DSMB (New 3-8-21)
Resources for Subjects (Updated 3-8-21)
Transfusion Adverse Reaction Form
FINs with Associated FEI (registration #)
Recommendations Letter -regarding 2/25/21 meeting (New 3-8-21)
Advice/Information Request FDA Letter June 2020
Protocol Version 4 Approval Letter
Protocol Version 3 Modification Approval Letter
Protocol Version 2 Approval with Modifications Letter
Protocol Approval with Modifications Letter
Steps to Obtain EMR Access for Monitors
Framework for Discussing mABs with Potential Subjects
Placebo Labels - Printing Instructions
- 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)
ED Staff Pocket Card -Rapid Test (Publisher) or PDF
ED Staff Pocket Card -No Test (Publisher) or PDF
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)
Video
Enrollment Trifold Brochure - inside and outside
*Enrollment flyer and brochure have the same content.
Flipbook (pictures and captions describe participation in the study)
Subject Discharge Instructions
Subject Handout (describes convalescent plasma therapy)
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
Transfusion Adverse Reaction Form (New 2-3-21)
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.
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