Toolbox

CRFs

Ceding Resources

Clinical Team Resources

DSMB

e-Consent 

FWA & CLIA

IDE

IRB

Milestones and Payments

Participant Reimbursement Policy

Readiness Checklist

Screening

Short Forms 

Statistical Analysis Plan


 

CRFs

CRF Completion Guidelines

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Ceding Resources

Smart IRB Cheat Sheet

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Clinical Team Resources

Education Booklet 

Poster for Resuscitation Bay

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DSMB

DSMB Roster (coming soon)

 
 

e-Consent 

Electronic Informed Consent SOP (description of the central IRB-approved eConsent process)

All ICECAP sites should plan to use the electronic version of the consent form, with paper consent available as a last resort. The eConsent platform, Redcap, has been approved by the central IRB for eConsent use in ICECAP. A unique eConsent form link for your site will be provided to you after your site application has received central IRB approval. 

e-Consent Checklist (coming soon)

 

 

FWA & CLIA

SIREN-NETT - FWA Requirements for Spokes

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

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

 

IDE

IDE Approval Letter  6/9/16

Approval letter with conditions 4/29/16

 

 

Milestones and Payments

ICECAP Milestones and payments

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Participant Reimbursement Policy

SIREN Reimbursement Policy

ICECAP IRB Approval of Reimbursement Policy

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Readiness Checklist

Checklist (Please note your site manager will send you a site specific link once you are at that stage in the process)

 

 

Screening

Screening Log