NMRC Clause Samples

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.
View Source

Related to NMRC

  • Supplier Diversity Seller shall comply with ▇▇▇▇▇’s Supplier Diversity Program in accordance with Appendix V.

  • Statewide HUB Program Statewide Procurement Division Note: In order for State agencies and institutions of higher education (universities) to be credited for utilizing this business as a HUB, they must award payment under the Certificate/VID Number identified above. Agencies, universities and prime contractors are encouraged to verify the company’s HUB certification prior to issuing a notice of award by accessing the Internet (▇▇▇▇▇://▇▇▇▇▇.▇▇▇.▇▇▇▇▇.▇▇.▇▇/tpasscmblsearch/index.jsp) or by contacting

  • Utilization Management Contractor shall maintain a utilization management program that complies with applicable laws, rules and regulations, including Health and Safety Code § 1367.01 and other requirements established by the applicable State Regulators responsible for oversight of Contractor.

  • Loop Provisioning Involving Integrated Digital Loop Carriers 2.6.1 Where Freedom has requested an Unbundled Loop and BellSouth uses IDLC systems to provide the local service to the End User and BellSouth has a suitable alternate facility available, BellSouth will make such alternative facilities available to Freedom. If a suitable alternative facility is not available, then to the extent it is technically feasible, BellSouth will implement one of the following alternative arrangements for Freedom (e.g. hairpinning): 1. Roll the circuit(s) from the IDLC to any spare copper that exists to the customer premises. 2. Roll the circuit(s) from the IDLC to an existing DLC that is not integrated. 3. If capacity exists, provide "side-door" porting through the switch. 4. If capacity exists, provide "Digital Access Cross Connect System (DACS)- door" porting (if the IDLC routes through a DACS prior to integration into the switch). 2.6.2 Arrangements 3 and 4 above require the use of a designed circuit. Therefore, non- designed Loops such as the SL1 voice grade and UCL-ND may not be ordered in these cases. 2.6.3 If no alternate facility is available, and upon request from Freedom, and if agreed to by both Parties, BellSouth may utilize its Special Construction (SC) process to determine the additional costs required to provision facilities. Freedom will then have the option of paying the one-time SC rates to place the Loop.

  • Program Management 1.1.01 Implement and operate an Immunization Program as a Responsible Entity 1.1.02 Identify at least one individual to act as the program contact in the following areas: 1. Immunization Program Manager;