Toolbox

Please click on the links below for helpful information pertaining to each category:

ESETT Overview

Milestones

Readiness Checklist      

IND

DSMB      

EFIC     

IRB

1572, FWA & CLIA      

WebDCU™ 

CRFs         

Clinical Resources


ESETT Overview

Overview Slide Set (Tues/Thurs Calls)

Clinical Staff Slide Set

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Milestones

NETT Hubs and PECARN Sites

NETT Spokes

NETT Hub/Spoke SOP

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Readiness Checklist v.5 (UPDATED 5-17-17)

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IND 

ESETT Grant (excluding budget)

Human Subjects

IND Information memo from study PI

IND Approval Letter

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DSMB

DSMB Roster

August 2017  (NEW 10-6-17)

February 2017 

August 2016

May 2015

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EFIC

NETT Introduction - Letter to IRB

 

NETT Spoke Defferal of EFIC Process - letter to ESETT Leadership

 

EFIC Plan Proposal

EFIC Plan Examples:

UCSF

Mass General

Minnesota (for enrollment site new to EFIC)

NETT-Spoke - EFIC Plan Cover Letter

PECARN - EFIC Plan Cover Letter (Michigan)

 

EFIC Results Report Examples (for more information contact dkolk@umich.edu):

OHSU

Temple (using Excel and Google Maps)

Utah and Supporting RedCap 

Michigan

 

FDA EFIC Guidance

 

Study Logo

 

Template Language for CC and PD Material

 

Videos

Introduction to Emergency Research

Q & A for Emergency Research

Video Transcripts (for IRB review, if being used for CC or PD)

 

CC

Community Consultation Menu

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

 

Meeting Guidance & Tips

Meeting Notice/Recruitment Flyer

Focus Group Moderator Guide

 

Group Survey Instrument

Group Survey Instrument - Spanish

Spanish Translator Certification for survey instrument

 

Self-administered Survey 

Self-administered Survey in Spanish

Spanish Translator Certification

 

Telephone Survey - Please contact Deneil Harney at dkolk@umich.edu.

 

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.

http://zoobearsmedicalid.com/

https://www.stickyj.com/medical-alert-jewelry/childrens-id-jewelry

 

Opt-out bracelet form (Template)

Bracelet request letter (Template)

 

PD

Public Disclosure Menu

Flyer

Ad             

Ad - Spanish

Brochure     

Brochure - Spanish

Spanish Translator Certification for Brochure and Ad (above)

 

Letter to Colleagues (UPenn)

PSA (Emory)

PSA (Wisconsin)

Press Release (Emory)

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IRB

ESETT IRB Letter May 2015

 

Consent Form (PDF) (Word)

Assent Form

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.

Patient study survey

Spanish - Patient study survey

LAR study survey

Spanish - LAR study survey

 

Drug Information Links

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1572, FWA & CLIA

Protcol 2.0 Letter to FDA (NEW 12/5/16)

FDA Form 1572 (updated 2/16)

NETT - 1572 Guidelines for Spokes

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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WebDCU™

WebDCU™ link

Regulatory Parameters Document

User Manual v.19 (NOTE: ESETT-specific information starts on p. 58)

CRFs 

Support:

Cassidy Conner (843-876-1105)

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CRFs

CRF Guidelines

Clinical Summary Packet Form

Redaction Instructions

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Clinical Resources 

Card for ESETT Box: PDF   Adobe Illustrator

Emory Example - Drug Administration Record / Primary Outcomes Card*: PDF   Word

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. 

 

Poster: PDF   Adobe Illustrator

 

Enrollment Video:

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.

ESETT Tips

Coordinator Enrollment Guide

Drug Administration Cards

Drug Infusion Guide (slides)

Nursing Guide

Pocket Card for Nursing Staff - Front     Back

Pocket Card for Coordinator/Physician - Front     Back

Procedure Demo for Max Dose

Social Work Guide

 

Children's Medical Center / UT Southwestern Medical Center

Badge Buddies - Attending Physicians    Pharmacy

Training Binder (NEW 10-25-17)

 

Redaction Instructions

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