Notifications must be provided for changes to CTAs and CTA-As. The changes may be implemented immediately, but Health Canada must be informed in writing, within 15 calendar days after the day of the change. Notification changes include the following changes to CTAs and CTA-As:
a. changes to the protocol that do not affect the safety of the trial participants (changes that would not be classified as amendments)
b. information on site closure or completion of the Clinical Trial
c. when the Clinical Trial has been discontinued in its entirety or at any clinical trial site for reasons not related to the safety of clinical trial participants (e.g., for administrative purposes, lack of recruitment, etc).
Updated information regarding the change should be submitted in the form of a cover letter and any supporting documentation. This information will be reviewed and added to the file.