Notice of Changes to Protocol Conduct (NCPC)

Principal Investigator: Click or tap here to enter text.
REB/CAPCR ID Click or tap here to enter text.	Date Created: Click or tap to enter a date. yyyy/mm/dd
Protocol ID/Number Click or tap here to enter text.: Version: Click or tap here to enter text.

Description of Specific Protocol Conduct Changes due to COVID-19
For this study this, protocol deviations include (check any that apply): ☐Replacing in-person patient visits with remote/virtual visits ☐Shipping of study intervention (e.g. mailing oral medications) ☐Changes to study procedures that do not significantly impact study integrity or participant safety ☐Arranging laboratory or other diagnostic testing to occur at alternate laboratories or clinics ☐Postponing non-essential patient visits or procedures ☐Cancelling non-essential patient visits or procedures ☐Temporarily halting study recruitment ☐Other: Click or tap here to enter text. Additional Details: Click or tap here to enter text.
Document, to the extent possible, any known impact on participant safety, privacy, confidentiality and/or data integrity and actions to mitigate risk ☐Not Applicable
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Document how any deviations will be reported ☐ Not Applicable
Planned protocol deviations that include pause in recruitment or other study activities and do not present patient safety implications do not require notification to the UHN REB – the REB must be made aware of these through the next renewal. Other planned protocol deviations may be implemented immediately prior to formal review and approval of the REB and then subsequently reported to the UHN REB in a timely manner. Additional Details (describe any additional reporting requirements to study regulators, funders or other stakeholders): Click or tap here to enter text.