Please click on the links below for helpful information pertaining to each category:
Overview Slide Set (Tues/Thurs Calls)
Readiness Checklist v.5 (UPDATED 5-17-17)
ESETT Grant (excluding budget)
August 2017 (NEW 10-6-17)
EFIC Plan Examples:
Minnesota (for enrollment site new to EFIC)
EFIC Results Report Examples (for more information contact email@example.com):
Temple (using Excel and Google Maps)
Introduction to Emergency Research
Q & A for Emergency Research
Video Transcripts (for IRB review, if being used for CC or PD)
Slide Presentation - for group CC events
Enrollment Flow Chart - supplemental slide from Utah
Self-Administered Slide Presentation - Utah example
To generate your own Self-Administered Slide Presentation visit: http://prezi.com.
Slide Set - template
Script - template
Group Survey Instrument - Spanish
Spanish Translator Certification for survey instrument
Telephone Survey - Please contact Deneil Harney at firstname.lastname@example.org.
Links to alternative opt-out tags available to offer to parents who would like to purchase a different opt-out mechanism for their child to wear on their person.
Opt-out bracelet form (Template)
Bracelet request letter (Template)
Spanish Translator Certification for Brochure and Ad (above)
Assent Form (Utah)
Child Assent 7-11 yo (Dupont)
Adolescent Assent 12-17 yo (Dupont)
LAR Notification Letter (Template)
LAR Notification Letter Example (Nationwide)
Enrollees’ and Surrogates’ attitudes toward enrollment & awareness survey.
As part of the ESETT study, enrollees and surrogates that sign a consent form or the discontinued participation page (consent addendum) should be approached to complete a study survey prior to discharge. Please submit this instrument to your IRB at the same time consents are submitted for IRB approval.
Spanish - Patient study survey
Spanish - LAR study survey
Protcol 2.0 Letter to FDA (NEW 12/5/16)
FDA Form 1572 (updated 2/16)
User Manual v.19 (NOTE: ESETT-specific information starts on p. 58)
Cassidy Conner (843-876-1105)
Kentucky Example - Bedside Enrollment/Infusion Form: PDF
*Please ensure that this document is retained as the source document. This data will need to be documented in the electronic medical record.
Simulation of a typical adult enrollment Download Video
Protocol Assist Device (PAD):
Setting Up the PAD (for Pharmacists and Study Team) Download Video
Using the PAD During an Enrollment (for Clinicians) Download Video
Additional Examples by Site:
University of Michigan
University of Michigan Resource Packet - Below are the individual files included in the packet.
Drug Infusion Guide (slides)
Children's Medical Center / UT Southwestern Medical Center
Training Binder (NEW 10-25-17)