Toolbox

Blood Bank 

CRFs 

FDA 

IRB 

Investigator's Brochure 

Monitoring

NIH Letter of Support 

Resources for Study Team (Updated 12-1-20)

Resources for Subjects (Updated 12-3-20)

Short Forms 

Subject Outcome Assessment 

1572, FWA & CLIA 


 

 

Blood Bank 

FINs with Associated FEI (registration #) 

 

Product Facility Codes 

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CRFs 

CRF Completion Guidelines 

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FDA 

Advice/Information Request FDA Letter June 2020 

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IRB 

Protocol Version 4 Approval Letter  

Protocol Version 3 Modification Approval Letter

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

Framework for Discussing mABs with Potential Subjects (New 12-1-20)

 

Placebo Labels - Printing Instructions 

  1. Use blank labels (4”x 4” - 4 labels per page)

Options:

Avery Presta   94100 - 400 labels for $23 (avery.com)

Online Labels   OL3027 - 400 labels for $18.95 (onlinelabels.com)

       2. PDF files are by blood type and will print 4 per page

 

Order Set Examples:

Cerner (Detroit Receiving) 

Epic (Spectrum Health and Butterworth Hospitals) 

 

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 

Enrollment Flyer 

Spanish (New 12-3-20)

Enrollment Trifold Brochure - inside and outside 

Spanish (New 12-3-20)

*Enrollment flyer and brochure have the same content.

 

Flipbook (pictures and captions describe participation in the study) 

Spanish PowerPoint (New 12-3-20)

Spanish PDF (New 12-3-20)

 

Subject Discharge Instructions 

Spanish (New 12-3-20)

 

Subject Handout (describes convalescent plasma therapy)

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Subject Outcome Assessment 

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 

 

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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