Toolbox

Blood Bank 

CRFs

DSMB (New 3-8-21)

FDA 

IRB 

Investigator's Brochure 

Monitoring

NIH Letter of Support 

Resources for Study Team 

Resources for Subjects (Updated 3-8-21)

Short Forms 

Subject Outcome Assessment 

Transfusion Adverse Reaction Form 

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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DSMB

Recommendations Letter -regarding 2/25/21 meeting (New 3-8-21)

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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 

 

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 

Letter re: enrollment stop (for participating subjects) (New 3-4-21)

English Version - - CIRB Approval notice for letter re: enrollment stop

Spanish Version (New 3-8-21)

Translation Notice

Video 

English    Spanish

Enrollment Flyer 

Spanish 

Enrollment Trifold Brochure - inside and outside 

Spanish 

*Enrollment flyer and brochure have the same content.

 

Flipbook (pictures and captions describe participation in the study) 

Spanish PowerPoint 

Spanish PDF 

 

Subject Discharge Instructions 

Spanish 

 

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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Transfusion Adverse Reaction Form (New 2-3-21)

Form Link

Complete this form whenever a C3PO study participant has a possible TRALI/septic transfusion reaction/severe allergic reaction following the administration of C3PO convalescent plasma.

The completed form should be emailed to transfusionreactions@vitalant.org.

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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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