Table 5 Adverse events reporting
Study Period/Reporting Procedure | Adverse Event Reporting | SAE Reporting |
|---|---|---|
From time patient signs the consent form until 30 days after end of study treatment. | Yes | Yes |
Thirty days after the end of study intervention until the last follow up date. | Yes, if assessed as related or possibly related to the treatment/intervention by the Investigator. | Yes, if assessed as related or possibly related to the treatment/intervention by the Investigator. |
How to report | Source documents (e.g., study-specific worksheets) and case report form. | SAEs, unexpected, related/possibly related to be reported through a SAE form to the PI (sponsor) with copy to the Investigator-Initiated Trials team within 24 hours REB/Health Canada to be notified within applicable timeframe. |