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Last modified March 2, 2009.

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North Carolina

State Legal Structure: Comply w/ Fed. Regulations

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Required Notification to State Officials: Any CT involving NC mental health patients, a protocol must be submitted to the Chief Exec. Office of the institution or NC DOH


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Parents & legal guardians may consent on behalf of minors &/or incompetent subjects


Age of Consent: 18-or emancipated minors


Informed Consent Requirements: Comply w/ Fed. Regulations


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: Insurance requirements only, see insurance section


HIV/AIDS Testing: All information that identifies a person w/ AIDS is confidential. Counseling must be available


Payments to Subjects: SOC must be covered


Drug Supply Requirements: Must be Labeled “For Investigational Use Only” Drug sponsor of the drug shall obtain a signed agreement with the PI stating that the PI is fully responsible


Genetic Testing: None Specified


Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified


Phases Covered: Phases II, III, & IV ONLY


Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is  NOT covered


Specific Conditions of CT Coverage: None Specified


Mandates for Coverage of Off-Label Rx: Individual & Group insurers AND managed care insurers are required to provide coverage, IF they provide coverage for prescription drugs in general


Medically Necessary Services: Medically Necessary Services NOT Covered


Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered


Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified


State Codes & Links:

All codes can be found at





Last Updated ( Wednesday, 16 September 2015 14:39 )