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Ancillary Study Application Schematic
Pediatric Quality of Life Inventory
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 New 1-11-2024
Participant Contact Information Form
Family and Household Information Form
MARF (Manuscript Analysis Request Form)
IDE
FDA IDE Approval G210126/S004 & G210126/S004/A001 - April 26 2023
FDA IDE Approval G210126-S004 - April 21 2023
FDA IDE Approval with Contingencies - December 2022
FDA IDE Approval with Contingencies - May 2021
FDA IDE Approval with Contingencies - August 2021
FDA IDE Approval with Contingencies - March 2022
FDA IDE Approval with Contingencies - June 2022
FDA IDE Approval with Contingencies - July 2022
FDA IDE Approval with Contingencies - October 2022
IRB
Protocol Approval with Modifications - Version 4 New 4/2/24
Pediatric Quality of Life Inventory
English
Spanish
Readiness Checklist
Sample - Note this is a sample document, the CCC will send your site an editable version
Resources
The following resources have been provided for your use. Please note that these are not official P-ICECAP documents. Most have been shared by sites to save you time.
Always refer to the Protocol, MOP, CRF Completion Guidelines and the Clinical Standardization Guidelines for approved, study-related information.
3 and 12 month Post CA Window Calculator
C.S. Mott P-ICECAP Ordersets -PDFs
CHOP Pediatric Cardiac Arrest Clinical Pathway
Esophageal Probe Placement Slides
Follow-up Family Reminder Card
Kennedy Krieger Institute Phone Numbers
P-ICECAP Incl-Excl Screening Checklist