AVSD: Atrioventricular Septal Defect (AVSD): A CHSS Inception Cohort Study
Training Document
Study Protocol
- Current Study Protocol (February 16, 2016)
- Study Protocol (Track Changes: 16 Feb 2016)
- Protocol Amendment Summary (Protocol Version Date: 16 Feb 2016)
Study Protocol (with track changes) if needed for IRB/REB Submissions:
Protocol Amendment Summary (if needed for IRB/REB submissions):
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:For Patient/Adult:
- 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)
- 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)
Data Collection Forms
- To be abstracted at the CHSS Center for Research and Quality, Toronto
- 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)
- 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)
- General Forms