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FDA (New 6-16-20)

IRB (New 6-24-20)

Monitoring (New 6-24-20)

Resources for Subjects (New 6-24-20)

1572, FWA & CLIA (New 6-18-20)


 

 

FDA (New 6-16-20)

Advice/Information Request FDA Letter June 2020 (New 6-16-20)

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IRB (New 6-24-20)

Protocol Approval with Modifications Letter

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Monitoring (New 6-24-20)

Steps to Obtain EMR Access for Monitors 

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Resources for Subjects (New 6-24-20)

Subject Handout (describes convalescent plasma therapy)

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1572, FWA & CLIA (New 6-18-20)

FDA Form 1572 

1572 Guidelines for Spokes

SIREN-NETT - FWA Requirements for Spokes

FWA Look up: http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc

CLIA Look up: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.html

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