SECTION 5.0 - AUDIT/INSPECTION REPORT If report’ selected in question 1.9, the following questions appear: ‘audit/inspection *Select the type of audit or inspection that was conducted: Health Canada inspection Sponsor audit (do not include standard sponsor monitoring visits) ‘for FDA audit Internal institutional audit (e.g., QA) Other If *Specify: ‘Other’: *Description/summary of the findings: *Are there findings that suggest that the research participants are at greater risk of harm than was previously known or recognized? Yes No If *Describe the increased risk: ‘Yes’: If *Describe the proposed corrective action(s) or to be taken by the sponsor and/or PI in ‘Yes’: response (select all that apply): Suspend study enrollment at this site and investigate further Implement immediate changes to reduce/eliminate hazards to current participants If Describe: ‘Other’: Upload any relevant document (e.g., correspondence, inspection/audit report or summary), if available: Upload Document SECTION 6.0 STUDY PARTICIPANT COMPLAINT – If selected in question 1.9, the following questions appear: DO NOT INCLUDE ANY INDIVIDUAL IDENTIFYING INFORMATION 6.1 *Study Participant unique study ID number/code: 6.2 *Please indicate who the complaint was made by: The study participant A family member of the study participant A friend of the study participant Other If *Please provide the relationship to the study participant: ‘Other’: 6.3 *Date of complaint: 6.4 *Please describe the nature of the complaint including to whom the complaint was made:
SECTION 5.0 - AUDIT/INSPECTION REPORT If ‘audit/inspection report’ selected in question 1.9, the following questions appear: *Select the type of audit or inspection that was conducted: Health Canada inspection Sponsor ‘for audit (do not include standard sponsor monitoring visits) FDA audit Internal institutional audit (e.g., QA) Other If ‘Other’: *Specify: *Description/summary of the findings: *Are there findings that suggest that the research participants are at greater risk of harm than was previously known or recognized? Yes No If ‘Yes’: *Describe the increased risk: If ‘Yes’: *Describe the proposed corrective action(s) or to be taken by the sponsor and/or PI in response (select all that apply): Suspend study enrollment at this site and investigate further Implement immediate changes to reduce/eliminate hazards to current participants If ‘Other’: Describe: Upload any relevant document (e.g., correspondence, inspection/audit report or summary), if available: Upload Document SECTION 6.0 – STUDY PARTICIPANT COMPLAINT If selected in question 1.9, the following questions appear: DO NOT INCLUDE ANY INDIVIDUAL IDENTIFYING INFORMATION 6.1 *Study Participant unique study ID number/code: 6.2 *Please indicate who the complaint was made by: The study participant A family member of the study participant A friend of the study participant Other If ‘Other’: *Please provide the relationship to the study participant: 6.3 *Date of complaint: 6.4 *Please describe the nature of the complaint including to whom the complaint was made:
CTO-Centre-Reportable-Event-Form_Version-16-2016MAR14.docx