Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight


Implementation of Modifications Requiring a CTA-A

The Office of Compliance and Oversight has updated its policy regarding implementation of modifications requiring a Clinical Trial Application Amendment (CTA-A) with Health Canada. Moving forward for applicable modifications, following Central Office receipt and review of REB approval documents (and approved local consents as applicable), centres will receive an email 'confirmation of implementation' from Central Office. This email will indicate the implementation date of the approved modification at the centre. Centres will be expected to begin implementing the modification on the implementation date.

This change only affects trial modifications sent to Health Canada as a CTA-A after Friday, April 12. This change does not apply to immediate implementation safety modifications (which must be implemented immediately) or modifications that do not involve submission to Health Canada as a CTA-A (which should continue to be implemented upon REB approval).

Further details can be found in "News and Updates" on the Office of Compliance and Oversight (OCO) website (http://www.ctg.queensu.ca/private/compliance/default.html).

If you have any questions about this, please contact your centre's Ethics Research Associate.