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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

http://www.ncleg.net/gascripts/Statutes/StatutesTOC.pl

&

http://reports.oah.state.nc.us/ncac.asp

 

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