Training Document

• AVSD Training Document

Study Protocol

• Current Study Protocol (February 16, 2016)

Study Protocol (with track changes) if needed for IRB/REB Submissions:

• Study Protocol (Track Changes: 16 Feb 2016)




Protocol Amendment Summary (if needed for IRB/REB submissions):

• Protocol Amendment Summary (Protocol Version Date: 16 Feb 2016)

Enrollment & Registration

• Patient Enrollment Form (November 19, 2018)
• Patient Demographic Information Form (generic) (February 17, 2016)

Approval Letter

• Study Re-approval Letter at The Hospital for Sick Children, Toronto (January 17, 2019)

Consent & Assent and Cover Letters

Consent and Assent forms are provided for reference only. Please follow local institutional guidelines for consent and/or assent.

For Parent/Guardian:

• Parent/Guardian Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)
• Parent/Guardian Consent Form (March 15, 2016)
• Assent Form (March 15, 2016)

For Patient/Adult:

• Patient/Adult Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)
• Patient/Adult Consent Form (March 15, 2016)

Generic Documents (Scripts, Participant Letters, and Questionnaires)

• Generic Documents

Data Collection Forms

1. To be abstracted at the CHSS Center for Research and Quality, Toronto
   
   
   1. General Forms
      • Contact Information Form (February 17, 2016)
      • Administration Form (February 17, 2016)
      • Clinic Form (February 17, 2016)
      • Catheterization Form (February 17, 2016)
      • Diagnosis Form (February 17, 2016)
      • Other Surgical Procedure Form (February 17, 2016)
      • Surgical Repair Form (February 17, 2016)
      • General Information Surgical Form (February 17, 2016)
      • Autopsy Form (February 17, 2016)
      
      
   2. REDCap Forms
      • Demographics (November 13, 2015)
      • Baseline Echo (November 13, 2015)
      • Baseline Echo Quality Check (November 13, 2015)
      • Predischarge Single Ventricle (November 13, 2015)
      • Predischarge Single Ventricle Quality Check (November 13, 2015)
      • Predischarge Two Ventricle (November 13, 2015)
      • Predischarge Two Ventricle Quality Check (November 13, 2015)
      • 1 Year Follow Up Single Ventricle (November 13, 2015)
      • 1 Year Follow Up Single Ventricle Quality Check (November 13, 2015)
      • 1 Year Follow Up Two Ventricle (November 13, 2015)
      • 1 Year Follow Up Two Ventricle Quality Check (November 13, 2015)