Canadian Cancer Trials Group Bulletins

Ethics Regulatory


Annual Re-Approval Requirements for NCI US-Affiliated Trials

The Ethics and Regulatory Group has posted the following memo regarding annual re-approval requirements for NCI US-affiliated trials. This memo clarifies what constitutes a protocol-mandated intervention:

Memo Re: Annual Re-approval Requirements for NCI US-Affiliated Trials.

Specifically, quality of life (QOL) questionnaires are considered to be protocol-mandated interventions and thus full board annual re-approvals are required until, at minimum, all patients have completed the QOL questionnaires as outlined in the protocol.

In addition, the information on the Canadian Cancer Trials Group external website pertaining to the annual re-approval requirements has been updated. Please see http://www.ctg.queensu.ca/private/ethics/ethics/annual_re-approval.html for further information.

Please don't hesitate to contact your centre's Ethics Research Associate if you have any questions.