Toolbox


CRFs

CMS Coverage

Consent Template

DSMB Letters

FWA & CLIA

Glucostabilizer

Hypoglycemia Resources 

IRB Template

Medicare Coverage

mRS Scoring and Sample Cases

Pharmacy Plans and Drug Order Sets 

Protocol 

Readiness Checklist

Recruitment Plan

SAE Templates

Screening

Site Guidance

Snack List

Staffing Plan

Statistical Analysis Plan

Translated Materials

Other (Updated 12-4-17)


 

CRFs
CRFs v.12

CRF Reminders from Study Coordinator Meeting 2-7-17 

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CMS Coverage
CMS Coverage Summary

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Consent Template
*Please send your Consent Forms for CCC-review at SHINE‐Milestone@umich.edu BEFORE you submit to your IRB. For more information regarding this click here.
 

Consent Template v.3.1 (includes OmniTrace language) 

OmniTrace Introductory Memo 

Copy of Patient Information Form 

OmniTrace FAQs 

 

Consent Template v.3
 

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DSMB Letters

April 2017

May 2016

December 2015
July 2015
January 2015
August 2014
January 2014
June 2013
December 2012
June 2012
November 2011 - Protocol Approval
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FWA & CLIA

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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GlucoStabilizer

 

Instructions for Accessing History

 

Instructions for Starting a New Drip and Resuming a Drip
Quick Guide
Slides

Demo Site for SHINE Study Portal
Test Subject ID Codes

Windows Updates Instructions (New 2-5-15)

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Hypoglycemia Resources
Hypoglycemia Electronic Form Overview
Meals Documentation Electronic Form Overview
Hypoglycemia Protocol and Sympotomatic Questionnaire (Updated 8-1-17)

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IRB Template
SAMPLE IRB Submission Template

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Medicare Coverage
Medicare Coverage for Clinical Trials: Financial National Coverage Decision

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mRS Scoring Pocket Cards and Sample Cases
Pocket Cards (Protocol v.2)
Sample Cases

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Pharmacy Plans and Drug Order Sets
*Please send your Pharmacy Plan and Drug Order Sets to shine-milestones@umich.edu for review per NETT Document review guidelines. For more information regarding this click here.

Pharmacy Plan Guidance 

Pharmacy Plan/Drug Order Set Examples:
Cincinnati
Georgia Health Sciences University
University of Texas
University of Utah
University of Virginia
West Virginia University

D50 Shortage Alternatives 

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Protocol
Brief Protocol Overview Training
Click on the heading above for a short protocol overview to use with new team members or as a refresher for experienced team members. NOTE: This does NOT replace the Protocol Training above required for team members on the DOA log.

Treatment Protocol Reminders (Updated 8-16-17)
Intervention Protocol Mock Patient Instructions:
Use the following as training materials or a refresher for the intervention protocol.

SHINE Mock Patient-Intervention Group: Use this as your guide.
As you progress through this worksheet, answer any questions listed in bold.  Also, enter New Events as appropriate in the study laptops (i.e., date/time of POC glucose checks, POC glucose results, rate of the IV saline, any SQ injections, and other notes into the Demo Site for the Control Treatment Screen on the study laptop.  As a reminder, to access the demo site, after opening the SHINE Trial Portal, click the link that displays ‘Please click here for the test/demo site’ and enter one of the 3-digit SHINE subject IDs posted in the toolbox).

After completing this worksheet and entries, refer to the other two documents for correct answers and reminders about the control protocol.
SHINE Mock Patient-Intervention Group Screen: This is a screen shot of Intervention Group Screen with all correct entries.
SHINE Mock Patient-Intevention Group (with answers): This shows the correct answers to the bolded questions.

Control Protocol Mock Patient Instructions:
Use the following as training materials or a refresher for the control protocol.

SHINE Mock Patient-Control Group: Use this as your guide. 

As you progress through this worksheet, answer any questions listed in bold.  Also, enter New Events as appropriate in the study laptops (i.e., date/time of POC glucose checks, POC glucose results, rate of the IV saline, any SQ injections, and other notes into the Demo Site for the Control Treatment Screen on the study laptop.  As a reminder, to access the demo site, after opening the SHINE Trial Portal, click the link that displays ‘Please click here for the test/demo site’ and enter one of the 3-digit SHINE subject IDs posted in the toolbox).

After completing this worksheet and entries, refer to the other two documents for correct answers and reminders about the control protocol.
SHINE Mock Patient-Control group screen: This is a screen shot of Control Treatment Screen with all correct entries.
SHINE Mock Patient- Control Group: This shows the correct answers to the bolded questions.

SHINE Meals and Pause Protocol Resources: (NEW 9-4-14)
Questions about meals and pausing are common during the SHINE treatment protocol.  Brief info sheets with screenshots have been developed for each to share with your study team and clinical nurses.  These are provided as word documents that can be edited to include site-specific details if desired.
Instructions for Pauses in Intervention Protocol
Instruction for Pauses in Control Protocol

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Readiness Checklist
*Please send your Readiness Checklist to shine-milestones@umich.edu for review per NETT Document review guidelines. For more information regarding this click here.

SHINE Readiness Checklist v.3 

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Recruitment Plan

*Please send your Recruitment Plan to shine-milestones@umich.edu for review per NETT Document review guidelines. For more information regarding this click here.

Recruitment Plan Guidance

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SAE Templates

Hemmorrhage
Hypoglycemia
Neurological Worsening
Pneumonia

Stroke

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Screening
Eligibility Criteria Pocket Card v.2
Screening Tool - University of Virginia Example
Screening Tool - University of Michigan Example

Publication on Screening Tool in Stroke Sept. 2016

Screen Failure Log Entry Tool 

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Site Guidance

Endovascular Treatment Results

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Snack List - Protocol Approved
Snacks 

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Staffing Plan
Utilizing Nurse Technicians - University of Kentucky's Plan

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Statistical Analysis Plan
IRB Synopsis for SHINE Interim Statistical Analysis Plan

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Translated Materials
SSQOL (Mass General):       

Spanish version     

Translator Certificate

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Other
NS IV Bag Shortage Alternatives - This document lists IV bag alternatives due to the shortage that resulted from Hurrican Maria. (NEW 12-4-17)

CME Flyer - Distribute this flyer to your SHINE study team to inform them of another educational opportunity to learn about the SHINE Trial in 5 brief videos and earn 2 CMEs at the same time.

Control Group Timing Spreadsheets - Optional tools to auto-populate timing of glucose checks and insulin dosing in the control group.  Our thanks to Laura Buchwalder at Ohio State’s Wexner Medical Center for her efforts in developing one of these two available resources.

Control Timesheet

  • Entering treatment start time:
  • This time can be entered either as 24 hour clock or 12 hour clock with AM/PM. For example, 5:46 pm can be entered as :
  • 17:46
  • 17:46:00
  • 5:46 PM
  • 5:46:00 PM
  • 05:46:00 PM
  • Note- If you enter as 24 hour clock, please make sure the AM/PM is deleted. Otherwise, you will get an error after you hit enter with this time
  • (e.g. 17:46 PM would get error).

Intervention Group Meal Log  

Retention Tips and Tricks 

SHINE Badge (attaches to name badge) -Pittsburgh Example
Includes inclusion/exclusion criteria and important contact information, but information can be customized to your site's needs.

Slides from September Study Coordinator Call 

Redaction Instructions

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