Training Document

• AAOCA Training Document

Study Protocol

• Current Study Protocol (September 22, 2015)

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

  • Study Protocol (Track Changes: September 22 2015)
  • Study Protocol (Track Changes: June 29 2015)

  
  

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

  • Protocol Amendment Summary (Protocol Version 4 - 22 Sep 2015)
  • Protocol Amendment Summary (Protocol Version 3 - 29 Jun 2015)

Enrollment & Registration

• Patient Enrollment Form (November 19, 2018)
• Patient Demographic Information Form (generic) (November 30, 2015)

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 Consent-Assent (July 8, 2015)
• Parent/Guardian Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)
• Parent/Guardian Consent Form (February 29, 2016)
• Assent Form (February 29, 2016)

For Patient/Adult:

• Patient/Adult Consent Form (February 29, 2016)
• Patient/Adult Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)
• Patient/Adult Cover Letter with Consent Form (July 8, 2015)

Verbal Consent

• Parent/Guardian or Patient/Adult Verbal Consent Script (October 20, 2015)
• Subjects who turn 18 Verbal Consent Script (October 20, 2015)

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
      • Baseline Demographics (March 09, 2010)
      • Reason for Diagnosis (March 09, 2010)
      • Baseline Diagnostic Tests
      • Hospitalization for Surgery (March 08, 2010)
      • Ischemia Tests
      • Echo Review (March 15, 2016)
      
      
   2. REDCap Forms
      • AAOCA Imaging Review (July 21, 2016)
      
      
2. Checklists for AAOCA
   • Surgical Details Checklist (March 15, 2016)
   • Atomization Form (March 15, 2016)
   
   
3. Diagrams for AAOCA
   • Surgical Coronary Pattern Diagrams (March 15, 2016)
   • Image Coronary Pattern Diagrams (March 15, 2016)

Approval Letter

• Study Re-approval at The Hospital for Sick Children, Toronto (March 17, 2020)