Toolbox

Please click on the links below for helpful information pertaining to each category:

Readiness Checklist      

IND

DSMB      

1572, FWA & CLIA      

WebDCU™ 

CRFs         

Clinical Resources


Readiness Checklist 

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IND 

HOBIT Grant (excluding budget)

Human Subjects

IND Approval Letter

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DSMB

DSMB Roster

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1572, FWA & CLIA

FDA Form 1572 (updated 2/16)

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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WebDCU™

WebDCU™ link

Regulatory Parameters Document

CRFs 

Support:

Jodie Riley (843) 792-1453 and Teldon Alford (843) 792-3980 

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CRFs

CRF Guidelines

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Clinical Resources 

Emergency Department ICU HBO2 Checklist

Monoplace Safety Pause Checklist

Patient and Chamber Log

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