Toolbox

Blood Bank (Updated 9-9-20)

CRFs 

FDA 

IRB (Updated 9-10-20)

Investigator's Brochure 

Monitoring

NIH Letter of Support 

Protocol with Tracked Changes

Resources for Study Team (Updated 9-4-20)

Resources for Subjects 

Subject Outcome Assessment 

1572, FWA & CLIA 


 

 

Blood Bank 

FINs with Associated FEI (registration #) (New 9-9-20)

Product Facility Codes (Updated 9-4-20)

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CRFs 

Studybook (includes all the trial's CRFs)

CRF Completion Guidelines 

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FDA 

Advice/Information Request FDA Letter June 2020 

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IRB 

Protocol Version 3 Modification Approval Letter (New 9-10-20)

Protocol Version 2 Approval with Modifications Letter 

Protocol Approval with Modifications Letter

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Monitoring 

Steps to Obtain EMR Access for Monitors 

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Resources for Study Team

Order Set Examples:

Cerner (Detroit Receiving) (New 9-4-20)

Epic (Spectrum Health and Butterworth Hospitals) (New 9-3-20)

Provider Poster

Study Coordinator Guide

ED Staff Pocket Card -Rapid Test (Publisher)  or PDF

ED Staff Pocket Card -No Test (Publisher) or PDF

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Resources for Subjects 

Placebo Labels (New 7-22-20)

Subject Handout (describes convalescent plasma therapy)

Subject Discharge Instructions (New 7-22-20)

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Subject Outcome Assessment (New 7-30-20)

Registration for Outcome Assessment

Instructions for registering for outcome assessment by the central follow-up team (Registration instructions for Stanford REDCap -to be completed only by participants who are randomized and before discharge from the emergency department)

Instructions Video Tutorial 

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1572, FWA & CLIA 

FDA Form 1572 

1572 Preparation (Updated 8-5-20)

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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