauma centers’ IRBs and investigators); and optimal treatment of HBOC-treated patients. NMRC will provide for data management; study monitoring; and preparation of data for DMC ESRs and program “accrual” reviews. Collaboratively, NMRC, and study investigators will be responsible for reporting data results at scientific/medical meetings and preparing manuscripts for publication in peer reviewed journals. NMRC will be responsible for recruitment of level I trauma centers and respective trauma center investigators, execution of Cooperative Agreements or other subcontracts, and assurance of trauma center IRB approvals. NMRC investigators, in collaboration with trauma center investigators, will be responsible for reporting the overall results of the trial, including demographic characteristics of the population studied, to the respective trauma center communities in a mechanism as determined by the trauma centers’ IRBs.