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Ancillary Study Policy

Ancillary Study Application Schematic

Consent Practice Tools

Forms & Logs

IDE

IRB

Pediatric Qualtiy of Life Inventory

Resources 

Statistical Design

CRF Completion Guidelines

 

Ancillary Study Policy

P-ICECAP Ancillary Study Policy (Google Doc)

*PDF available upon request

SIREN Ancillary/Substudy Approval process

Ancillary Study Application Schematic

 

Consent Practice Tools

P-ICECAP E-consent Practice Enviornment

P-ICECAP E-consent Practice Enviornment with Bill of Rights and HIPAA sections

 

Forms & Logs

Temperature Recording Aid

Participant Contact Information Form 

Contact Tracking Log

Family and Household Information Form

 

IDE

FDA IDE Approval with Contingencies - May 2021 (Updated 11/3/22)

FDA IDE Approval with Contingencies - August 2021 (Updated 11/3/22)

FDA IDE Approval with Contingencies - March 2022 (Updated 11/3/22)

FDA IDE Approval with Contingencies - June 2022  (Updated 8/11/22)

FDA IDE Approval with Contingencies - July 2022 (Updated 8/11/22)

FDA IDE Approval with Contingencies - October 2022 (Updated 10/27/22)

 

IRB

Protocol Approval with Modifications - Version 2 (Updated 8/11/22)

 

Pediatric Quality of Life Inventory 

English 

2 days - 12 months

13 months - <2 years

2 - 4 years

5 - 7 years

8 - 12 years

13 - 18 years

Spanish (Updated 6/2/22)

2 days - 12 months SPANISH

13 months - <2 years SPANISH

2 - 4 years SPANISH

5 - 7 years SPANISH

8 - 12 years SPANISH

13 - 18 years SPANISH

 

Resources

Age Calculator

C.S. Mott P-ICECAP Ordersets -PDFs

CHOP Pediatric Cardiac Arrest Clinical Pathway

CHOP PICECAP Orderset

Educational Information Sheet

Eligibility Checklist with Critical Times

Follow-up Family Reminder Card

P-ICECAP Unit Flyer

P-ICECAP Incl-Excl Screening Checklist

3 and 12 month Post CA Window Calculator

Workflow Checklist from CHOM

 

Statistical Design

Statistical Design and Power Adaptive Design Report